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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8962-029 | Other Identifier | Merck |
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This study, conducted in India, will be recruiting women participants who are between the ages of 18 and 42, and who have an indication for controlled ovarian stimulation (COS), but have not yet undergone in-vitro fertilization and/or intracytoplasmic sperm injection (IVF/ICSI). The study is designed to compare the difference in oocyte (immature egg cell) production after administration of the investigative drug, MK-8962 (corifollitropin alfa) + recombinant follicle stimulating hormone (recFSH), in contrast to use of only the reference drug, recFSH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Dose MK-8962 + recFSH | Experimental |
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| Reference Group recFSH only | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8962 | Drug | MK-8962 is supplied in a ready-to-use prefilled syringe containing 100 microgram (μg) or 150 μg corifollitropin alfa per 0.5 mL. Participants are randomized to receive a single subcutaneous (SC) injection of MK-8962 in the abdominal wall on Cycle Day 2 or Cycle Day 3. Dose of administered MK-8962 is weight-based. Participants who weigh 60 kilograms (kg) or less will be given 100 μg MK-8962 and those who weigh more than 60 kg will be given 150 μg MK-8962. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cumulus-Oocyte-Complexes Retrieved During Oocyte Pick-up | The criterion of hCG administration is defined as three or more follicles ≥17 mm, confirmed by ultrasound. Oocyte pick up occurs 34-36 hours after the Day of hCG Administration, based on confirmed ultrasound findings. | 34 to 36 hours after Day of Administration of Human Chorionic Gonadotropin (hCG) |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmation of Vital Pregnancy | Per study protocol, vital pregnancy is defined as the presence of at least one fetus with heart activity at approximately 5 weeks (ie, ~ 35 days) after Day of Embryo Transfer in the COS treatment cycle. | Post treatment; at 35 days from Day of Embryo Transfer |
| Percentage of Participants with Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS) |
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Inclusion Criteria:
Please Note: In this trial an Indian female participant is defined as a woman 1) with native Indian parents, and 2) who is also in possession of an Indian identification card.
Exclusion Criteria:
- Has a recent (ie, within 3 years prior to enrollment in study) history of/or
any active endocrine abnormality, treated or untreated.
the last established ongoing pregnancy, if applicable.
Hepatitis B
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| recFSH | Drug | Recombinant Follicle Stimulating Hormone (recFSH) will be supplied as a ready-to-use solution in a 600 IU cartridge for SC injection via the recFSH Pen. Starting on Day 2 or 3 of the menstrual cycle (Stimulation Day 1), recFSH will be administered daily, each morning, via injections in the abdominal wall. A starting dose of between 150 - 300 IU will be administered and is fixed for the first week of stimulation. After 6 days, and based on each participant's individual response, the Investigator may decide to reduce the fixed dose for the remainder of the study. The maximum duration of stimulation is 19 days; recFSH will not be administered on the Day of hCG Administration. |
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| Ganirelix | Drug | 0.25 mg/day SC injection in the upper leg, administered on Stimulation Day 5 up to and including Day of hCG Administration |
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| human Chorionic Gonadotropin (hCG) | Drug | Single dose of 10,000 or 5,000 IU hCG, administered via SC injection on Day of hCG Administration. |
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| Progesterone | Drug | Crinone 8% (90 mg) gel administered intravaginally via a single-use, one piece polyethylene vaginal applicator once-daily on Day of Oocyte Pick-up or 1 day later and continued for at least 6 weeks or either up to menses or up to a negative pregnancy test performed at least 18 days after Day of Oocyte Pick-up. |
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Per study protocol, OHSS is defined as more than 30 follicles ≥11 mm in size demonstrated by ultrasound. |
| From Baseline up to 10 weeks after Day of Embryo Transfer |
| Number of Participants with an Ongoing Pregnancy | Per study protocol, ongoing pregnancy is defined as confirmed pregnancy at 10 or more weeks ( ~ 70 days) after Day of Embryo Transfer, documented by a positive pregnancy test and ultrasound scan demonstrating at least one gestational sac with heart activity. | Post treatment; at approximately 10 weeks from Day of Embryo Transfer |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| C571802 | follitropin beta |
| C061018 | ganirelix |
| D006063 | Chorionic Gonadotropin |
| D011374 | Progesterone |
| C400424 | Crinone |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
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