Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01144416 | Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029) | PHASE3 | COMPLETED | 1,424 | — | — | Jun 1, 2010 | Apr 1, 2012 | Feb 3, 2022 | - | — |
Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle
| Arm | Type | Description |
|---|---|---|
| Single injection of 150 µg SCH 900962 (MK-8962) | EXPERIMENTAL | Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 |
| Daily 300 IU recFSH | ACTIVE_COMPARATOR | Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7 |
| Name | Type | Description |
|---|---|---|
| SCH 900962 / Corifollitropin alfa / Org 36286 | BIOLOGICAL | SCH 900962 will be provided as ready-for-use prefilled syringes containing 150 μg corifollitropin alfa per 0.5 mL. On day 2 or 3 of the menstrual cycle, a single dose of 150 μg corifollitropin alfa will be administered by subcutaneous injection in the abdominal wall in the morning. |
| RecFSH / follitropin beta | BIOLOGICAL | RecFSH will be provided as a ready-for-use solution in 900 IU cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of recFSH will be done in the morning by daily injections in the abdominal wall. A starting dose of 300 IU will be administered and fixed for at least 7 days. |
| Placebo for SCH 900962 | DRUG | Supplied as a pre-filled syringe containing an identical solution when compared to SCH 900962, however without the active ingredient corifollitropin alfa. On Day 2 or 3 of the menstrual cycle (=Stimulation Day 1), a single dose of placebo SCH 900962 is to be administered in the morning by subcutaneous injection in the abdominal wall. |
| Placebo for recFSH | DRUG | Supplied as identical ready-for-use solution, but without the active ingredient, in cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of placebo-recFSH will be done by daily injections in the abdominal wall in the morning for a period of 7 days. |
Inclusion Criteria: * Willing and able to provide written informed consent for trial P06029 as well as for the Frozen-Thawed Embryo Transfer (FTET) follow-up trial P06031, and for the pharmacogenetic analysis (if applicable). * Female and \>=35 to \<=42 years of age with indication for COS and IVF/...