跳至主要内容
临床试验/NCT02636400
NCT02636400终止不适用

Is Postoperative IUI Better Than Expectant Management in Infertile Endometriosis Patients With Good Prognosis Based on EFI Score?

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
2
主要终点
cumulative clinical pregnancy rate

研究概览

简要总结

Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on their EFI score? (A single centre randomised controlled trial).

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 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • recent (<6months) complete laparoscopic endometriosis resection
  • endometriosis fertility index (EFI) at least 7/10
  • Regular menstrual cycles (min 24days - max 38days) with proven ovulation
  • At least one functional tube at surgery, normal uterus
  • Sperm sample of partner: normal or mild male factor

排除标准

  • frozen (donor or partner) sperm
  • clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization
  • FSH > 20 IU/L

结局指标

主要结局

cumulative clinical pregnancy rate

时间窗: participants will be followed for the duration of 7 menstrual cycles and in case of pregnancy, they will be followed until the pregnancy outcome is known, implying an average time frame of 1.5 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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