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临床试验/NCT01798862
NCT01798862已完成2 期

The Effect of Endometrial Injury on IVF Outcome Parameters in Patients With Repeated Implantation Failures

National and Kapodistrian University of Athens3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
3
主要终点
positive bHCG rate

研究概览

简要总结

The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.

详细描述

Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Personal history of 2 or more failed IVF/ICSI cycles (RIF)
  • Age</= 42 years
  • Good response with good quality embryos in previous attempts (>2)

排除标准

  • Personal history of endometrial tuberculosis/ antituberculous treatment
  • Sonographically detected hydrosalpinges
  • Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
  • Thrombophilia

结局指标

主要结局

positive bHCG rate

时间窗: through study completion, an average of 2 years

次要结局

  • live birth rate(2 years)
  • clinical pregnancy rate(2 years)
  • Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA)(2 years)
  • Ectopic pregnancy rate(2 years)
  • Miscarriage rate(2 years)
  • Ongoing pregnancy rate(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siristatidis Charalampos, MD, PhD

Assistant Professor in Obstetrics and Gynecology / Assisted Reproduction

National and Kapodistrian University of Athens

研究点 (3)

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