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临床试验/NCT00417157
NCT00417157已完成不适用

Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation

Eugonia1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2007年1月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135
试验地点
1
主要终点
Live birth per started cycle

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal FSH, prior to proceeding to oocyte donation or abandoning fertility treatment.

详细描述

Poor responders are a diverse group of IVF patients who fail to respond to IVF drugs. In these patients pregnancy rates remain disappointingly low and usually oocyte donation is their only viable option. The need for lengthy ovarian stimulation regimes can be avoided by performing IVF during a natural menstrual cycle. However, the main problem with a natural cycle is that successful IVF outcome can be compromised by a premature LH surge. This problem can be solved by the administration of GnRH antagonists that suppress endogenous gonadotropin levels, comprising a modified natural cycle (MNC). Previous studies have shown that MNC offers no realistic chances of pregnancy prior to oocyte donation. In this study we will re-assess this view by showing that MNC offers some, albeit small, chances of positive IVF outcome in patients with known previous poor response prior to oocyte donation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Regular menstrual cycle (21-35 days)
  • Basal FSH>12 IU/ml
  • One or more failed IVF attempts (<3 oocyte retrieved)

排除标准

  • Normal responders

结局指标

主要结局

Live birth per started cycle

时间窗: live birth

次要结局

  • Biochemical pregnancy per started cycle(positive hCG test 14 days post oocyte retrieval)
  • Clinical pregnancy per started cycle(presence of fetal sac and heart beat at 7 weeks of gestation)
  • Cycle cancellation rates(cycles not reaching oocyte retrieval)
  • Ongoing pregnancy rates per started cycle(presence of fetal sac and heart beat at 12 weeks of gestation)

研究者

发起方
Eugonia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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