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临床试验/NCT03748238
NCT03748238Unknown不适用

Systematic And Standardized Hysteroscopic Endometrial Injury For Treatment Of Recurrent Implantation Failure

Gurgan Clinic2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
230
试验地点
2
主要终点
Positive Pregnancy

研究概览

简要总结

The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.

详细描述

This is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. Approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. Injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. This study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women under the age of 40 who met the RIF definition
  • Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL

排除标准

  • Patients with congenital uterine anomalies
  • Patients with Asherman's syndrome
  • Patients with uterine cavity distorted by myoma or endometrial polyps
  • Patients with confirmed endometriosis or endometrioma
  • Patients with BMI of <18.5 and >29.9

研究组 & 干预措施

Injury group

Experimental

Endometrial injury with hysteroscopy

干预措施: Endometrial Injury with Hysteroscopy (Procedure)

Control group

No Intervention

No hysteroscopy

结局指标

主要结局

Positive Pregnancy

时间窗: 1month

Blood concentration of beta-hcg

次要结局

未报告次要终点

研究者

发起方
Gurgan Clinic
申办方类型
Network
责任方
Principal Investigator
主要研究者

Muberra Namlı Kalem

Assoc Professor, MD

Gurgan Clinic

研究点 (2)

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