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临床试验/NCT01319708
NCT01319708已完成1 期

Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation

National and Kapodistrian University of Athens2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年3月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
50
试验地点
2
主要终点
number of oocytes (COCs)

研究概览

简要总结

The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.

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
Single (Participant)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • poor responders (age>40, previous POR, abnormal OR test)
  • indication for IVF
  • regular cycling patients
  • BMI 19-35

排除标准

  • contraindication for clomiphene citrate use or to GnRH agonists antagonists
  • BMI > 35

研究组 & 干预措施

mild ovarian stimulation

Experimental

100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering

干预措施: mild ovarian stimulation (Procedure)

conventional ovarian stimulation

Active Comparator

300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses using a GnRH agonist long protocol

干预措施: conventional ovarian stimulation (Procedure)

结局指标

主要结局

number of oocytes (COCs)

时间窗: at oocyte recovery

次要结局

  • Number/rate of participants whom the IVF cycle was cancelled(After the 1st week of ovarian stimulation, no oocytes at OR)
  • clinical pregnancy rate(6 weeks)
  • cancellation rate(from start of stimulation until ET)
  • live birth(more than 20 weeks)
  • miscarriage(pregnancy loss before 20 weeks of gestation, after a positive pregnancy test)
  • stimulation characteristics(from start of stimulation until embryo transfer)

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, Director of the ARU

National and Kapodistrian University of Athens

研究点 (2)

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