Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Clinical Trial 38826 for the Development of Org 36286 (Corifollitropin Alfa).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Pregnancy status at 20 weeks of gestation
研究概览
简要总结
The objective of this trial was to evaluate whether Org 36286 treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) is safe for pregnant subjects and their offspring.
详细描述
This was an open, prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during Trial 38826. For this trial, no study specific assessments were required, but information obtained in standard practice was used.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who participated in Trial 38826 and became pregnant (as confirmed by USS at or beyond 10 weeks after ET) after having received at least one dose of either Org 36286 or Puregon®; and
- •Able and willing to give written informed consent.
排除标准
- 未提供
研究组 & 干预措施
Experimental Group 1
all doses of Org 36286 (corifollitropin alfa) (60 μg, 120 μg and 180 μg)
干预措施: Org 36286 (Drug)
Experimental Group 2
150 IU recFSH
干预措施: recFSH (Drug)
结局指标
主要结局
Pregnancy status at 20 weeks of gestation
时间窗: one pregnancy period
Take-home baby rate
时间窗: one pregnancy period
次要结局
- Infant follow-up(one pregnancy period)
- Pregnancy follow-up(one pregnancy period)
- Congenital malformations and chromosomal abnormalities(one pregnancy period)
- Delivery follow-up(one pregnancy period)
- Neonatal outcome(one pregnancy period)