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临床试验/NCT00571870
NCT00571870已完成不适用

Study on the Effect of GnRH Antagonist on hCG Day on Outcomes of Controlled Ovarian Hyperstimulation With GnRH Antagonist Flexible Multiple-dose Protocols

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年11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
状态
已完成
入组人数
80
试验地点
1
主要终点
Maturity of oocytes, fertilization rate, embryo quality

研究概览

简要总结

Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's.

Many years have passed since GnRH antagonists were introduced to prevent premature LH surges during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group. Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve better follicular and embryonic development and to improve the pregnancy rates in COH using GnRH antagonist.

Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with current protocols, we hypothesized that a shorter duration of GnRH antagonist administration might improve outcome.

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
Single (Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Both ovaries present with no morphological abnormalities
  • Normal ovulatory cycle with cycle lengths of between 25 and 35 days
  • Basal serum FSH (day 3) level of < 15 mIU/mL
  • Body mass index (BMI) ranging between 18 and 27 kg/m2

排除标准

  • History of a poor ovarian response
  • Evidence of endocrine abnormalities, such as, hyperprolactinemia, thyroid dysfunction, or polycystic ovary syndrome
  • Hydrosalpinx
  • Severe endometriosis (stage III-IV)

研究组 & 干预措施

A

Active Comparator

Stimulated as conventional protocol

干预措施: cetrorelix acetate (Drug)

B

Experimental

GnRH antagonist stopped one day earlier than conventional protocol

干预措施: cetrorelix acetate (Drug)

结局指标

主要结局

Maturity of oocytes, fertilization rate, embryo quality

时间窗: 3 days

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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