跳至主要内容
临床试验/NCT04497558
NCT04497558已完成不适用

The Clinical Efficiency of Transcriptome-based Endometrial Receptivity Assessment (Tb-ERA) in Chinese Patients With Recurrent Implantation Failure (RIF)

ShangHai Ji Ai Genetics & IVF Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.

详细描述

In the field of assisted reproduction techonology, there are still 10% of patients with repeated implantation failure. In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed. Statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (endometrial implantation window evaluation results, embryo implantation rate, biochemical pregnancy rate, early abortion rate, ectopic pregnancy rate) are done. Through the comparative analysis of clinical outcomes to verify the clinical efficacy of endometrial receptivity analysis in patients with repeated implant failure, this method will provide a new treatment for repeated implant failure population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • People with unexplained repeated implantation failure (3 or more times of transplantation, at least 4 or more high-quality embryos failed to conceive).
  • Age: 20-40 years old.
  • The thickness of endometrium is more than or equal to 7 mm.

排除标准

  • Known causes of embryo implantation failure, such as infection, reproductive tract malformation, uterine cavity factors, immune factors, hydrosalpinx, etc.
  • Decreased ovarian function (meet the following at least two criteria: ① 10u / L < basal follicle stimulating hormone (FSH) < 25U / L, and / or estradiol (E2) > 292.8pmol/l, and / or FSH / LH > 3; ② the number of antral follicles < 5-7 on the second to third day of menstruation; and (or) antimullerian hormone (AMH) < 0.5-1.1ng/ml.
  • People with genetic history.
  • Those who have done abortion and the histogenetic analysis are positive.

结局指标

主要结局

Clinical pregnancy rate

时间窗: 6 months

Clinical pregnancy rate in patients

次要结局

  • Early abortion rate(6 months)
  • Embryo implantation rate(6 months)
  • Biochemical pregnancy rate(6 months)
  • Ectopic pregnancy rate(6 months)
  • Endometrial implantation window evaluation results(6 months)

研究者

发起方
ShangHai Ji Ai Genetics & IVF Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenbi Zhang

Clinical Professor

ShangHai Ji Ai Genetics & IVF Institute

研究点 (1)

Loading locations...

相似试验