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

NCT06321107 · tracked via the Priya Life Science China tracker

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Phase

Observational

Started

2024-03-01

Last updated

2025-04-08

Condition(s) studied

Infertility

Study 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.

Eligibility

Sex

FEMALE

Min age

20 Years

Max age

39 Years

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06321107 on ClinicalTrials.gov ↗ ← All trials in China