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 Details — Status: Recruiting

Administrative data

• NCT number: NCT06321107
• Other study ID #: GenSci094-304
• Status: Recruiting
• Start date: February 29, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2024
• Source: Changchun GeneScience Pharmaceutical Co., Ltd.
• Contact: ShuQin Jiang, bachelor
• Phone: 18036617122
• Email: jiangshuqin[@]genscigroup.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: October 31, 2025
• Est. primary completion date: August 15, 2025
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Changchun GeneScience Pharmaceutical Co., Ltd.	Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of Pregnancy Outcome	Pregnancy outcomes were reported at the optional long-term follow up visit.	To be assessed at late abortion or birth (up to 10 months)
Secondary	neonatal birth outcomes	To be assessed by the birth attendant/ Obgyne	To be assessed at birth (up to 10 months)
Secondary	Infant development	To assess infant's development, weight in grams/kilograms, height in centimeters and head circumference in centimeters are measured.	up to infant age 12 months