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临床试验/NCT01798836
NCT01798836终止2 期

Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

National and Kapodistrian University of Athens2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
17
试验地点
2
主要终点
Live birth rate

研究概览

简要总结

To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH agonist /GnRH antagonist protocol

详细描述

The combined ultrashort flare GnRH agonist /GnRH antagonist protocol during COH cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated IVF failures and in poor responders. This is a protocol combining the effect of the microdose flare on endogenous FSH release with the benefit of an immediate LH suppression of the GnRH antagonist.

A major disadvantage of the use of a GnRH antagonist protocol is the limitation for programming cycles, as the drugs administration is started on day 2 of the menstrual cycle and is strictly followed until the hCG criteria are met.

The purpose of the study is to perform oestradiol pre-treatment with the combined ultrashort flare GnRH agonist /GnRH antagonist protocol aiming to

  1. better programme an antagonist cycle and
  2. improve the IVF outcome parameters, from the production of more follicles / oocytes up to the rise in live birth rates.

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
25 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with poor or no response in previous COH for IVF cycles
  • Patients with AMH < 1 and/or FSH >12
  • Poor quality of embryos in previous cycles
  • Age of patients up to 44 years

排除标准

  • Patients with normal ovarian reserve
  • Patients with sonographically detected hydrosalpinges
  • Presence of intramural fibroid distorting the endometrial cavity or submucous myoma or Asherman's syndrome
  • Women with thrombofilia disorders

结局指标

主要结局

Live birth rate

时间窗: 2 years

Clinical pregnancy rate

时间窗: 2 years

次要结局

  • Ectopic pregnancy(2 years)
  • Miscarriage rate(2 years)
  • Number of oocytes retrieved(2 years)
  • Top embryo quality at day 2(2 years)
  • Biochemical pregnancy(2 years)

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 in Obstetrics and Gynecology/Assisted Reproduction

National and Kapodistrian University of Athens

研究点 (2)

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