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临床试验/NCT02173977
NCT02173977Unknown2 期

Ultrashort Flare GnRH Agonist Combined With Flexible Multidose GnRH Antagonist Versus Flexible Multidose GnRH Antagonist for Good-prognosis IVF Patients

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
2 期
入组人数
200
试验地点
2
主要终点
Ongoing pregnancy rates

研究概览

简要总结

The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist protocol.

The investigators hypothesized that combining the stimulatory effect of GnRH agonists and immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH strategy for IVF patients, resulting in improved ART outcome.

详细描述

The ultrashort flare GnRH agonist combined with flexible multidose 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 protocol combines the effect of the microdose flare on endogenous follicle stimulating hormone (FSH) release with the benefit of an immediate luteinizing hormone suppression of the GnRH antagonist.

The basic hypothesis of this approach can also benefit IVF patients with good prognosis without compromising the ability to use gonadotrophin-releasing hormone (GnRH) agonist to effectively trigger ovulation, while completely eliminating any threat of clinically significant ovarian hyperstimulation syndrome (OHSS).

The purpose of the study is to compare cycles consisting of ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist with those using the flexible multidose GnRH antagonist protocol

  1. To compare the IVF outcome variables and ongoing pregnancy 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
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Up to three previous IVF attempts

排除标准

  • Patients with poor or no response in previous COH for IVF cycles
  • Abnormal ovarian reserve test i.e. anti-mullerian hormone (AMH), Antral follicle test
  • Risk factor for Diminished Ovarian Reserve

结局指标

主要结局

Ongoing pregnancy rates

时间窗: 2 years

次要结局

  • Total gonadotropin use(2 Years)
  • Biochemical pregnancy(2 Years)
  • Clinical pregnancy(2 Years)
  • Multiple pregnancy rate(2 Years)
  • Miscarriage rate(2 Years)
  • Fertilization rate(2 Years)
  • Number of oocytes(2 years)
  • OHSS rates(2 Years)
  • Embryo quality(2 Years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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