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临床试验/EUCTR2013-005420-42-BE
EUCTR2013-005420-42-BE进行中(未招募)1 期

Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on EFI score? - POSTOP IUI

niversity Hospital Leuven0 个研究点目标入组 94 人开始时间: 2014年1月2日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
94

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • 1. age between 18 and 37 (incl)
  • 2. histologically proven endometriosis with complete resection of all endometriosis lesions during laparoscopy at LUFc
  • 3. EFI score of 7 or more
  • 4. Surgery performed not more than 6 months prior to randomization
  • 5. Regular menstrual cycles (min 24days – max 38days) with proven ovulation
  • 6. At least one functional tube at surgery
  • 7. Sperm sample of partner:
  • normal or mild male factor
  • fresh sample (not frozen/thawed)
  • TMC (total motile sperm count after capacitation) minimally 5 million
  • 8. normal uterine cavity (including arcuate uterus) at hysteroscopy and/or hysterosalpingography and/or gel instillation sonography
  • 9. Postoperative hormone testing: basal FSH below 20 IU/l; AMH measurement needs to be available
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 94
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - frozen (donor or partner) sperm
  • - clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization

研究者

发起方
niversity Hospital Leuven

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