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临床试验/NCT02400801
NCT02400801已完成不适用

Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
166
试验地点
1
主要终点
clinical pregnancy rate per initiated ART cycle

研究概览

简要总结

Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? (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 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy
  • only first three ART cycles
  • normal uterine cavity
  • Eligible for ovarian stimulation with long agonist protocol

排除标准

  • FSH>20 IU/L
  • presence of large intramural fibroids (> 3 cm)
  • <4 oocytes obtained in any previous fresh ART cycle
  • ART with sperm derived from testicular biopsy
  • ART with Preimplantation Genetic Diagnosis/Screening

研究组 & 干预措施

oral oestroprogestogen pre-treatment

Active Comparator

preparation with oral oestroprogestogens prior to downregulation in an assisted reproductive technology treatment (ART) cycle

干预措施: ethinylestradiol + dienogest (Drug)

gonadotropin-releasing hormone (GnRH) pre-treatment

Experimental

preparation with gonadotropin-releasing hormone (GnRH) analogues prior to downregulation in an assisted reproductive technology treatment (ART) cycle

干预措施: triptorelin (Drug)

结局指标

主要结局

clinical pregnancy rate per initiated ART cycle

时间窗: participants will be followed for the duration of the ART cycle including the pregnancy test, an expected average of 10 weeks in the active comparator group and an expected average of 18 weeks in the experimental group

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 (1)

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