NCT06091436

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

A Multicenter, Double-blind, Non-inferiority, Phase 3 RCT Comparing GenSci094 and Recombinant FSH During the First Seven Days of Ovarian Stimulation in Chinese ART Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of a single injection of GenSci094 to induce multi-follicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of GenSci094 is non-inferior to daily treatment with recFSH in initiating multi-follicular growth.

Conditions

• Infertility

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-24
• Primary completion: 2023-12-25
• Completion: 2024-01-29
• First posted: 2023-10-19
• Last updated: 2024-12-03

Locations

1 site across 1 country: China