NCT03081208已完成3 期
A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Oral Administration of Nolasiban to Improve Pregnancy Rates Following IVF or ICSI in Day 3 and Day 5 Fresh Embryo Transfer Cycles
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ObsEva SA
- 入组人数
- 810
- 试验地点
- 43
- 主要终点
- Intra-uterine 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 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.
详细描述
The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo 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)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 36 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 phase support with vaginal micronized progesterone.
- •Single, fresh D3 or D5 embryo transfer
排除标准
- •Frozen-thawed embryo transfer
- •More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
- •Serum P4 greater than 1.5 ng/mL on the day of hCG administration
研究组 & 干预措施
Nolasiban 900 mg
Experimental
干预措施: Nolasiban 900mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Intra-uterine pregnancy with fetal heart beat at 10 weeks
时间窗: 10 weeks post ET day
Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
次要结局
- Live birth(Up to 42 weeks of gestation)
- Miscarriage(From 6 weeks post ET to 24 weeks gestation)
- Intra-uterine pregnancy at 6 weeks(6 weeks post ET)
- Positive blood pregnancy test(14 days post OPU)
研究者
研究点 (43)
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