176
Participants
Start Date
March 24, 2023
Primary Completion Date
December 25, 2023
Study Completion Date
January 29, 2024
GenSci094
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg or 100μg (0.5 mL) GenSci094 was administered in the abdominal wall.
Placebo RecFSH / follitropin alfa
powder-injection, but without the active ingedient, SC injection . Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Biological: RecFSH / Follitropin alfa (Days 1 to 7)
Daily SC injections with 150IU or 225IU recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Placebo GenSci094
Pre-filled syringe containing an identical solution when compared to GenSci094. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
RecFSH / Follitropin alfa (Days 8 to hCG)
From Stimulation Day 8 onwards a daily SC dose 75IU~300 IU recFSH was administered up to and including the Day of hCG.
Ganirelix
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
hCG
When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
Progesterone
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 400 mg/day vaginally, and 40mg/d oral, which continued for at least 6 weeks, or up to menses.
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital, Guangzhou
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY