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

GeneScience Pharmaceuticals (GenSci)

Status: Active, not recruiting

Conditions: Infertility

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06321107

GenSci094-304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 estimated patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No 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

Trial design

158 participants in 2 patient groups

Test group

Description:

Gensci094

Control group

Description:

rFSH