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临床试验/NCT02128360
NCT02128360Unknown不适用

Analysis of IVF Outcome After Minimal Stimulation vs. High Dose Stimulation for Patients With Low Ovarian Reserve

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年3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
入组人数
200
试验地点
1
主要终点
Clinical pregnancy rates

研究概览

简要总结

The purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared.

详细描述

A prospective randomized trial will be carried out. The Minimal stimulation (MS) protocol is based on low dose letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the letrozole at 150 units per day. GnRH antagonist wil be introduced to avoid premature LH surge when one or more of the growing follicles reached approximately 14 mm in size. The high dose stimulation protocol is based on high dose of gonadotropins (≥300 IU/day) throughout the cycle with the usage of gonadotropin-releasing hormone (GnRH) antagonist to avoid premature luteinizing hormone (LH) surge as described above.

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 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of poor responder to ovarian stimulation

排除标准

  • Patients undergoing pregestational diagnosis (PGD)
  • Patients using donor eggs

研究组 & 干预措施

Minimal stimulation protocol

Active Comparator

Low dose Letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the Letrozole at 150 units per day. GnRH antagonist to avoid premature LH surge will be introduced when one or more of the growing follicles reached approximately 14 mm in size

干预措施: Letrozole, Gonadotropins (Drug)

High dose protocol

Active Comparator

High dose of gonadotropins (≥300 IU/day) starting from cycle day 3. GnRH antagonist will be introduced to avoid premature LH surge when one or more of the growing follicles will reach approximately 14 mm in size

干预措施: Gonadotropins (Drug)

结局指标

主要结局

Clinical pregnancy rates

时间窗: 1 Year

次要结局

  • Number of High quality embryos(1 year)
  • Number of eggs retrieved(1 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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