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临床试验/NCT00804960
NCT00804960撤回4 期

Controlled Ovarian Stimulation With Letrozole Supplementation

Center for Human Reproduction1 个研究点 分布在 1 个国家开始时间: 2008年9月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Cost of Treatment
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This research is being done to determine whether the success rate of in vitro fertilization treatment can be improved, while lowering the cost incurred from infertility medications using a pill called letrozole.

详细描述

Specific Aim:

  1. To determine whether addition of letrozole to gonadotropins would reduce the amount of gonadotropins used in an IVF-ET cycle, thereby reducing the cost.
  2. To determine whether letrozole improves IVF-ET success compared to standard ovarian stimulation protocols.

Null Hypothesis: Use of Letrozole for ovulation induction in IVF is not less expensive than the standard therapy by a clinically relevant amount.

Alternative Hypothesis: Use of Letrozole for ovulation induction in IVF is better than the standard therapy by a clinically relevant amount.

Protocol:

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
21 Years 至 38 Years（Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •Normal Ovarian Function
  • •Normal uterus

排除标准

  • •Age 40 and above
  • •Diminished ovarian reserve (based on markers and/or previous poor response)
  • •Previous oophorectomy

研究组 & 干预措施

Letrozole

Experimental
  1. Letrozole/ Recombinant FSH

干预措施: Letrozole (Drug)

Standard IVF

Active Comparator

luteal phase GnRHa suppression/gonadotropin

干预措施: Std IVF Protocol (Drug)

结局指标

主要结局

Cost of Treatment

时间窗: 4 weeks

次要结局

  • Pregnancy and implantation rates(4 weeks)
  • Incidence of Ovarian Hyper stimulation Syndrome(4 weeks)
  • Multiple Birth Rate(10 months)

研究者

申办方类型
Other

研究点 (1)

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