Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference

Active, not recruiting

• Conditions: Infertility

• Registration Number: NCT06321107
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the safety of a single injection of GenSci094 during Controlled Ovarian Stimulation up to 1 year old of the infants from previous studies.

Detailed Description

Two previous RCTs (a phase II and phase III studies of GenSci094, one is NCT06091436) investigated if a single injection of GenSci094 was non-inferior to daily treatment with recFSH in initiating multi-follicular growth. The two studies followed 12 weeks after embryo transfer. This study is a follow-up to the above mentioned RCTs. The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a single injection of GenSci094 during Controlled Ovarian Stimulation might have on newborns until they are 1 year old.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-17
• Study First Posted: 2024-03-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-08-15
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 158

Inclusion Criteria

1. Willing and able to sign informed consent
2. Subjects who participated in Phase II or Phase III clinical trial of GenSci094 and received at least one treatment with GenSci094 or Gonal-F ®
3. Subjects who indentified an ongoing pregnancy in Phase II or Phase III clinical trial of GenSci094

Exclusion Criteria

NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Summary of Pregnancy Outcome	To be assessed at late abortion or birth (up to 10 months)	Pregnancy outcomes were reported at the optional long-term follow up visit.

Secondary Outcome Measures

Name	Time	Method
Infant development	up to infant age 12 months	To assess infant's development, weight in grams/kilograms, height in centimeters and head circumference in centimeters are measured.
neonatal birth outcomes	To be assessed at birth (up to 10 months)	To be assessed by the birth attendant/ Obgyne

Trial Locations

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital; 🇨🇳 Guangzhou, Guangdong, China