Trials / Active Not Recruiting
Active Not RecruitingNCT06321107
Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
A Phase II/III Extension Study Comparing the Long-term Safety of GenSci094 and Gonal-f® in Chinese ART Patients
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 158 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years – 39 Years
- Healthy volunteers
- —
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.
Conditions
Timeline
- Start date
- 2024-03-01
- Primary completion
- 2025-08-15
- Completion
- 2025-10-31
- First posted
- 2024-03-20
- Last updated
- 2025-04-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06321107. Inclusion in this directory is not an endorsement.