NCT01723982已完成2 期
A Randomised, Placebo-controlled, Double-blind, Parallel Groups, Multinational, Multicentre Trial Assessing the Effect of Barusiban Administered Subcutaneously on the Day of Transfer on Implantation and Pregnancy Rates in IVF/ICSI Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 14
- 主要终点
- Ongoing implantation rate
研究概览
简要总结
This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment
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
- Double (Participant, Investigator)
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
- •Women aged 18-37 years
- •Women who have undergone 2-4 previous fresh in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) cycles that all resulted in a negative βhCG test, despite transfer of at least one embryo/blastocyst of good quality
- •Women who have in the current controlled ovarian stimulation cycle for IVF/ICSI followed the long Gonadotrophin Releasing Hormone (GnRH) agonist or GnRH antagonist protocol, received hCG for triggering of final follicular maturation and have undergone oocyte retrieval for IVF/ICSI with the purpose of fresh transfer
- •Retrieval of at least 6 oocytes in the current controlled ovarian stimulation cycle
- •Subjects should have at least one embryo of good quality available for transfer on day 3, or at least one good quality blastocyst available for transfer on day 5
排除标准
- •A total of 6 or more controlled ovarian stimulation cycles for IVF/ICSI
- •Abnormal karyotype
- •Uterine pathology or hydrosalpinx
- •Diagnosed with acquired or congenital thrombophilia disease
研究组 & 干预措施
A. FE 200440
Experimental
Barusiban (FE 200440) Solution for Injection for Subcutaneous use
干预措施: Barusiban (FE 200440) (Drug)
B. Placebo
Placebo Comparator
Placebo Solution for Injection for Subcutaneous use
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Ongoing implantation rate
时间窗: 10-11 weeks after embryo transfer
次要结局
- Frequency and intensity of injection site reactions(Immediately and 30 min after each administration of IMP)
- Ongoing pregnancy rate(10-11 weeks after transfer)
- Implantation rate(5-6 weeks after transfer)
- Clinical pregnancy rate(5-6 weeks after transfer)
- Frequency and intensity of adverse events(Within 60 days of oocyte retrieval +1 day until 10 -11 weeks after embryo transfer)
- Positive Beta Human Chorionic Gonadotrophin (βhCG) rate(13-15 days after transfer)
- Serum barusiban concentration at the expected tmax(30 min after 2nd IMP administration)
研究者
研究点 (14)
Loading locations...
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