Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials 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
- 29
- 主要终点
- Pregnancy status at 20 weeks of gestation; Take-home baby rate
研究概览
简要总结
The objective of this trial was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.
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 any Phase IIa clinical trial of Org 36286 for OI or COH for IVF. 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 taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa;
- •Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation;
- •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) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg)
干预措施: Org 36286 (corifollitropin alfa) (Drug)
Experimental Group 2
Placebo
干预措施: Placebo (Drug)
Experimental Group 3
all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg)
干预措施: Org 36286 (corifollitropin alfa) (Drug)
Experimental Group 4
150 IU Puregon®
干预措施: recFSH (Drug)
结局指标
主要结局
Pregnancy status at 20 weeks of gestation; Take-home baby rate
时间窗: one pregnancy period
次要结局
- Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities(one pregnancy period)