Approval Probability
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Adjusted LOA
ML Risk
MSJ-0011 · 1 trial · 4 indications
Ovulation was defined as mid-luteal serum progesterone level of \>= 5 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on transvaginal ultrasound (TVUS).
| Arm | Type | Description |
|---|---|---|
| MSJ-0011 | EXPERIMENTAL | - |
| urinary hCG | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MSJ-0011 | DRUG | Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 250 microgram (mcg) MSJ-0011 (choriogonadotropin alfa \[recombinant human Chorionic Gonadotropin, r-hCG\]) subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (\>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of \>=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL). |
| urinary hCG (u-hCG) | DRUG | Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of \>=18 mm; not more than 3 follicles each with a mean diameter of \>=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL. |
| Follitropin alpha | DRUG | Low-dose step-up protocol involves starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days (Day 8, 15, 28) will be done if no ovarian response will be observed for maximum of 28 days. |
Inclusion Criteria: * Premenopausal women aged between 20 to 39 years inclusive and wishing to conceive * Body Mass Index (BMI) of 17.0 to 29.0 kilogram per square meter (kg/m\^2) inclusive (value up to first decimal place) * No clinically significant abnormalities in serum thyroid stimulating horm...