Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Fertilization rates
研究概览
简要总结
cFEE peptide improves the IVF fertilization rate in mouse and fertilization index in human. It improves sperm movement's parameters.
It has been studied over 3 generations of mice and appears without any side effects. The Agence de la BioMédecine has given the authorization for testing the peptide in human IVF.
It is expected to improve the fertilization rate, and thus provide more embryos per IVF attempt.
160 couples will be included over 15 months. Patient sperm parameters should be suitable for IVF. Female should be between 18 and 43 year old. Each cohort of eggs will be randomly distributed to one of the 2 groups The first group will be inseminated with 100000/ml motile spermatozoa. The second will be similarly inseminated but in a middle which will be supplemented with cFEE 100µM.
Criteria: number of embryos in each group
详细描述
Name and address of the coordinating investigator : Prof. Jean Philippe Wolf, Histology - Embryology Department , Biology of Reproduction - . Cochin Hospital , 123 Bd Port Royal, 75014 Paris Promotor: AP- HP represented by DRCD - Hôpital Saint- Louis Inclusion Sites : CHU Cochin, Paris
Main objective:
- To improve fertilization rate in IVF by supplementation of culture media with a molecule increasing the sperm fertilizing ability.
Secondary objectives
- Compare the rates of cleavage between the two groups of zygotes
- Compare the percentage of good quality embryos
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
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for in vitro fertilization except indication of ICSI. That is to say : the patients whose sperm has the following characteristics :
- •Sperm count over 107 spz /ml and Mobility * ( a + b ) is greater than 15 %
- •Typical forms above 10%
- •Women aged 18 to 43 years.
- •Patients gave their informed written consent
- •People affiliated to a social security system
排除标准
- •Patients whose sperm indicates the use or ICSI
- •Patients who have not given their consent or without the consent of one of the two spouses
- •Ovarian failure , menopause
结局指标
主要结局
Fertilization rates
时间窗: 24 hours
次要结局
- Embryo quality(day 5)
- Pregnancy outcome(9 months)
- Baby health(Year one)