In Vitro Fertilization
Conditions
Keywords
Infertility, Pharmacological effect of drugs, Hormones, Hormone substitutes and hormone antagonists, Pharmacological actions, Randomized, Multi-center, Multi-national, Double-blind, Active-controlled, Non-inferiority
Brief summary
To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.
Detailed description
This is a randomized, double-blind, active-controlled, non-inferiority clinical trial investigating the efficacy and safety of a new treatment regimen with Corifollitropin Alfa, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in controlled ovarian stimulation for Assisted Reproductive Technology (ART). For this regimen, participants receive a single injection of Corifollitropin Alfa and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group participants receive daily injections of recFSH up to the day of triggering final oocyte maturation. Non-inferiority in ongoing pregnancy rates (assessed at least 10 weeks after embryo transfer) will be the primary endpoint for this trial. The number of oocytes retrieved will be analyzed as co-primary endpoint.
Interventions
DRUGCorifollitropin alfa
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.
BIOLOGICALRecFSH / Follitropin beta (Days 1 to 7)
Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
DRUGPlacebo Corifollitropin alfa
Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
DRUGPlacebo RecFSH / follitropin beta
Identical ready-for-use solution, but without the active ingedient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
BIOLOGICALRecFSH / Follitropin beta (Days 8 to hCG)
From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
DRUGGanirelix
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
BIOLOGICALhCG
When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
BIOLOGICALProgesterone
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
Inclusion criteria
* Females of couples with an indication for Controlled Ovarian Stimulation (COS) and in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI); * \>=18 and \<=36 years of age at the time of signing informed consent; * Body weight \> 60 and \<=90 kg and body mass index (BMI) \>=18 and \<=32 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 ovarian hyperstimulation syndrome (OHSS); * History of/or current polycystic ovary syndrome (PCOS); * More than 20 basal antral follicles \<11 mm (both ovaries combined) as measured on ultrasound scan (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 hydrosalphinx (visible on USS); * Presence of any clinically relevant pathology affecting the uterine cavity or fibroids \>=5 cm; * More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable); * History of non- or low ovarian response to FSH/ human menopausal gonadotropin (hMG) treatment; * History of recurrent miscarriage (3 or more, even when unexplained); * FSH \> 12 IU/L or 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; * Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts); * Recent history of/or current epilepsy, human immunodeficiency virus (HIV) infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease; * Abnormal karyotyping of the patient or her partner (if karyotyping is performed); * Smoking more than 5 cigarettes per day; * History or presence of alcohol or drug abuse within 12 months prior to signing informed consent; * Previous use of Org 36286; * Use of hormonal preparations within 1 month prior to randomization; * Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol; * Administration of investigational drugs within three months prior to signing informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Oocytes Retrieved | Up to 36 hours after administration of hCG (up to 1 year) | Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed. |
| Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) | Assessed at least 10 weeks after embryo transfer (up to 1 year) | An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum FSH Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment. |
| Serum Luteinizing Hormone (LH) Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment. |
| Serum Estradiol (E2) Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment. |
| Serum Progesterone (P) Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment |
| Serum Inhibin-B Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment |
| Number of Follicles Categorized by Size on Stimulation Day 1 | On Day 1 of treatment (up to 1 year) | Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size. |
| Number of Follicles Categorized by Size on Stimulation Day 5 | On Day 5 of treatment (up to 1 year) | Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size. |
| Number of Follicles Categorized by Size on Stimulation Day 8 | On Day 8 of treatment (up to 1 year) | Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size. |
| Number of Follicles Categorized by Size on the Day of hCG | Day of HCG treatment (up to 1 year) | Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size. |
| Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1 | From Day 1 to day of hCG treatment (up to 1 year) | The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 1 onwards. |
| Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) | Up to 36 hours after administration of hCG (up to 1 year) | The number of oocytes used for ICSI was assessed, and categorized based on their quality |
| Percentage of Fertilized Oocytes (Fertilization Rate) | Up to 18 hours after start of fertilization (up to 1 year) | The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI |
| Number of Embryos Obtained on Day 3 Categorized by Quality | Post fertilization Day 3 (up to 1 year) | Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: \< 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality. |
| Number of Embryos Transferred on Day 3 | Post fertilization Day 3 (up to 1 year) | After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: \< 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. |
| Percentage of Gestational Sacs (Implantation Rate) | Up to 6 weeks after embryo transfer (up to 1 year) | The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred. |
| Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy | Up to day of miscarriage (up to 1 year) | The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth. |
| Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy | Up to day of miscarriage (up to 1 year) | The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity. |
| Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt | Two weeks after embryo transfer (up to 1 year) | Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed. |
| Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer | Two weeks after embryo transfer (up to 1 year) | Biochemical pregnancy was assessed for participants who had embryo transfer by measuring serum or urinary hCG. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed. |
| Number of Cumulus-oocyte-complexes | Up to 36 hours after administration of hCG (up to 1 year) | Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed |
| Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8 | From Day 8 to Day of hCG treatment (up to 1 year) | The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 8 onwards. |
Participant flow
Pre-assignment details
Of 1509 randomized participants, 1506 received treatment with either Corifollitropin Alfa or recFSH (Intent-to Treat population \[ITT\]).
Participants by arm
| Arm | Count |
|---|---|
| 150 µg Corifollitropin Alfa Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. | 756 |
| 200 IU recFSH Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. | 750 |
| Total | 1,506 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 16 | 3 |
| Overall Study | Insufficient compliance with medication | 2 | 1 |
| Overall Study | Insufficient ovarian response | 4 | 1 |
| Overall Study | Insufficient ovarian response on Day 8 | 4 | 1 |
| Overall Study | No/abnormal fertilization | 11 | 13 |
| Overall Study | No/too few/bad quality embryos | 24 | 18 |
| Overall Study | No/too few/bad quality oocytes | 4 | 3 |
| Overall Study | Not treated | 1 | 2 |
| Overall Study | Other Reasons | 5 | 3 |
| Overall Study | Risk Ovarian Hyperstimulation Syndrome | 8 | 2 |
| Overall Study | Too high ovarian response | 6 | 1 |
Baseline characteristics
| Characteristic | 150 µg Corifollitropin Alfa | 200 IU recFSH | Total |
|---|---|---|---|
| Age, Continuous | 31.5 Years STANDARD_DEVIATION 3.3 | 31.5 Years STANDARD_DEVIATION 3.2 | 31.5 Years STANDARD_DEVIATION 3.3 |
| Sex: Female, Male Female | 756 Participants | 750 Participants | 1506 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 403 / 755 | 383 / 751 |
| serious Total, serious adverse events | 35 / 755 | 30 / 751 |
Outcome results
Primary
Mean Number of Oocytes Retrieved
Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed.
Time frame: Up to 36 hours after administration of hCG (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 150 µg Corifollitropin Alfa | Mean Number of Oocytes Retrieved | 13.8 Number of oocytes | Standard Deviation 8.3 |
| 200 IU recFSH | Mean Number of Oocytes Retrieved | 12.6 Number of oocytes | Standard Deviation 6.8 |
p-value: 0.00195% CI: [0.5, 1.9]ANOVA
Primary
Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)
An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.
Time frame: Assessed at least 10 weeks after embryo transfer (up to 1 year)
Population: Intent to Treat (ITT) population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 150 µg Corifollitropin Alfa | Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) | 39.0 Percentage of participants |
| 200 IU recFSH | Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) | 38.1 Percentage of participants |
95% CI: [-3.8, 5.9]
Secondary
Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1
The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 1 onwards.
Time frame: From Day 1 to day of hCG treatment (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 150 µg Corifollitropin Alfa | Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1 | 400 IU |
| 200 IU recFSH | Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1 | 1800 IU |
Secondary
Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8
The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 8 onwards.
Time frame: From Day 8 to Day of hCG treatment (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 150 µg Corifollitropin Alfa | Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8 | 400 IU |
| 200 IU recFSH | Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8 | 400 IU |
Secondary
Number of Cumulus-oocyte-complexes
Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed
Time frame: Up to 36 hours after administration of hCG (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who underwent IVF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 150 µg Corifollitropin Alfa | Number of Cumulus-oocyte-complexes | 13.6 Number of cumulus-oocyte complexes | Standard Deviation 8.2 |
| 200 IU recFSH | Number of Cumulus-oocyte-complexes | 12.8 Number of cumulus-oocyte complexes | Standard Deviation 7 |
Secondary
Number of Embryos Obtained on Day 3 Categorized by Quality
Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: \< 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality.
Time frame: Post fertilization Day 3 (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with IVF and/or ICSI, and excludes those who had embryos transferred or cryopreserved before Day 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Number of Embryos Obtained on Day 3 Categorized by Quality | Total | 8.4 Number of embryos | Standard Deviation 5.5 |
| 150 µg Corifollitropin Alfa | Number of Embryos Obtained on Day 3 Categorized by Quality | Good Quality | 4.7 Number of embryos | Standard Deviation 4.3 |
| 150 µg Corifollitropin Alfa | Number of Embryos Obtained on Day 3 Categorized by Quality | Grade 1 | 2.6 Number of embryos | Standard Deviation 3.4 |
| 150 µg Corifollitropin Alfa | Number of Embryos Obtained on Day 3 Categorized by Quality | Grade 2 | 2.1 Number of embryos | Standard Deviation 2.5 |
| 150 µg Corifollitropin Alfa | Number of Embryos Obtained on Day 3 Categorized by Quality | Grade 3 | 2.4 Number of embryos | Standard Deviation 2.6 |
| 150 µg Corifollitropin Alfa | Number of Embryos Obtained on Day 3 Categorized by Quality | Other Grade | 1.4 Number of embryos | Standard Deviation 2.2 |
| 200 IU recFSH | Number of Embryos Obtained on Day 3 Categorized by Quality | Grade 3 | 2.0 Number of embryos | Standard Deviation 2.3 |
| 200 IU recFSH | Number of Embryos Obtained on Day 3 Categorized by Quality | Total | 7.5 Number of embryos | Standard Deviation 4.8 |
| 200 IU recFSH | Number of Embryos Obtained on Day 3 Categorized by Quality | Grade 2 | 2.0 Number of embryos | Standard Deviation 2.3 |
| 200 IU recFSH | Number of Embryos Obtained on Day 3 Categorized by Quality | Good Quality | 4.5 Number of embryos | Standard Deviation 3.9 |
| 200 IU recFSH | Number of Embryos Obtained on Day 3 Categorized by Quality | Other Grade | 1.1 Number of embryos | Standard Deviation 2.1 |
| 200 IU recFSH | Number of Embryos Obtained on Day 3 Categorized by Quality | Grade 1 | 2.5 Number of embryos | Standard Deviation 3.4 |
Secondary
Number of Embryos Transferred on Day 3
After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: \< 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account.
Time frame: Post fertilization Day 3 (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Number of Embryos Transferred on Day 3 | Total | 1.7 Number of embryos | Standard Deviation 0.4 |
| 150 µg Corifollitropin Alfa | Number of Embryos Transferred on Day 3 | Good Quality | 1.4 Number of embryos | Standard Deviation 0.7 |
| 200 IU recFSH | Number of Embryos Transferred on Day 3 | Total | 1.7 Number of embryos | Standard Deviation 0.4 |
| 200 IU recFSH | Number of Embryos Transferred on Day 3 | Good Quality | 1.4 Number of embryos | Standard Deviation 0.7 |
Secondary
Number of Follicles Categorized by Size on Stimulation Day 1
Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size.
Time frame: On Day 1 of treatment (up to 1 year)
Population: ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on Stimulation Day 1 | >=17 mm | 0.0 Number of follicles | Standard Deviation 0.2 |
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on Stimulation Day 1 | >=11 mm | 0.1 Number of follicles | Standard Deviation 0.3 |
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on Stimulation Day 1 | >=15 mm | 0.0 Number of follicles | Standard Deviation 0.2 |
| 200 IU recFSH | Number of Follicles Categorized by Size on Stimulation Day 1 | >=17 mm | 0.0 Number of follicles | Standard Deviation 0.2 |
| 200 IU recFSH | Number of Follicles Categorized by Size on Stimulation Day 1 | >=11 mm | 0.1 Number of follicles | Standard Deviation 0.4 |
| 200 IU recFSH | Number of Follicles Categorized by Size on Stimulation Day 1 | >=15 mm | 0.0 Number of follicles | Standard Deviation 0.2 |
Secondary
Number of Follicles Categorized by Size on Stimulation Day 5
Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.
Time frame: On Day 5 of treatment (up to 1 year)
Population: ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 5.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on Stimulation Day 5 | >=11 mm | 4.4 Number of follicles | Standard Deviation 3.8 |
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on Stimulation Day 5 | >=15 mm | 0.3 Number of follicles | Standard Deviation 0.7 |
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on Stimulation Day 5 | >=17 mm | 0.1 Number of follicles | Standard Deviation 0.3 |
| 200 IU recFSH | Number of Follicles Categorized by Size on Stimulation Day 5 | >=11 mm | 4.7 Number of follicles | Standard Deviation 3.9 |
| 200 IU recFSH | Number of Follicles Categorized by Size on Stimulation Day 5 | >=15 mm | 0.4 Number of follicles | Standard Deviation 0.9 |
| 200 IU recFSH | Number of Follicles Categorized by Size on Stimulation Day 5 | >=17 mm | 0.1 Number of follicles | Standard Deviation 0.4 |
Secondary
Number of Follicles Categorized by Size on Stimulation Day 8
Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.
Time frame: On Day 8 of treatment (up to 1 year)
Population: ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 8.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on Stimulation Day 8 | >=17 mm | 2.1 Number of follicles | Standard Deviation 2.9 |
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on Stimulation Day 8 | >=11 mm | 12.8 Number of follicles | Standard Deviation 6.7 |
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on Stimulation Day 8 | >=15 mm | 5.0 Number of follicles | Standard Deviation 4.6 |
| 200 IU recFSH | Number of Follicles Categorized by Size on Stimulation Day 8 | >=11 mm | 11.6 Number of follicles | Standard Deviation 6 |
| 200 IU recFSH | Number of Follicles Categorized by Size on Stimulation Day 8 | >=15 mm | 5.2 Number of follicles | Standard Deviation 4.1 |
| 200 IU recFSH | Number of Follicles Categorized by Size on Stimulation Day 8 | >=17 mm | 2.5 Number of follicles | Standard Deviation 2.8 |
Secondary
Number of Follicles Categorized by Size on the Day of hCG
Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.
Time frame: Day of HCG treatment (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection and with USS data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on the Day of hCG | >=11 mm | 16.0 Number of follicles | Standard Deviation 7 |
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on the Day of hCG | >=15 mm | 9.6 Number of follicles | Standard Deviation 4.8 |
| 150 µg Corifollitropin Alfa | Number of Follicles Categorized by Size on the Day of hCG | >=17 mm | 5.7 Number of follicles | Standard Deviation 3.2 |
| 200 IU recFSH | Number of Follicles Categorized by Size on the Day of hCG | >=11 mm | 13.9 Number of follicles | Standard Deviation 6.1 |
| 200 IU recFSH | Number of Follicles Categorized by Size on the Day of hCG | >=15 mm | 8.7 Number of follicles | Standard Deviation 4 |
| 200 IU recFSH | Number of Follicles Categorized by Size on the Day of hCG | >=17 mm | 5.6 Number of follicles | Standard Deviation 2.9 |
Secondary
Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)
The number of oocytes used for ICSI was assessed, and categorized based on their quality
Time frame: Up to 36 hours after administration of hCG (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. For participants who had ICSI; but also includes 3 participants whose oocytes were assessed, but ICSI was not performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) | Total | 13.8 Number of oocytes | Standard Deviation 7.7 |
| 150 µg Corifollitropin Alfa | Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) | Metaphase I | 1.1 Number of oocytes | Standard Deviation 1.5 |
| 150 µg Corifollitropin Alfa | Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) | Metaphase II | 10.8 Number of oocytes | Standard Deviation 6.5 |
| 150 µg Corifollitropin Alfa | Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) | Germinal vesicles | 1.4 Number of oocytes | Standard Deviation 1.9 |
| 200 IU recFSH | Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) | Germinal vesicles | 1.7 Number of oocytes | Standard Deviation 2.2 |
| 200 IU recFSH | Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) | Total | 12.2 Number of oocytes | Standard Deviation 6.4 |
| 200 IU recFSH | Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) | Metaphase II | 9.2 Number of oocytes | Standard Deviation 5.1 |
| 200 IU recFSH | Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI) | Metaphase I | 0.9 Number of oocytes | Standard Deviation 1.3 |
Secondary
Percentage of Fertilized Oocytes (Fertilization Rate)
The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI
Time frame: Up to 18 hours after start of fertilization (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.Restricted to participants with IVF and/or ICSI.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 150 µg Corifollitropin Alfa | Percentage of Fertilized Oocytes (Fertilization Rate) | 66.0 Percentage of fertilized oocytes | Standard Deviation 23.5 |
| 200 IU recFSH | Percentage of Fertilized Oocytes (Fertilization Rate) | 67.6 Percentage of fertilized oocytes | Standard Deviation 22.9 |
Secondary
Percentage of Gestational Sacs (Implantation Rate)
The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred.
Time frame: Up to 6 weeks after embryo transfer (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 150 µg Corifollitropin Alfa | Percentage of Gestational Sacs (Implantation Rate) | 36.2 Percentage of gestational sacs | Standard Deviation 41.6 |
| 200 IU recFSH | Percentage of Gestational Sacs (Implantation Rate) | 32.2 Percentage of gestational sacs | Standard Deviation 40.1 |
Secondary
Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt
Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.
Time frame: Two weeks after embryo transfer (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 150 µg Corifollitropin Alfa | Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt | 48.1 Percentage of participants |
| 200 IU recFSH | Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt | 46.9 Percentage of participants |
Secondary
Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer
Biochemical pregnancy was assessed for participants who had embryo transfer by measuring serum or urinary hCG. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.
Time frame: Two weeks after embryo transfer (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 150 µg Corifollitropin Alfa | Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer | 54.2 Percentage of participants |
| 200 IU recFSH | Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer | 50.0 Percentage of participants |
Secondary
Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy
The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth.
Time frame: Up to day of miscarriage (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a clinical pregnancy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 150 µg Corifollitropin Alfa | Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy | 8.4 Percentage of participants |
| 200 IU recFSH | Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy | 6.8 Percentage of participants |
Secondary
Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy
The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity.
Time frame: Up to day of miscarriage (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a vital pregnancy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 150 µg Corifollitropin Alfa | Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy | 2.3 Percentage of participants |
| 200 IU recFSH | Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy | 2.0 Percentage of participants |
Secondary
Serum Estradiol (E2) Levels During Stimulation
Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.
Time frame: Up to day of hCG treatment (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had E2 data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Serum Estradiol (E2) Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 126.13 pmol/L | Standard Deviation 39.17 |
| 150 µg Corifollitropin Alfa | Serum Estradiol (E2) Levels During Stimulation | Day 5 (Cori. Alfa N=725; recFSH N=722) | 1859.39 pmol/L | Standard Deviation 1224.78 |
| 150 µg Corifollitropin Alfa | Serum Estradiol (E2) Levels During Stimulation | Day 8 (Cori. Alfa N=708; recFSH N=678) | 3700.92 pmol/L | Standard Deviation 2837.41 |
| 150 µg Corifollitropin Alfa | Serum Estradiol (E2) Levels During Stimulation | Day of hCG (Cori. Alfa N=698; recFSH N=708) | 5486.67 pmol/L | Standard Deviation 3461.92 |
| 200 IU recFSH | Serum Estradiol (E2) Levels During Stimulation | Day of hCG (Cori. Alfa N=698; recFSH N=708) | 5154.88 pmol/L | Standard Deviation 2999.48 |
| 200 IU recFSH | Serum Estradiol (E2) Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 124.79 pmol/L | Standard Deviation 37.11 |
| 200 IU recFSH | Serum Estradiol (E2) Levels During Stimulation | Day 8 (Cori. Alfa N=708; recFSH N=678) | 3750.96 pmol/L | Standard Deviation 2600.03 |
| 200 IU recFSH | Serum Estradiol (E2) Levels During Stimulation | Day 5 (Cori. Alfa N=725; recFSH N=722) | 1392.97 pmol/L | Standard Deviation 895.66 |
Secondary
Serum FSH Levels During Stimulation
Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.
Time frame: Up to day of hCG treatment (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had FSH data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Serum FSH Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 6.70 IU/L | Standard Deviation 2.05 |
| 150 µg Corifollitropin Alfa | Serum FSH Levels During Stimulation | Day 5 (Cori. Alfa N=725; recFSH N=722) | 23.49 IU/L | Standard Deviation 6.22 |
| 150 µg Corifollitropin Alfa | Serum FSH Levels During Stimulation | Day 8 (Cori. Alfa N=708; recFSH N=678) | 11.76 IU/L | Standard Deviation 3.18 |
| 150 µg Corifollitropin Alfa | Serum FSH Levels During Stimulation | Day of hCG (Cori. Alfa N=698; recFSH N=708) | 12.54 IU/L | Standard Deviation 3.35 |
| 200 IU recFSH | Serum FSH Levels During Stimulation | Day of hCG (Cori. Alfa N=698; recFSH N=708) | 11.59 IU/L | Standard Deviation 2.8 |
| 200 IU recFSH | Serum FSH Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 6.60 IU/L | Standard Deviation 1.86 |
| 200 IU recFSH | Serum FSH Levels During Stimulation | Day 8 (Cori. Alfa N=708; recFSH N=678) | 11.59 IU/L | Standard Deviation 2.65 |
| 200 IU recFSH | Serum FSH Levels During Stimulation | Day 5 (Cori. Alfa N=725; recFSH N=722) | 11.61 IU/L | Standard Deviation 3.4 |
Secondary
Serum Inhibin-B Levels During Stimulation
Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment
Time frame: Up to day of hCG treatment (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had Inhibin-B data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Serum Inhibin-B Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=736; recFSH N=724) | 52.78 pg/mL | Standard Deviation 29.29 |
| 150 µg Corifollitropin Alfa | Serum Inhibin-B Levels During Stimulation | Day 5 (Cori. Alfa N=731; recFSH N=724) | 488.54 pg/mL | Standard Deviation 380.13 |
| 150 µg Corifollitropin Alfa | Serum Inhibin-B Levels During Stimulation | Day 8 (Cori. Alfa N=713; recFSH N=679) | 578.21 pg/mL | Standard Deviation 508.4 |
| 150 µg Corifollitropin Alfa | Serum Inhibin-B Levels During Stimulation | Day of hCG (Cori. Alfa N=704; recFSH N=710) | 608.35 pg/mL | Standard Deviation 489.52 |
| 200 IU recFSH | Serum Inhibin-B Levels During Stimulation | Day of hCG (Cori. Alfa N=704; recFSH N=710) | 612.19 pg/mL | Standard Deviation 435.26 |
| 200 IU recFSH | Serum Inhibin-B Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=736; recFSH N=724) | 52.95 pg/mL | Standard Deviation 27.02 |
| 200 IU recFSH | Serum Inhibin-B Levels During Stimulation | Day 8 (Cori. Alfa N=713; recFSH N=679) | 642.27 pg/mL | Standard Deviation 464.05 |
| 200 IU recFSH | Serum Inhibin-B Levels During Stimulation | Day 5 (Cori. Alfa N=731; recFSH N=724) | 493.86 pg/mL | Standard Deviation 329.71 |
Secondary
Serum Luteinizing Hormone (LH) Levels During Stimulation
Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.
Time frame: Up to day of hCG treatment (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had LH data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Serum Luteinizing Hormone (LH) Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 4.80 IU/L | Standard Deviation 2.02 |
| 150 µg Corifollitropin Alfa | Serum Luteinizing Hormone (LH) Levels During Stimulation | Day 5 (Cori. Alfa N=725; recFSH N=722) | 3.62 IU/L | Standard Deviation 4.6 |
| 150 µg Corifollitropin Alfa | Serum Luteinizing Hormone (LH) Levels During Stimulation | Day 8 (Cori. Alfa N=708; recFSH N=678) | 1.29 IU/L | Standard Deviation 1.8 |
| 150 µg Corifollitropin Alfa | Serum Luteinizing Hormone (LH) Levels During Stimulation | Day of hCG (Cori. Alfa N=698; recFSH N=708) | 1.38 IU/L | Standard Deviation 1.79 |
| 200 IU recFSH | Serum Luteinizing Hormone (LH) Levels During Stimulation | Day of hCG (Cori. Alfa N=698; recFSH N=708) | 1.86 IU/L | Standard Deviation 1.63 |
| 200 IU recFSH | Serum Luteinizing Hormone (LH) Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 4.67 IU/L | Standard Deviation 1.82 |
| 200 IU recFSH | Serum Luteinizing Hormone (LH) Levels During Stimulation | Day 8 (Cori. Alfa N=708; recFSH N=678) | 2.05 IU/L | Standard Deviation 1.8 |
| 200 IU recFSH | Serum Luteinizing Hormone (LH) Levels During Stimulation | Day 5 (Cori. Alfa N=725; recFSH N=722) | 2.23 IU/L | Standard Deviation 2.92 |
Secondary
Serum Progesterone (P) Levels During Stimulation
Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment
Time frame: Up to day of hCG treatment (up to 1 year)
Population: ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had P data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Serum Progesterone (P) Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 1.80 nmol/mL | Standard Deviation 1.28 |
| 150 µg Corifollitropin Alfa | Serum Progesterone (P) Levels During Stimulation | Day 5 (Cori. Alfa N=725; recFSH N=722) | 2.13 nmol/mL | Standard Deviation 1.97 |
| 150 µg Corifollitropin Alfa | Serum Progesterone (P) Levels During Stimulation | Day 8 (Cori. Alfa N=708; recFSH N=678) | 1.95 nmol/mL | Standard Deviation 1.06 |
| 150 µg Corifollitropin Alfa | Serum Progesterone (P) Levels During Stimulation | Day of hCG (Cori. Alfa N=698; recFSH N=708) | 3.20 nmol/mL | Standard Deviation 4.88 |
| 200 IU recFSH | Serum Progesterone (P) Levels During Stimulation | Day of hCG (Cori. Alfa N=698; recFSH N=708) | 3.16 nmol/mL | Standard Deviation 1.47 |
| 200 IU recFSH | Serum Progesterone (P) Levels During Stimulation | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 1.85 nmol/mL | Standard Deviation 1.42 |
| 200 IU recFSH | Serum Progesterone (P) Levels During Stimulation | Day 8 (Cori. Alfa N=708; recFSH N=678) | 2.64 nmol/mL | Standard Deviation 1.21 |
| 200 IU recFSH | Serum Progesterone (P) Levels During Stimulation | Day 5 (Cori. Alfa N=725; recFSH N=722) | 1.61 nmol/mL | Standard Deviation 0.87 |