Endometrial Local Injury of Frozen Cycle to Improve the Outcome of Embryo Transfer of Repeated Implantation Failure.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- implantation rate
研究概览
简要总结
The purpose of this study is to determine whether edometrial local injury improves the outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of intervention,and the possible mechanism.
详细描述
It is important to evaluate the efficacy of endometrial local injury in assisted reproductive technology(ART),especially on the patients of recurrent implantation failure. Although most trials proved the effectiveness of the intervention of local injury, the subjects of these trials are rarely the patients of repeated implantation failure(RIF). Moreover, the mechanism of endometrial injury is not clear.Our trial may provide further basis for this purpose by comparing to the quality of endometrium in two-dimensional ultrasound.If the technique demonstrates efficacy, it would help the patients with RIF caused by poor conditions of endometrium to deal with the problem of infertility.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with RIF(≥2) of embyo transfer and uneven echo of endometrium on HCG day(12-14 days)
- •Without operation history of uterine cavity in the previous three months
- •Who agree to join in the study
排除标准
- •Women more than 40 years or less than 20 years
- •With infectious diseases or endocrine diseases
- •Who refuse to participate in the experiment
研究组 & 干预措施
Endometrial local injury
Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy.
干预措施: Endometrial local injury (Procedure)
The blank group
Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy.
结局指标
主要结局
implantation rate
时间窗: 3 months after intervention
When serum HCG is continuously more than 100mIU/ml and gestational sac is detected by ultrasound,it is considered as implantation.
次要结局
- live birth rate(follow-up for one year after pregnancy)
- clinical pregnancy rate(an expected average of 7 week after pregnancy)
- the change of three-dimensional ultrasound of uterine cavity before and after intervention(in implantation window period(12-14 days))
- infection rate(one week after intervention)
- the rate of birth defects(follow-up for one year after pregnancy)
- the expression changes of endometrial inflammatory factors(endometrial sampling after local injury ,in the first 3-5 days after menstrual period)
研究者
Yunhai Chuai
Department of Obstetrics and Gynecology, Navy General Hospital, Beijing
Navy General Hospital, Beijing