81
Participants
Start Date
September 30, 2012
Primary Completion Date
November 30, 2014
Study Completion Date
December 31, 2014
MSJ-0011
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)
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
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.
Hanabusa Women's Central Fertility Clinic, Hyōgo
Bashamichi Ladies Clinic, Kanagawa
Sophia Ladies Clinic, Kanagawa
Ivf Namba Clinic, Osaka
Ivf Osaka Clinic, Osaka
Department of Obstetrics and Gynecology, Saitama Medical University Hospital, Saitama
Merck Serono Co., Ltd., Japan
INDUSTRY
Merck KGaA, Darmstadt, Germany
INDUSTRY