A Phase II/III Extension Study Comparing the Long-term Safety of GenSci094 and Gonal-f® in Chinese ART Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Summary of Pregnancy Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing and able to sign informed consent
- •Subjects who participated in Phase II or Phase III clinical trial of GenSci094 and received at least one treatment with GenSci094 or Gonal-F ®
- •Subjects who indentified an ongoing pregnancy in Phase II or Phase III clinical trial of GenSci094
排除标准
- 未提供
结局指标
主要结局
Summary of Pregnancy Outcome
时间窗: To be assessed at late abortion or birth (up to 10 months)
Pregnancy outcomes were reported at the optional long-term follow up visit.
次要结局
- Infant development(up to infant age 12 months)
- neonatal birth outcomes(To be assessed at birth (up to 10 months))