To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference

PHASE3CompletedINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

March 24, 2023

Primary Completion Date

December 25, 2023

Study Completion Date

January 29, 2024

Conditions
Infertility
Interventions
DRUG

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.

DRUG

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

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.

DRUG

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.

BIOLOGICAL

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.

DRUG

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

BIOLOGICAL

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

DRUG

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.

Trial Locations (1)

510610

The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital, Guangzhou

All Listed Sponsors
collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

lead

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY