A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ObsEva SA
- 入组人数
- 820
- 试验地点
- 50
- 主要终点
- Ongoing pregnancy with fetal heart beat at 10 weeks
研究概览
简要总结
The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.
详细描述
The study is a prospective, randomised, parallel group, double-blind, placebo-controlled, Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Indicated for IVF/ICSI in the context of assisted reproductive technology (ART)
- •Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal support with vaginal micronized progesterone.
- •Single fresh D5 embryo transfer
排除标准
- •Frozen-thawed embryo transfer
- •Donor egg in the current transfer
- •More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
- •Serum P4 greater than 1.5 ng/mL prior to hCG administration
研究组 & 干预措施
Nolasiban 900 mg
Nolasiban dispersible tablets for single oral administration
干预措施: Nolasiban (Drug)
Placebo
Placebo dispersible tablets for single oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Ongoing pregnancy with fetal heart beat at 10 weeks
时间窗: 10 weeks post ET day
Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
次要结局
- Clinical pregnancy at 6 weeks post ET day(6 weeks post ET)
- Live birth(24 to 40 weeks of gestation)
- Plasma concentrations of nolasiban(3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration)
- Pregnancy rate at 14 days post Oocyte Pick-up (OPU)(14 days post OPU)
- Pregnancy loss(6 weeks post ET to 24 weeks gestation)