In Vitro Fertilization
Conditions
Keywords
Infertility, Pharmacological effects of drugs, Hormones, Hormone Substitutes and Hormone Antagonists, Pharmacological Actions, Multi-center
Brief summary
The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.
Detailed description
This trial is designed as an open-label, uncontrolled, repeated cycle trial to assess the non-immunogenicity and safety of corifollitropin alfa in participants undergoing repeated COS cycles for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a multiple dose GnRH antagonist protocol. The trial period per participant will cover 1, 2 or 3 COS treatment cycles and no more than three (in-between two stimulation cycles) Frozen-Thawed Embryo Transfer (FTET) cycles following either or both of the first two treatment cycles. In each stimulation cycle, participants receive a single injection of corifollitropin alfa and one week later, treatment is continued with a daily dose of any FSH-containing preparation up to the day of (rec)hCG administration for final oocyte maturation. Assessment of anti-corifollitropin alfa antibodies and local tolerance after corifollitropin alfa injection are important safety endpoints in this trial.
Interventions
DRUGCorifollitropin alfa
Corifollitropin alfa 150 µg administered as a single subcutaneous dose.
BIOLOGICALFSH
FSH administerd subcutaneously at a dose not to exceed 225 IU/day.
BIOLOGICALGnRH antagonist
GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.
BIOLOGICAL(rec)hCG
(rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.
DRUGProgesterone
Progesterone administered vaginally at a dose of at least 600 mg/day.
Sponsors
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Females of couples with an indication for COS and IVF or ICSI; * \>=18 and \<=39 years of age at the time of signing informed consent; * Body weight \> 60 kg and body mass index (BMI) \>=18 and \<=29 kg/m\^2; * Normal menstrual cycle length: 24-35 days; * Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed); * Willing and able to sign informed consent.
Exclusion criteria
* History of or any current (treated) endocrine abnormality; * History of ovarian hyper-response or history of ovarian hyperstimulation syndrome (OHSS); * History of or current polycystic ovary syndrome (PCOS); * More than 20 basal antral follicles (size: \<11 mm, both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5); * Less than 2 ovaries or any other ovarian abnormality, including endometrioma \>10 mm (visible on USS); * Presence of unilateral or bilateral hydrosalpinx (visible on USS); * More than three unsuccessful COS cycles since the last established ongoing pregnancy (if applicable); * History of non- or low ovarian response to FSH/human menopausal gonadotrophin (hMG) treatment; * FSH \> 12 IU/L or luteinizing hormone (LH) \> 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5); * Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase, including abnormal cervical smear (Papanicolaou \[PAP\]\>=III, cervical intraepithelial neoplasia \[CIN\]\>=1); * Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH antagonists (e.g. hypersensitivity, pregnancy/lactation); * Recent history of or current epilepsy, human immunodeficiency virus (HIV) infection, thrombophilia, diabetes or cardiovascular, gastro-intestinal, hepatic, renal, or pulmonary disease; * Abnormal karyotyping of the participant or her partner (if karyotyping is performed); * History or presence of alcohol or drug abuse within 12 months prior to signing informed consent; * Previous use of corifollitropin alfa; * Use of hormonal preparations within 1 month prior to screening; * Administration of investigational drugs within three months prior to signing informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinically Relevant Immunogenicity | Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle | Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present. |
| Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles | 30 minutes post dose in each treatment cycle | At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis. |
| Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles | 30 minutes post dose in each treatment cycle | At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis. |
| Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles | 30 minutes post dose in each treatment cycle | At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis. |
| Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles | 30 minutes post dose in each treatment cycle | At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis. |
| Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles | 30 minutes post dose in each treatment cycle | At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis. |
| Number of Participants With AEs | Up to approximately 26 months after first dose of corifollitropin alfa | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Number of Participants With Serious AEs (SAEs) | Up to approximately 26 months after first dose of corifollitropin alfa | An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa. |
| Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) | Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle | OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size \>10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3 | Stimulation Day 8 in Treatment Cycle 3 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1 | Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 1 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2 | Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 2 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3 | Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 3 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded. |
| Number of Oocytes Retrieved in a Participant Among Entire Study Population | Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle | Oocyte retrieval, also known as oocyte pick-up, is a technique used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The number of oocytes retrieved, per participant, is summarized. |
| Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 | Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 1 | This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 1. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures. |
| Number of Fertilized Oocytes Obtained in Treatment Cycle 2 | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2 | This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN). |
| Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 | Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 2 | This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 2. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures. |
| Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 | Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 3 | This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 3. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures. |
| Number of Fertilized Oocytes Obtained in Treatment Cycle 1 | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1 | This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of pronuclei (PN) present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN). |
| Number of Fertilized Oocytes Obtained in Treatment Cycle 3 | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3 | This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN). |
| Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1 | This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN). |
| Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 | Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3 | At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality. |
| Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2 | This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN). |
| Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3 | This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN). |
| Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1 | This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN). |
| Number of Embryos Transferred | At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle | ET is the procedure in which one or more embryos are placed in the uterus. The number of embryos transferred, per participant, is summarized. |
| Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2 | This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN). |
| Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3 | This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN). |
| Fertilization Rate | 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle | The fertilization rate (in percent) is defined as 100 times the ratio of the number of fertilized 2 PN oocytes obtained and the number of oocytes that was used for fertilization, per participant. |
| Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 | Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1 | At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality. |
| Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 | Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2 | At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality. |
| Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 | At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1 | The number of embryos transferred, for each participant, by category of number of good quality embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality. |
| Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 | At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2 | The number of embryos transferred, for each participant, by category of number of good quality embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality. |
| Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 | At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3 | The number of embryos transferred, for each participant, by category of number of good quality embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality. |
| Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 | Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1 | The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality. |
| Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 | Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2 | The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality. |
| Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 | Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3 | The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality. |
| Implantation Rate for Participants With ET | Approximately 5-6 weeks after ET, within a treatment cycle | The implantation rate (in percent) is defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan after ET divided by the number of embryos transferred per participant. |
| Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3 | 5-6 weeks up to 9 months after ET, within a treatment cycle | Miscarriage: Loss of the fetus without induction or instrumentation, also known as spontaneous abortion. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. |
| Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 | ≥14 days (for biochemical pregnancy), 5-6 weeks (for clinical pregnancy), 5-6 weeks to 10 weeks (for vital pregnancy) and 10 weeks up to 9 months (for ongoing pregnancy) after ET, within a treatment cycle | Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth. |
| Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 | 10 weeks up to 9 months after ET, within a treatment cycle | Singleton pregnancy is a pregnancy in which one fetus develops in the uterus. Multiple pregnancy is a pregnancy in which more than one fetus develops simultaneously in the uterus. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth. |
| Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3 | 5-6 weeks up to 9 months after ET, within a treatment cycle | Miscarriage: Loss of the fetus without induction or instrumentation, also known as spontaneous abortion. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. |
| Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG | Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle | Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated. |
| Number of Participants With Ongoing Pregnancy in Any FTET Cycle | 10 weeks up to 9 months after ET within an FTET cycle | After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. This measure summarizes the number of participants with ongoing pregnancy following ET within an FTET cycle. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth. |
| Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy | Up to approximately 26 months after first dose of corifollitropin alfa | The ongoing pregnancy rate, cumulative over the entire study (in percent), is defined as 100 times the number of participants who had an ongoing pregnancy in Treatment Cycles 1, 2 or 3, or in any FTET cycle, or who had a spontaneous ongoing pregnancy, divided by the total number of participants who were administered corifollitropin alfa in the study. A participant could only be represented once in the count of ongoing pregnancies for determination of cumulative ongoing pregnancy rate. After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. A spontaneous pregnancy is a pregnancy that was not considered to have resulted from ET in a treatment cycle or FTET cycle. |
| Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1 | Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum FSH Levels in Treatment Cycle 2 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2 | Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum FSH Levels in Treatment Cycle 3 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3 | Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1 | Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum LH Levels in Treatment Cycle 2 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2 | Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum LH Levels in Treatment Cycle 3 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3 | Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Estradiol Levels in Treatment Cycle 1 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1 | Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Estradiol Levels in Treatment Cycle 2 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2 | Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Estradiol Levels in Treatment Cycle 3 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3 | Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Progesterone Levels in Treatment Cycle 1 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1 | Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Progesterone Levels in Treatment Cycle 2 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2 | Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Progesterone Levels in Treatment Cycle 3 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3 | Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Inhibin-B Levels in Treatment Cycle 1 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1 | Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Inhibin-B Levels in Treatment Cycle 2 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2 | Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Serum Inhibin-B Levels in Treatment Cycle 3 | Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3 | Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET. |
| Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3 | From 2 weeks up to approximately 5-6 weeks after ET, within a treatment cycle | Ectopic pregnancy: A pregnancy in which the embryo attaches itself in a place other than inside the uterus. The most common site for an ectopic pregnancy is within one of the two fallopian tubes. Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1 | Stimulation Day 1 in Treatment Cycle 1 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2 | Stimulation Day 1 in Treatment Cycle 2 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3 | Stimulation Day 1 in Treatment Cycle 3 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1 | Stimulation Day 5 or 6 in Treatment Cycle 1 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2 | Stimulation Day 5 or 6 in Treatment Cycle 2 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3 | Stimulation Day 5 or 6 in Treatment Cycle 3 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1 | Stimulation Day 8 in Treatment Cycle 1 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated. |
| Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2 | Stimulation Day 8 in Treatment Cycle 2 | For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated. |
Participant flow
Pre-assignment details
To complete study, a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3).
Participants by arm
| Arm | Count |
|---|---|
| Corifollitropin Alfa 150 µg Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur. | 682 |
| Total | 682 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Other reason (not specified) | 55 |
| Overall Study | Pregnant prior to Treat Cycle 3 | 304 |
| Overall Study | Stop Treat Cycle 3 not for Adverse Event | 18 |
| Overall Study | Trial stopped | 32 |
| Overall Study | Withdrawal by Subject | 87 |
Baseline characteristics
| Characteristic | Corifollitropin Alfa 150 µg |
|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 3.6 |
| Sex: Female, Male Female | 682 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 239 / 682 |
| serious Total, serious adverse events | 51 / 682 |
Outcome results
Primary
Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles
At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis.
Time frame: 30 minutes post dose in each treatment cycle
Population: Participants who received corifollitropin alfa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles | None | 679 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles | Mild | 3 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles | Moderate | 0 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles | Severe | 0 participants |
Primary
Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles
At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis.
Time frame: 30 minutes post dose in each treatment cycle
Population: Participants who received corifollitropin alfa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles | None | 678 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles | Mild | 4 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles | Moderate | 0 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles | Severe | 0 participants |
Primary
Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles
At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis.
Time frame: 30 minutes post dose in each treatment cycle
Population: Participants who received corifollitropin alfa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles | None | 654 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles | Mild | 28 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles | Moderate | 0 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles | Severe | 0 participants |
Primary
Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles
At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis.
Time frame: 30 minutes post dose in each treatment cycle
Population: Participants who received corifollitropin alfa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles | Moderate | 0 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles | None | 680 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles | Mild | 2 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles | Severe | 0 participants |
Primary
Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles
At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis.
Time frame: 30 minutes post dose in each treatment cycle
Population: Participants who received corifollitropin alfa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles | None | 647 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles | Mild | 35 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles | Moderate | 0 participants |
| Corifollitropin Alfa 150 µg | Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles | Severe | 0 participants |
Primary
Number of Participants With AEs
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: Up to approximately 26 months after first dose of corifollitropin alfa
Population: Participants who received corifollitropin alfa
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants With AEs | 409 participants |
Primary
Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS)
OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size \>10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.
Time frame: Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle
Population: Participants who received corifollitropin alfa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) | Cycle 1 (n=682) | 12 participants |
| Corifollitropin Alfa 150 µg | Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) | Cycle 2 (n=375) | 4 participants |
| Corifollitropin Alfa 150 µg | Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) | Cycle 3 (n=198) | 0 participants |
Primary
Number of Participants With Serious AEs (SAEs)
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.
Time frame: Up to approximately 26 months after first dose of corifollitropin alfa
Population: Participants who received corifollitropin alfa
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants With Serious AEs (SAEs) | 51 participants |
Primary
Percentage of Participants With Clinically Relevant Immunogenicity
Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present.
Time frame: Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle
Population: Participants who received corifollitropin alfa and had a post dose sample for anti-corifollitropin alfa antibody testing
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Percentage of Participants With Clinically Relevant Immunogenicity | Cycle 1 (n=681) | 0.0 percentage of participants |
| Corifollitropin Alfa 150 µg | Percentage of Participants With Clinically Relevant Immunogenicity | Cycle 2 (n=372) | 0.0 percentage of participants |
| Corifollitropin Alfa 150 µg | Percentage of Participants With Clinically Relevant Immunogenicity | Cycle 3 (n=192) | 0.0 percentage of participants |
Comparison: During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.
Comparison: During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.
Comparison: During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.
Secondary
Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG
Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated.
Time frame: Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle
Population: Participants who received corifollitropin alfa and (rec)hCG
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG | Cycle 1 (n=658) | 400.0 International Unit (IU) |
| Corifollitropin Alfa 150 µg | Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG | Cycle 2 (n=364) | 450.0 International Unit (IU) |
| Corifollitropin Alfa 150 µg | Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG | Cycle 3 (n=190) | 450.0 International Unit (IU) |
Secondary
Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy
The ongoing pregnancy rate, cumulative over the entire study (in percent), is defined as 100 times the number of participants who had an ongoing pregnancy in Treatment Cycles 1, 2 or 3, or in any FTET cycle, or who had a spontaneous ongoing pregnancy, divided by the total number of participants who were administered corifollitropin alfa in the study. A participant could only be represented once in the count of ongoing pregnancies for determination of cumulative ongoing pregnancy rate. After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. A spontaneous pregnancy is a pregnancy that was not considered to have resulted from ET in a treatment cycle or FTET cycle.
Time frame: Up to approximately 26 months after first dose of corifollitropin alfa
Population: Participants who received corifollitropin alfa
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa 150 µg | Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy | 50.6 percentage of participants |
Secondary
Fertilization Rate
The fertilization rate (in percent) is defined as 100 times the ratio of the number of fertilized 2 PN oocytes obtained and the number of oocytes that was used for fertilization, per participant.
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Fertilization Rate | Cycle 3 (n=188) | 67.3 percentage of oocytes | Standard Deviation 23.4 |
| Corifollitropin Alfa 150 µg | Fertilization Rate | Cycle 1 (n=649) | 67.0 percentage of oocytes | Standard Deviation 26.6 |
| Corifollitropin Alfa 150 µg | Fertilization Rate | Cycle 2 (n=359) | 66.0 percentage of oocytes | Standard Deviation 25.8 |
Secondary
Implantation Rate for Participants With ET
The implantation rate (in percent) is defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan after ET divided by the number of embryos transferred per participant.
Time frame: Approximately 5-6 weeks after ET, within a treatment cycle
Population: Participants who received corifollitropin alfa and had ET
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Implantation Rate for Participants With ET | Cycle 3 (n=178) | 16.3 percentage of embryos | Standard Deviation 30 |
| Corifollitropin Alfa 150 µg | Implantation Rate for Participants With ET | Cycle 1 (n=616) | 21.2 percentage of embryos | Standard Deviation 36.2 |
| Corifollitropin Alfa 150 µg | Implantation Rate for Participants With ET | Cycle 2 (n=340) | 16.6 percentage of embryos | Standard Deviation 31 |
Secondary
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1
At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality.
Time frame: Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 | Total obtained | 6.4 number of embryos | Standard Deviation 4.5 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 | Good quality (Grade 1 + 2) | 3.2 number of embryos | Standard Deviation 3.1 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 | Grade 1 | 1.2 number of embryos | Standard Deviation 2.1 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 | Grade 2 | 1.9 number of embryos | Standard Deviation 2.3 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 | Grade 3 | 2.3 number of embryos | Standard Deviation 2.5 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1 | Other grade | 1.0 number of embryos | Standard Deviation 2.1 |
Secondary
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2
At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality.
Time frame: Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 | Grade 3 | 2.4 number of embryos | Standard Deviation 2.7 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 | Total obtained | 6.5 number of embryos | Standard Deviation 4.4 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 | Good quality (Grade 1 + 2) | 2.9 number of embryos | Standard Deviation 2.8 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 | Grade 1 | 1.2 number of embryos | Standard Deviation 1.9 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 | Grade 2 | 1.8 number of embryos | Standard Deviation 2 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2 | Other grade | 1.2 number of embryos | Standard Deviation 2.4 |
Secondary
Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3
At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality.
Time frame: Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 | Good quality (Grade 1 + 2) | 2.8 number of embryos | Standard Deviation 2.7 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 | Grade 3 | 2.6 number of embryos | Standard Deviation 3 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 | Total obtained | 6.6 number of embryos | Standard Deviation 4.8 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 | Grade 1 | 1.0 number of embryos | Standard Deviation 1.9 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 | Grade 2 | 1.8 number of embryos | Standard Deviation 2 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3 | Other grade | 1.1 number of embryos | Standard Deviation 2.2 |
Secondary
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1
The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality.
Time frame: Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Population: Participants who received corifollitropin alfa in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 | Total frozen | 1.6 number of embryos | Standard Deviation 2.7 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 | Grade 2 | 0.8 number of embryos | Standard Deviation 1.7 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 | Good quality (Grade 1 + 2) | 1.2 number of embryos | Standard Deviation 2.3 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 | Grade 1 | 0.4 number of embryos | Standard Deviation 1.2 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 | Grade 3 | 0.4 number of embryos | Standard Deviation 1 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1 | Other grade | 0.1 number of embryos | Standard Deviation 0.4 |
Secondary
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2
The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality.
Time frame: Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Population: Participants who received corifollitropin alfa in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 | Total frozen | 1.1 number of embryos | Standard Deviation 2.1 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 | Good quality (Grade 1 + 2) | 0.8 number of embryos | Standard Deviation 1.7 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 | Grade 1 | 0.3 number of embryos | Standard Deviation 1 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 | Grade 2 | 0.5 number of embryos | Standard Deviation 1.3 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 | Grade 3 | 0.3 number of embryos | Standard Deviation 0.9 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2 | Other grade | 0.0 number of embryos | Standard Deviation 0.4 |
Secondary
Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3
The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality.
Time frame: Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Population: Participants who received corifollitropin alfa in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 | Good quality (Grade 1 + 2) | 0.8 number of embryos | Standard Deviation 1.7 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 | Total frozen | 1.1 number of embryos | Standard Deviation 2.2 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 | Grade 1 | 0.3 number of embryos | Standard Deviation 1.1 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 | Grade 2 | 0.5 number of embryos | Standard Deviation 1.3 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 | Grade 3 | 0.3 number of embryos | Standard Deviation 1 |
| Corifollitropin Alfa 150 µg | Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3 | Other grade | 0.0 number of embryos | Standard Deviation 0.4 |
Secondary
Number of Embryos Transferred
ET is the procedure in which one or more embryos are placed in the uterus. The number of embryos transferred, per participant, is summarized.
Time frame: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle
Population: Participants who received corifollitropin alfa and had ET
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Embryos Transferred | Cycle 1 (n=616) | 1.9 number of embryos | Standard Deviation 0.7 |
| Corifollitropin Alfa 150 µg | Number of Embryos Transferred | Cycle 2 (n=340) | 2.1 number of embryos | Standard Deviation 0.7 |
| Corifollitropin Alfa 150 µg | Number of Embryos Transferred | Cycle 3 (n=178) | 2.2 number of embryos | Standard Deviation 0.7 |
Secondary
Number of Fertilized Oocytes Obtained in Treatment Cycle 1
This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of pronuclei (PN) present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 1 | ≥3 PN fertilized oocytes | 0.3 number of fertilized oocytes | Standard Deviation 0.7 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 1 | 0 PN fertilized oocytes | 2.2 number of fertilized oocytes | Standard Deviation 2.9 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 1 | 1 PN fertilized oocytes | 0.2 number of fertilized oocytes | Standard Deviation 0.6 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 1 | 2 PN fertilized oocytes | 6.1 number of fertilized oocytes | Standard Deviation 4 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 1 | Other fertilized oocytes | 0.7 number of fertilized oocytes | Standard Deviation 1.6 |
Secondary
Number of Fertilized Oocytes Obtained in Treatment Cycle 2
This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 2 | 0 PN fertilized oocytes | 2.1 number of fertilized oocytes | Standard Deviation 2.5 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 2 | 1 PN fertilized oocytes | 0.3 number of fertilized oocytes | Standard Deviation 0.9 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 2 | 2 PN fertilized oocytes | 6.1 number of fertilized oocytes | Standard Deviation 4 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 2 | ≥3 PN fertilized oocytes | 0.3 number of fertilized oocytes | Standard Deviation 0.7 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 2 | Other fertilized oocytes | 0.6 number of fertilized oocytes | Standard Deviation 1.2 |
Secondary
Number of Fertilized Oocytes Obtained in Treatment Cycle 3
This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 3 | 0 PN fertilized oocytes | 1.8 number of fertilized oocytes | Standard Deviation 2.3 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 3 | 1 PN fertilized oocytes | 0.2 number of fertilized oocytes | Standard Deviation 0.5 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 3 | 2 PN fertilized oocytes | 6.2 number of fertilized oocytes | Standard Deviation 4.2 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 3 | ≥3 PN fertilized oocytes | 0.3 number of fertilized oocytes | Standard Deviation 0.7 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained in Treatment Cycle 3 | Other fertilized oocytes | 0.8 number of fertilized oocytes | Standard Deviation 1.6 |
Secondary
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1
This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1, and were enrolled at a site using cyropreservation at the fertilized oocyte level
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 | Other fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 | 0 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 | 1 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0.1 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 | 2 PN fertilized oocytes | 1.9 number of fertilized oocytes | Standard Deviation 3.2 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1 | ≥3 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
Secondary
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2
This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2, and were enrolled at a site using cyropreservation at the fertilized oocyte level
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 | 0 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 | 1 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 | 2 PN fertilized oocytes | 1.6 number of fertilized oocytes | Standard Deviation 3.3 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 | ≥3 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2 | Other fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
Secondary
Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3
This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3, and were enrolled at a site using cyropreservation at the fertilized oocyte level
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 | 0 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 | 1 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 | 2 PN fertilized oocytes | 1.1 number of fertilized oocytes | Standard Deviation 2.1 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 | ≥3 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3 | Other fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
Secondary
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1
This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 | 0 PN fertilized oocytes | 0.6 number of fertilized oocytes | Standard Deviation 1.9 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 | 1 PN fertilized oocytes | 0.1 number of fertilized oocytes | Standard Deviation 0.3 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 | 2 PN fertilized oocytes | 5.7 number of fertilized oocytes | Standard Deviation 4.1 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 | ≥3 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1 | Other fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0.1 |
Secondary
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2
This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 | 0 PN fertilized oocytes | 0.6 number of fertilized oocytes | Standard Deviation 1.8 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 | 1 PN fertilized oocytes | 0.1 number of fertilized oocytes | Standard Deviation 0.8 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 | 2 PN fertilized oocytes | 5.8 number of fertilized oocytes | Standard Deviation 3.9 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 | ≥3 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2 | Other fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0.2 |
Secondary
Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3
This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).
Time frame: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 | 0 PN fertilized oocytes | 0.5 number of fertilized oocytes | Standard Deviation 1.6 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 | 1 PN fertilized oocytes | 0.1 number of fertilized oocytes | Standard Deviation 0.4 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 | 2 PN fertilized oocytes | 6.0 number of fertilized oocytes | Standard Deviation 4.2 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 | ≥3 PN fertilized oocytes | 0.0 number of fertilized oocytes | Standard Deviation 0.1 |
| Corifollitropin Alfa 150 µg | Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3 | Other fertilized oocytes | 0.1 number of fertilized oocytes | Standard Deviation 0.6 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.
Time frame: Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1 | follicles ≥17 mm | 5.4 follicles | Standard Deviation 2.8 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1 | follicles ≥11 mm | 14.5 follicles | Standard Deviation 6.4 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1 | follicles ≥15 mm | 9.2 follicles | Standard Deviation 4.3 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.
Time frame: Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2 | follicles ≥11 mm | 13.9 follicles | Standard Deviation 6 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2 | follicles ≥15 mm | 9.0 follicles | Standard Deviation 3.9 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2 | follicles ≥17 mm | 5.4 follicles | Standard Deviation 2.7 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.
Time frame: Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3 | follicles ≥11 mm | 13.7 follicles | Standard Deviation 6.4 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3 | follicles ≥15 mm | 9.0 follicles | Standard Deviation 4.7 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3 | follicles ≥17 mm | 5.4 follicles | Standard Deviation 2.9 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time frame: Stimulation Day 1 in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1 | follicles ≥11 mm | 0.0 follicles | Standard Deviation 0.1 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1 | follicles ≥15 mm | 0.0 follicles | Standard Deviation 0.1 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1 | follicles ≥17 mm | 0.0 follicles | Standard Deviation 0.1 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time frame: Stimulation Day 1 in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2 | follicles ≥11 mm | 0.0 follicles | Standard Deviation 0.3 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2 | follicles ≥15 mm | 0.0 follicles | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2 | follicles ≥17 mm | 0.0 follicles | Standard Deviation 0 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time frame: Stimulation Day 1 in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3 | follicles ≥11 mm | 0.0 follicles | Standard Deviation 0.2 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3 | follicles ≥15 mm | 0.0 follicles | Standard Deviation 0 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3 | follicles ≥17 mm | 0.0 follicles | Standard Deviation 0 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time frame: Stimulation Day 5 or 6 in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1 | follicles ≥11 mm | 5.1 follicles | Standard Deviation 4.2 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1 | follicles ≥15 mm | 0.4 follicles | Standard Deviation 1 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1 | follicles ≥17 mm | 0.1 follicles | Standard Deviation 0.3 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time frame: Stimulation Day 5 or 6 in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2 | follicles ≥11 mm | 4.8 follicles | Standard Deviation 4.1 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2 | follicles ≥15 mm | 0.4 follicles | Standard Deviation 1 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2 | follicles ≥17 mm | 0.1 follicles | Standard Deviation 0.4 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time frame: Stimulation Day 5 or 6 in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3 | follicles ≥11 mm | 4.0 follicles | Standard Deviation 3.3 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3 | follicles ≥15 mm | 0.3 follicles | Standard Deviation 0.9 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3 | follicles ≥17 mm | 0.0 follicles | Standard Deviation 0.3 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time frame: Stimulation Day 8 in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1 | follicles ≥15 mm | 3.7 follicles | Standard Deviation 3.3 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1 | follicles ≥11 mm | 11.1 follicles | Standard Deviation 5.9 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1 | follicles ≥17 mm | 1.1 follicles | Standard Deviation 1.8 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time frame: Stimulation Day 8 in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2 | follicles ≥11 mm | 10.7 follicles | Standard Deviation 5.4 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2 | follicles ≥15 mm | 3.6 follicles | Standard Deviation 3.3 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2 | follicles ≥17 mm | 1.2 follicles | Standard Deviation 1.8 |
Secondary
Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3
For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.
Time frame: Stimulation Day 8 in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3 | follicles ≥11 mm | 10.0 follicles | Standard Deviation 5.8 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3 | follicles ≥15 mm | 3.4 follicles | Standard Deviation 3.3 |
| Corifollitropin Alfa 150 µg | Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3 | follicles ≥17 mm | 1.1 follicles | Standard Deviation 1.8 |
Secondary
Number of Oocytes Retrieved in a Participant Among Entire Study Population
Oocyte retrieval, also known as oocyte pick-up, is a technique used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The number of oocytes retrieved, per participant, is summarized.
Time frame: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle
Population: Participants who received corifollitropin alfa
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Oocytes Retrieved in a Participant Among Entire Study Population | Cycle 2 (n=375) | 11.5 number of oocytes | Standard Deviation 6.8 |
| Corifollitropin Alfa 150 µg | Number of Oocytes Retrieved in a Participant Among Entire Study Population | Cycle 3 (n=198) | 11.3 number of oocytes | Standard Deviation 7.6 |
| Corifollitropin Alfa 150 µg | Number of Oocytes Retrieved in a Participant Among Entire Study Population | Cycle 1 (n=682) | 11.9 number of oocytes | Standard Deviation 7.2 |
Secondary
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1
The number of embryos transferred, for each participant, by category of number of good quality embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality.
Time frame: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and had ET in Treatment Cycle 1
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 | With 0 good quality embryos transferred | 110 participants | 4.5 |
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 | With 1 good quality embryo transferred | 230 participants | 3.1 |
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 | With 2 good quality embryos transferred | 201 participants | 2.1 |
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1 | With 3 good quality embryos transferred | 75 participants | 2.3 |
Secondary
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2
The number of embryos transferred, for each participant, by category of number of good quality embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality.
Time frame: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and had ET in Treatment Cycle 2
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 | With 0 good quality embryos transferred | 81 participants | 4.5 |
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 | With 1 good quality embryo transferred | 80 participants | 3.1 |
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 | With 2 good quality embryos transferred | 122 participants | 2.1 |
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2 | With 3 good quality embryos transferred | 57 participants | 2.3 |
Secondary
Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3
The number of embryos transferred, for each participant, by category of number of good quality embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or other grade, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of good quality.
Time frame: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and had ET in Treatment Cycle 3
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 | With 0 good quality embryos transferred | 31 participants | 4.5 |
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 | With 1 good quality embryo transferred | 49 participants | 3.1 |
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 | With 2 good quality embryos transferred | 65 participants | 2.1 |
| Corifollitropin Alfa 150 µg | Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3 | With 3 good quality embryos transferred | 33 participants | 2.3 |
Secondary
Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3
Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.
Time frame: ≥14 days (for biochemical pregnancy), 5-6 weeks (for clinical pregnancy), 5-6 weeks to 10 weeks (for vital pregnancy) and 10 weeks up to 9 months (for ongoing pregnancy) after ET, within a treatment cycle
Population: Participants who received corifollitropin alfa
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 | Vital pregnancy | 278 participants |
| Corifollitropin Alfa 150 µg | Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 | Biochemical pregnancy | 340 participants |
| Corifollitropin Alfa 150 µg | Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 | Clinical pregnancy | 303 participants |
| Corifollitropin Alfa 150 µg | Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 | Ongoing pregnancy | 272 participants |
Secondary
Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3
Ectopic pregnancy: A pregnancy in which the embryo attaches itself in a place other than inside the uterus. The most common site for an ectopic pregnancy is within one of the two fallopian tubes. Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy.
Time frame: From 2 weeks up to approximately 5-6 weeks after ET, within a treatment cycle
Population: Participants who received corifollitropin alfa and had biochemical pregnancy in any of Treatment Cycles 1, 2 or 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3 | 9 participants |
Secondary
Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3
Miscarriage: Loss of the fetus without induction or instrumentation, also known as spontaneous abortion. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan.
Time frame: 5-6 weeks up to 9 months after ET, within a treatment cycle
Population: Participants who received corifollitropin alfa and had clinical pregnancy in any of Treatment Cycles 1, 2 or 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3 | 37 participants |
Secondary
Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3
Miscarriage: Loss of the fetus without induction or instrumentation, also known as spontaneous abortion. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan.
Time frame: 5-6 weeks up to 9 months after ET, within a treatment cycle
Population: Participants who received corifollitropin alfa and had vital pregnancy in any of Treatment Cycles 1, 2 or 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3 | 5 participants |
Secondary
Number of Participants With Ongoing Pregnancy in Any FTET Cycle
After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. This measure summarizes the number of participants with ongoing pregnancy following ET within an FTET cycle. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.
Time frame: 10 weeks up to 9 months after ET within an FTET cycle
Population: Participants who received corifollitropin alfa and had ET in any FTET cycle
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants With Ongoing Pregnancy in Any FTET Cycle | 48 participants |
Secondary
Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3
Singleton pregnancy is a pregnancy in which one fetus develops in the uterus. Multiple pregnancy is a pregnancy in which more than one fetus develops simultaneously in the uterus. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.
Time frame: 10 weeks up to 9 months after ET, within a treatment cycle
Population: Participants who received corifollitropin alfa and had ongoing pregnancy in any of Treatment Cycles 1, 2 or 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corifollitropin Alfa 150 µg | Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 | Singleton ongoing pregnancy | 226 participants |
| Corifollitropin Alfa 150 µg | Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3 | Multiple ongoing pregnancy | 46 participants |
Secondary
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1
This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 1. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.
Time frame: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 | Oocytes assessed | 12.2 number of oocytes | Standard Deviation 7 |
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 | Metaphase I | 0.8 number of oocytes | Standard Deviation 1.4 |
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 | Metaphase II | 9.8 number of oocytes | Standard Deviation 6 |
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1 | Germinal vesicles stage | 0.9 number of oocytes | Standard Deviation 1.4 |
Secondary
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2
This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 2. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.
Time frame: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 | Oocytes assessed | 11.6 number of oocytes | Standard Deviation 6.5 |
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 | Metaphase I | 0.9 number of oocytes | Standard Deviation 1.5 |
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 | Metaphase II | 9.3 number of oocytes | Standard Deviation 5.4 |
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2 | Germinal vesicles stage | 0.8 number of oocytes | Standard Deviation 1.4 |
Secondary
Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3
This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 3. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.
Time frame: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 | Oocytes assessed | 11.3 number of oocytes | Standard Deviation 6.3 |
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 | Metaphase I | 0.8 number of oocytes | Standard Deviation 1.3 |
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 | Metaphase II | 9.1 number of oocytes | Standard Deviation 5.2 |
| Corifollitropin Alfa 150 µg | Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3 | Germinal vesicles stage | 0.9 number of oocytes | Standard Deviation 1.5 |
Secondary
Serum Estradiol Levels in Treatment Cycle 1
Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 1 | Stimulation Day 1 (pre-dose) (n=651) | 126.07 pmol/L | Standard Deviation 74.36 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 1 | Stimulation Day 5 or 6 (n=648) | 2246.72 pmol/L | Standard Deviation 1479.01 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 1 | Stimulation Day 8 (n=633) | 3224.72 pmol/L | Standard Deviation 2013.62 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 1 | Day of (rec)hCG injection (n=642) | 5602.90 pmol/L | Standard Deviation 3400.47 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 1 | Day of embryo transfer (n=593) | 2972.22 pmol/L | Standard Deviation 1758.83 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 1 | 2 weeks after embryo transfer (n=611) | 1064.92 pmol/L | Standard Deviation 2006.31 |
Secondary
Serum Estradiol Levels in Treatment Cycle 2
Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 2 | 2 weeks after embryo transfer (n=333) | 929.24 pmol/L | Standard Deviation 1861.04 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 2 | Stimulation Day 1 (pre-dose) (n=357) | 120.80 pmol/L | Standard Deviation 43.73 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 2 | Stimulation Day 5 or 6 (n=357) | 2116.13 pmol/L | Standard Deviation 1362.31 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 2 | Stimulation Day 8 (n=346) | 3197.12 pmol/L | Standard Deviation 2098.53 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 2 | Day of (rec)hCG injection (n=358) | 5444.89 pmol/L | Standard Deviation 2992.37 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 2 | Day of embryo transfer (n=324) | 2988.11 pmol/L | Standard Deviation 1823.81 |
Secondary
Serum Estradiol Levels in Treatment Cycle 3
Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 3 | Stimulation Day 1 (pre-dose) (n=185) | 117.5 pmol/L | Standard Deviation 42.1 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 3 | Stimulation Day 5 or 6 (n=185) | 1993.66 pmol/L | Standard Deviation 1372.67 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 3 | Stimulation Day 8 (n=184) | 3164.08 pmol/L | Standard Deviation 2214.33 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 3 | Day of (rec)hCG injection (n=183) | 5605.89 pmol/L | Standard Deviation 3687.99 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 3 | Day of embryo transfer (n=168) | 3065.47 pmol/L | Standard Deviation 1988.36 |
| Corifollitropin Alfa 150 µg | Serum Estradiol Levels in Treatment Cycle 3 | 2 weeks after embryo transfer (n=172) | 746.52 pmol/L | Standard Deviation 1249.66 |
Secondary
Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1
Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 | Stimulation Day 1 (pre-dose) (n=651) | 7.18 International Units (IU)/L | Standard Deviation 2.34 |
| Corifollitropin Alfa 150 µg | Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 | Stimulation Day 5 or 6 (n=648) | 24.00 International Units (IU)/L | Standard Deviation 6.36 |
| Corifollitropin Alfa 150 µg | Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 | 2 weeks after embryo transfer (n=611) | 4.84 International Units (IU)/L | Standard Deviation 3.51 |
| Corifollitropin Alfa 150 µg | Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 | Stimulation Day 8 (n=634) | 13.23 International Units (IU)/L | Standard Deviation 3.4 |
| Corifollitropin Alfa 150 µg | Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 | Day of (rec)hCG injection (n=643) | 13.63 International Units (IU)/L | Standard Deviation 3.69 |
| Corifollitropin Alfa 150 µg | Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1 | Day of embryo transfer (n=593) | 3.21 International Units (IU)/L | Standard Deviation 1.68 |
Secondary
Serum FSH Levels in Treatment Cycle 2
Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 2 | Stimulation Day 1 (pre-dose) (n=357) | 7.17 IU/L | Standard Deviation 2.17 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 2 | Stimulation Day 5 or 6 (n=358) | 24.24 IU/L | Standard Deviation 5.75 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 2 | Stimulation Day 8 (n=346) | 13.38 IU/L | Standard Deviation 3.35 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 2 | Day of (rec)hCG injection (n=358) | 13.78 IU/L | Standard Deviation 3.74 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 2 | Day of embryo transfer (n=326) | 3.20 IU/L | Standard Deviation 1.45 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 2 | 2 weeks after embryo transfer (n=333) | 5.07 IU/L | Standard Deviation 3.33 |
Secondary
Serum FSH Levels in Treatment Cycle 3
Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 3 | Stimulation Day 1 (pre-dose) (n=185) | 7.50 IU/L | Standard Deviation 5.24 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 3 | Stimulation Day 5 or 6 (n=186) | 24.51 IU/L | Standard Deviation 5.93 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 3 | Stimulation Day 8 (n=184) | 13.56 IU/L | Standard Deviation 3.35 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 3 | Day of (rec)hCG injection (n=183) | 13.62 IU/L | Standard Deviation 3.49 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 3 | Day of embryo transfer (n=168) | 3.17 IU/L | Standard Deviation 1.55 |
| Corifollitropin Alfa 150 µg | Serum FSH Levels in Treatment Cycle 3 | 2 weeks after embryo transfer (n=173) | 5.01 IU/L | Standard Deviation 3.4 |
Secondary
Serum Inhibin-B Levels in Treatment Cycle 1
Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 1 | Stimulation Day 1 (pre-dose) (n=652) | 48.22 pg/mL | Standard Deviation 29.91 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 1 | Stimulation Day 5 or 6 (n=648) | 409.63 pg/mL | Standard Deviation 299.19 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 1 | Stimulation Day 8 (n=634) | 455.46 pg/mL | Standard Deviation 372.09 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 1 | Day of (rec)hCG injection (n=643) | 523.07 pg/mL | Standard Deviation 464.36 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 1 | Day of embryo transfer (n=591) | NA pg/mL | — |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 1 | 2 weeks after embryo transfer (n=611) | NA pg/mL | — |
Secondary
Serum Inhibin-B Levels in Treatment Cycle 2
Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 2 | Stimulation Day 1 (pre-dose) (n=356) | 48.88 pg/mL | Standard Deviation 26.79 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 2 | Stimulation Day 5 or 6 (n=358) | 406.29 pg/mL | Standard Deviation 326.64 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 2 | Stimulation Day 8 (n=346) | 443.32 pg/mL | Standard Deviation 402.67 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 2 | Day of (rec)hCG injection (n=358) | 505.02 pg/mL | Standard Deviation 432.96 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 2 | Day of embryo transfer (n=325) | 29.38 pg/mL | Standard Deviation 34.99 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 2 | 2 weeks after embryo transfer (n=333) | 39.04 pg/mL | Standard Deviation 33.74 |
Secondary
Serum Inhibin-B Levels in Treatment Cycle 3
Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 3 | Stimulation Day 1 (pre-dose) (n=185) | 50.49 pg/mL | Standard Deviation 28.25 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 3 | Stimulation Day 5 or 6 (n=186) | 406.14 pg/mL | Standard Deviation 331.91 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 3 | Stimulation Day 8 (n=184) | 439.83 pg/mL | Standard Deviation 374.99 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 3 | Day of (rec)hCG injection (n=183) | 504.03 pg/mL | Standard Deviation 437.68 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 3 | Day of embryo transfer (n=168) | 26.28 pg/mL | Standard Deviation 25.03 |
| Corifollitropin Alfa 150 µg | Serum Inhibin-B Levels in Treatment Cycle 3 | 2 weeks after embryo transfer (n=173) | 40.16 pg/mL | Standard Deviation 34.05 |
Secondary
Serum LH Levels in Treatment Cycle 2
Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 2 | 2 weeks after embryo transfer (n=333) | 3.41 IU/L | Standard Deviation 2.48 |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 2 | Stimulation Day 1 (pre-dose) (n=357) | 5.13 IU/L | Standard Deviation 1.86 |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 2 | Stimulation Day 5 or 6 (n=358) | 4.78 IU/L | Standard Deviation 5.18 |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 2 | Stimulation Day 8 (n=346) | 1.35 IU/L | Standard Deviation 1.77 |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 2 | Day of (rec)hCG injection (n=358) | 1.67 IU/L | Standard Deviation 2.15 |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 2 | Day of embryo transfer (n=326) | NA IU/L | — |
Secondary
Serum LH Levels in Treatment Cycle 3
Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 3 | Stimulation Day 1 (pre-dose) (n=185) | 5.05 IU/L | Standard Deviation 1.97 |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 3 | Stimulation Day 5 or 6 (n=186) | 4.84 IU/L | Standard Deviation 5.39 |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 3 | Stimulation Day 8 (n=184) | 1.36 IU/L | Standard Deviation 1.5 |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 3 | Day of (rec)hCG injection (n=183) | 1.79 IU/L | Standard Deviation 2.71 |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 3 | Day of embryo transfer (n=168) | NA IU/L | — |
| Corifollitropin Alfa 150 µg | Serum LH Levels in Treatment Cycle 3 | 2 weeks after embryo transfer (n=173) | 3.57 IU/L | Standard Deviation 3.13 |
Secondary
Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1
Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 | Day of embryo transfer (n=593) | NA IU/L | — |
| Corifollitropin Alfa 150 µg | Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 | Stimulation Day 1 (pre-dose) (n=651) | 5.07 IU/L | Standard Deviation 1.86 |
| Corifollitropin Alfa 150 µg | Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 | Stimulation Day 5 or 6 (n=648) | 4.86 IU/L | Standard Deviation 5.39 |
| Corifollitropin Alfa 150 µg | Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 | Stimulation Day 8 (n=634) | 1.34 IU/L | Standard Deviation 1.55 |
| Corifollitropin Alfa 150 µg | Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 | Day of (rec)hCG injection (n=643) | 1.53 IU/L | Standard Deviation 1.98 |
| Corifollitropin Alfa 150 µg | Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1 | 2 weeks after embryo transfer (n=611) | 3.27 IU/L | Standard Deviation 2.57 |
Secondary
Serum Progesterone Levels in Treatment Cycle 1
Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 1 | Stimulation Day 1 (pre-dose) (n=651) | 1.99 nmol/L | Standard Deviation 2.4 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 1 | Stimulation Day 5 or 6 (n=648) | 2.72 nmol/L | Standard Deviation 11.85 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 1 | Stimulation Day 8 (n=633) | 1.85 nmol/L | Standard Deviation 2 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 1 | Day of (rec)hCG injection (n=643) | 4.14 nmol/L | Standard Deviation 23.37 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 1 | Day of embryo transfer (n=593) | 331.16 nmol/L | Standard Deviation 169.05 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 1 | 2 weeks after embryo transfer (n=611) | 100.31 nmol/L | Standard Deviation 168.53 |
Secondary
Serum Progesterone Levels in Treatment Cycle 2
Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 2 | Stimulation Day 1 (pre-dose) (n=357) | 1.84 nmol/L | Standard Deviation 1.64 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 2 | Stimulation Day 5 or 6 (n=358) | 2.14 nmol/L | Standard Deviation 1.13 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 2 | Stimulation Day 8 (n=346) | 1.75 nmol/L | Standard Deviation 1.09 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 2 | Day of (rec)hCG injection (n=358) | 3.91 nmol/L | Standard Deviation 9.14 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 2 | Day of embryo transfer (n=325) | 316.28 nmol/L | Standard Deviation 174.25 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 2 | 2 weeks after embryo transfer (n=333) | 88.21 nmol/L | Standard Deviation 165.39 |
Secondary
Serum Progesterone Levels in Treatment Cycle 3
Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.
Time frame: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3
Population: Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 3 | Stimulation Day 1 (pre-dose) (n=185) | 1.76 nmol/L | Standard Deviation 0.74 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 3 | Stimulation Day 5 or 6 (n=186) | 2.29 nmol/L | Standard Deviation 3.37 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 3 | Stimulation Day 8 (n=184) | 1.75 nmol/L | Standard Deviation 0.74 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 3 | Day of (rec)hCG injection (n=183) | 4.92 nmol/L | Standard Deviation 14.81 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 3 | Day of embryo transfer (n=168) | 311.64 nmol/L | Standard Deviation 161.71 |
| Corifollitropin Alfa 150 µg | Serum Progesterone Levels in Treatment Cycle 3 | 2 weeks after embryo transfer (n=173) | 79.03 nmol/L | Standard Deviation 136.6 |