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

Infertility Clinical Trial

Official title:
A Phase II/III Extension Study Comparing the Long-term Safety of GenSci094 and Gonal-f® in Chinese ART Patients

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06321107
Study type Observational
Source Changchun GeneScience Pharmaceutical Co., Ltd.
Contact ShuQin Jiang, bachelor
Phone 18036617122
Email jiangshuqin@genscigroup.com
Status Recruiting
Phase
Start date February 29, 2024
Completion date October 31, 2025
View Details
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