Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Chemical pregnancy rate
研究概览
简要总结
Research Question:
In women undergoing frozen embryo transfer, does routine endometrial injury before frozen embryo transfer increase clinical pregnancy rate?
Research Hypothesis:
(Null Hypothesis) In women undergoing frozen embryo transfer Routine endometrial injury before frozen embryo transfer does not increase clinical pregnancy rate.
(Alternative Hypothesis) In women undergoing frozen embryo transfer, endometrial injury before the transfer may increase pregnancy rate.
详细描述
Suitable women will be invited to participate in the study then a signed and informed consent will be obtained from them. When the patient's consent is obtained, they are to be included into the study.
Data Collection:
During first visit, all patients will undergo complete clinical examination and detailed medical history will be obtained. Each patient will have a Case Record Form (CRF) in which the following data will be recorded.
- Patient number (according to the randomization schedule).
- Age, BMI.
- Past medical and surgical history.
- Duration of infertility.
Procedure:
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
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All infertile women have high quality frozen embryos.
排除标准
- •History of endocrine disease such as: diabetes; Hyperthyroidism and Hyperprolactinemia.
- •History of hysteroscopic surgery due to intrauterine adhesions.
- •History of cardiovascular, renal or liver disease .
- •History of stroke or myocardial infarction.
- •Poor quality embryos.
- •Alcohol or Substance abuse.
研究组 & 干预措施
Group (A)
consists of 25 patients will receive frozen embryo with endometrial scratching on day 7 of transfer cycle.
干预措施: endometrial injury (Procedure)
Group (B)
consists of 25 patients will receive frozen embryo without endometrial scratching as control group.
结局指标
主要结局
Chemical pregnancy rate
时间窗: two weeks after frozen embryo transfer
serum Beta -Human Chorionic Gonadotropin positive
次要结局
- Clinical pregnancy rate(four weeks after frozen embryo transfer)
研究者
Yasser sherbiny
Principal Investigator
Ain Shams Maternity Hospital