Ovulation Induction
Conditions
Keywords
Infertility, Oligo-anovulation, GONAL-f®, AS900672-Enriched, hyperglycosylated recombinant human follicle stimulating hormone (r-hFSH)
Brief summary
This is a Phase 2, interventional, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI). This study will compare 4 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.
Detailed description
The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction (OI). This decision was not related to any safety or efficacy concerns over the use of AS900672-Enriched in OI.
Interventions
DRUGAS900672-Enriched 10 microgram (mcg)
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
DRUGAS900672-Enriched 20 mcg
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
DRUGAS900672-Enriched 30 mcg
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
DRUGAS900672-Enriched 40 mcg
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
DRUGFollitropin alfa 75 international unit (IU)
Follitropin alfa (Gonal-f®) 75 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 10, 20, 30 and 40 mcg will also receive daily dose of follitropin alfa 75 IU subcutaneously from Stimulation Day 7 (S7) up to S14. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm).
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
Inclusion criteria
* Oligo-anovulation defined by a menstrual period of 35 days to 6 months * Spontaneous menses or a positive response to progestin within the prior 6 months or response to clomiphene citrate evidenced by ovulation within the prior 6 months * Age between 18 and 36 years, inclusive, at time of informed consent signature * Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m\^2), inclusive * No clinically significant abnormalities in serum thyroid stimulating hormone (TSH), dehydroepiandrosterone (DHEA-S), prolactin, and FSH levels in the early follicular phase. Subjects low TSH level who receive replacement therapy could be enrolled at the discretion of the investigator if local laboratory results (thyroxine \[T4\]) demonstrated satisfactory thyroid function. Subjects receiving stable dose of dopamine agonists could be enrolled at the discretion of the investigator if local laboratory results demonstrated adequate control of prolactin levels * No clinically significant abnormalities in fasting glucose and fasting insulin levels * Normal uterine cavity and presence of at least one ovary with ipsilateral patent fallopian tube, as determined by means of hysterosalpingography, laparoscopy, hysteroscopy or combination of these procedures within the prior 3 years * Papanicolaou (PAP) smear test without clinically significant abnormalities within 6 months prior to the first screening procedure. If PAP smear is not done, it must be performed as part of screening procedures * Negative pregnancy test prior to randomization * Male partner with semen analysis demonstrating adequacy for insemination via intercourse and/or intrauterine insemination (IUI) within 6 months prior to the first screening procedure. If semen analysis is not done, it must be performed as part of screening procedures * Willing and able to comply with all protocol procedures, including pregnancy and neonatal follow-up * Voluntary provision of written informed consent, prior to any trial-related procedure that is not part of normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to her future medical care, including willingness to provide follow-up information on babies born as part of this trial
Exclusion criteria
* History of \>=2 consecutive gonadotrophin stimulation cycles that did not lead to ovulation * History of clomiphene citrate stimulation cycles of which none lead to ovulation * Prior excessive response to gonadotrophin stimulation, defined as the development of at least 4 mature follicles (greater than \[\>\]17 mm) or cancellation of the OI cycle due to excessive follicular response after treatment with FSH at a dose of less than 75 IU/day * Previous severe ovarian hyperstimulation syndrome (OHSS) * Administration of any gonadotrophin, clomiphene citrate, gonadotrophin releasing hormone (GnRH) analogue, tamoxifen or aromatase inhibitors within the prior 30 days * Laparoscopic ovarian drilling and/or ovarian cauterization within the prior 6 months * Any contraindication to pregnancy and/or to carrying pregnancy to term * A clinical pregnancy that ended in a miscarriage within the prior 3 months * History of \>=3 consecutive miscarriages, due to any cause * Abnormal gynecological bleeding of undetermined origin * Clinically significant abnormal findings of the uterine cavity evident on a transvaginal pelvic ultrasound performed during screening * Presence of endometriosis, Grade III - IV or requiring treatment * Ovarian cyst with a mean diameter of \>25 mm on the day of randomization * History or suspicion of ovarian, uterine or mammary cancer * Adrenal congenital hyperplasia, partial or complete enzymatic block * Use of metformin or other insulin sensitizing agents related to infertility within the prior 2 months * Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the trial * Any contra-indication to gonadotrophin therapy * Known or suspected infection with human immunodeficiency virus (HIV), Hepatitis B or C in the trial subject or her male partner * Any active substance abuse or history of drug, medication or alcohol abuse within 5 years * Smoker consuming more than 5 cigarettes per day * Serum testosterone (central laboratory) that is suggestive of ovarian tumor * Previously randomized in this trial or participation in another investigational drug clinical trial within the prior 3 months * Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of r-hFSH * Clinically significant concurrent disease (including diabetes mellitus and autoimmune diseases) that would compromise subject safety or interfere with the study assessments or clinically significant abnormal laboratory finding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Ovulation | Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days]) | Ovulation was defined as a mid-luteal phase progesterone (P4) level \>= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter \[ng/mL\]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Pregnancy | Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days]) | Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. |
| Duration of Ovarian Stimulation | Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days]) | Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day). |
| Duration of Supplemental Follitropin Alfa Treatment | Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days]) | — |
| Cumulative Dose of Supplemental Follitropin Alfa Administered | Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days]) | — |
| Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days]) | — |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AS900672-Enriched 10 Mcg Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | 14 |
| AS900672-Enriched 20 Mcg Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | 14 |
| AS900672-Enriched 30 Mcg Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | 15 |
| AS900672-Enriched 40 Mcg Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | 13 |
| Follitropin Alfa 75 IU Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =\< 3 follicles with a mean diameter of \>=14 mm, and one or two of these follicles with a diameter of \>=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days. | 15 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lack of ovarian response | 4 | 5 | 5 | 5 | 6 |
| Overall Study | Other | 1 | 1 | 0 | 0 | 1 |
| Overall Study | Ovarian hyperstimulation syndrome risk | 3 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol deviation | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Risk of multiple pregnancy | 0 | 2 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | AS900672-Enriched 10 Mcg | AS900672-Enriched 20 Mcg | AS900672-Enriched 30 Mcg | AS900672-Enriched 40 Mcg | Follitropin Alfa 75 IU | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 29.5 years | 31.5 years | 28.0 years | 30.0 years | 30.0 years | 30 years |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 15 Participants | 13 Participants | 15 Participants | 71 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 14 | 3 / 14 | 6 / 15 | 4 / 13 | 7 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 15 | 0 / 13 | 0 / 15 |
Outcome results
Primary
Percentage of Participants With Ovulation
Ovulation was defined as a mid-luteal phase progesterone (P4) level \>= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter \[ng/mL\]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.
Time frame: Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])
Population: Per Protocol (PP) population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AS900672-Enriched 10 Mcg | Percentage of Participants With Ovulation | 46.2 Percentage of participants |
| AS900672-Enriched 20 Mcg | Percentage of Participants With Ovulation | 46.2 Percentage of participants |
| AS900672-Enriched 30 Mcg | Percentage of Participants With Ovulation | 38.5 Percentage of participants |
| AS900672-Enriched 40 Mcg | Percentage of Participants With Ovulation | 33.3 Percentage of participants |
| Follitropin Alfa 75 IU | Percentage of Participants With Ovulation | 53.8 Percentage of participants |
Secondary
Cumulative Dose of Supplemental Follitropin Alfa Administered
Time frame: Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])
Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AS900672-Enriched 10 Mcg | Cumulative Dose of Supplemental Follitropin Alfa Administered | 476.3 IU | Standard Deviation 122.5 |
| AS900672-Enriched 20 Mcg | Cumulative Dose of Supplemental Follitropin Alfa Administered | 493.8 IU | Standard Deviation 108.3 |
| AS900672-Enriched 30 Mcg | Cumulative Dose of Supplemental Follitropin Alfa Administered | 556.7 IU | Standard Deviation 134.2 |
| AS900672-Enriched 40 Mcg | Cumulative Dose of Supplemental Follitropin Alfa Administered | 398.9 IU | Standard Deviation 167.9 |
| Follitropin Alfa 75 IU | Cumulative Dose of Supplemental Follitropin Alfa Administered | 397.5 IU | Standard Deviation 226.5 |
Secondary
Duration of Ovarian Stimulation
Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day).
Time frame: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])
Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AS900672-Enriched 10 Mcg | Duration of Ovarian Stimulation | 10.0 Days | Standard Deviation 5.3 |
| AS900672-Enriched 20 Mcg | Duration of Ovarian Stimulation | 11.8 Days | Standard Deviation 3.4 |
| AS900672-Enriched 30 Mcg | Duration of Ovarian Stimulation | 14.0 Days | Standard Deviation 1.4 |
| AS900672-Enriched 40 Mcg | Duration of Ovarian Stimulation | 10.8 Days | Standard Deviation 3.7 |
| Follitropin Alfa 75 IU | Duration of Ovarian Stimulation | 10.6 Days | Standard Deviation 3.2 |
Secondary
Duration of Supplemental Follitropin Alfa Treatment
Time frame: Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])
Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AS900672-Enriched 10 Mcg | Duration of Supplemental Follitropin Alfa Treatment | 6.6 Days | Standard Deviation 1.4 |
| AS900672-Enriched 20 Mcg | Duration of Supplemental Follitropin Alfa Treatment | 6.6 Days | Standard Deviation 1.4 |
| AS900672-Enriched 30 Mcg | Duration of Supplemental Follitropin Alfa Treatment | 7.7 Days | Standard Deviation 1.5 |
| AS900672-Enriched 40 Mcg | Duration of Supplemental Follitropin Alfa Treatment | 5.6 Days | Standard Deviation 2.2 |
| Follitropin Alfa 75 IU | Duration of Supplemental Follitropin Alfa Treatment | 5.5 Days | Standard Deviation 2.7 |
Secondary
Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm
Time frame: Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])
Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AS900672-Enriched 10 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S7 (n=12,12,13,12,12) | 22.8 Follicles | Standard Deviation 12.6 |
| AS900672-Enriched 10 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S7 (n=11,9,7,11,11) | 3.4 Follicles | Standard Deviation 6.2 |
| AS900672-Enriched 10 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S5 (n=12,12,12,12,13) | 23.6 Follicles | Standard Deviation 13.8 |
| AS900672-Enriched 10 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on r-hCG Day (n=5,6,7,6,7) | 15.6 Follicles | Standard Deviation 7.3 |
| AS900672-Enriched 10 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S5 (n=12,8,7,11,8) | 1.5 Follicles | Standard Deviation 2.2 |
| AS900672-Enriched 10 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on r-hCG Day (n=5,6,8,6,8) | 2.6 Follicles | Standard Deviation 0.9 |
| AS900672-Enriched 20 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on r-hCG Day (n=5,6,7,6,7) | 11.7 Follicles | Standard Deviation 9.2 |
| AS900672-Enriched 20 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on r-hCG Day (n=5,6,8,6,8) | 2.5 Follicles | Standard Deviation 1.9 |
| AS900672-Enriched 20 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S5 (n=12,8,7,11,8) | 0.0 Follicles | Standard Deviation 0 |
| AS900672-Enriched 20 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S7 (n=12,12,13,12,12) | 27.2 Follicles | Standard Deviation 30.9 |
| AS900672-Enriched 20 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S5 (n=12,12,12,12,13) | 28.7 Follicles | Standard Deviation 29.4 |
| AS900672-Enriched 20 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S7 (n=11,9,7,11,11) | 0.2 Follicles | Standard Deviation 0.7 |
| AS900672-Enriched 30 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S5 (n=12,12,12,12,13) | 23.2 Follicles | Standard Deviation 6.7 |
| AS900672-Enriched 30 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on r-hCG Day (n=5,6,7,6,7) | 18.4 Follicles | Standard Deviation 12.1 |
| AS900672-Enriched 30 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on r-hCG Day (n=5,6,8,6,8) | 2.5 Follicles | Standard Deviation 1.3 |
| AS900672-Enriched 30 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S5 (n=12,8,7,11,8) | 1.6 Follicles | Standard Deviation 1.9 |
| AS900672-Enriched 30 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S7 (n=11,9,7,11,11) | 2.6 Follicles | Standard Deviation 3.5 |
| AS900672-Enriched 30 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S7 (n=12,12,13,12,12) | 21.0 Follicles | Standard Deviation 8.9 |
| AS900672-Enriched 40 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S7 (n=12,12,13,12,12) | 21.3 Follicles | Standard Deviation 17.3 |
| AS900672-Enriched 40 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on r-hCG Day (n=5,6,7,6,7) | 18.7 Follicles | Standard Deviation 15 |
| AS900672-Enriched 40 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on r-hCG Day (n=5,6,8,6,8) | 1.8 Follicles | Standard Deviation 0.8 |
| AS900672-Enriched 40 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S5 (n=12,8,7,11,8) | 2.8 Follicles | Standard Deviation 3.1 |
| AS900672-Enriched 40 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S5 (n=12,12,12,12,13) | 20.9 Follicles | Standard Deviation 16.7 |
| AS900672-Enriched 40 Mcg | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S7 (n=11,9,7,11,11) | 2.8 Follicles | Standard Deviation 2.4 |
| Follitropin Alfa 75 IU | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on r-hCG Day (n=5,6,8,6,8) | 2.9 Follicles | Standard Deviation 1.8 |
| Follitropin Alfa 75 IU | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S5 (n=12,12,12,12,13) | 21.3 Follicles | Standard Deviation 13.7 |
| Follitropin Alfa 75 IU | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on S7 (n=12,12,13,12,12) | 22.0 Follicles | Standard Deviation 16.7 |
| Follitropin Alfa 75 IU | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | < 11 mm on r-hCG Day (n=5,6,7,6,7) | 14.9 Follicles | Standard Deviation 12.4 |
| Follitropin Alfa 75 IU | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S5 (n=12,8,7,11,8) | 0.8 Follicles | Standard Deviation 0.9 |
| Follitropin Alfa 75 IU | Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm | >= 11 mm on S7 (n=11,9,7,11,11) | 1.8 Follicles | Standard Deviation 2.3 |
Secondary
Percentage of Participants With Clinical Pregnancy
Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.
Time frame: Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
Population: PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AS900672-Enriched 10 Mcg | Percentage of Participants With Clinical Pregnancy | 23.1 Percentage of participants |
| AS900672-Enriched 20 Mcg | Percentage of Participants With Clinical Pregnancy | 0.0 Percentage of participants |
| AS900672-Enriched 30 Mcg | Percentage of Participants With Clinical Pregnancy | 7.7 Percentage of participants |
| AS900672-Enriched 40 Mcg | Percentage of Participants With Clinical Pregnancy | 16.7 Percentage of participants |
| Follitropin Alfa 75 IU | Percentage of Participants With Clinical Pregnancy | 0.0 Percentage of participants |