Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- number of Early pregnancy
研究概览
简要总结
In spite of all progress realized in the field of assisted reproduction the pregnancy rate by In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle.
Different causes may account for these failures and that, during all stages of pregnancy.
Recent studies have investigated an essential step in fecundation : uterine receptivity. Some teams have shown that a lot of immunological factors would have very significant in this step, by them possible expression in this process. Other studies looked at genes modulation, essential to implantation, with endometrium manipulation, simple, such as endometrial biopsy (EB). The last findings published on this subject, but after 2 IVF failures, are most encouraging because the pregnancy rate for these teams after just endometrial local injury (EB after 2 IVF failures) is well above their usual pregnancy rate. Some teams have focused on immunoassay of endometrial biopsy, in order to profile uterine receptivity and suggest with results, suitable treatment for each patient (ongoing study).
EB is quick, easy, make in a simple consultation and with a low cost, contrary to immunological study, which depend of ultra-specialized laboratories and therefore with an important cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Only first IVF
- •Acceptance of protocol by patient after free and complete information and signature of consent.
- •Anti-Mullerian Hormone (AMH ) greater than 1
- •Member or eligible to social security system
- •Availabilities for a follow up 2 or 12 months.
排除标准
- •Known intolerance of proposed treatment
结局指标
主要结局
number of Early pregnancy
时间窗: Day 28
Early pregnancy is defined by beta human chorionic gonadotropin (HCG)\>100 mIU/ml defined by at least one rate of beta HCG\>100 on the 3 possible dosages after embryo transfer (if first dosage negative or \>100 : stop, if first dosage positive but \<100 : Second dosing, if \>100 or less than first result : stop, otherwise third dosing). Endometrial biopsy (diameter : 1mm ; length : 5mm) with use a pipelle, in the second part of the cycle between J17 and J22 during cycle before IVF
次要结局
- number of Live birth(delivery)
- number of patient with pain(Day 22 of previous cycle of IVF)
- number of patient with endometrial acute infection(Day 24 of previous cycle of IVF)
- number of patient with uterine perforation(Day 22 of previous cycle of IVF)
- Number of middle pregnancy(5 weeks of amenorrheas.)
- Number of late pregnancy(12 weeks of amenorrheas.)
- number of patient with endometrial chronic infection(Day 22 of previous cycle of IVF)