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临床试验/NCT00417144
NCT00417144Unknown4 期

Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients

Eugonia2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2003年11月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
发起方
入组人数
200
试验地点
2
主要终点
Development of OHSS

研究概览

简要总结

The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol.

详细描述

Women with polycystic ovarian syndrome (PCOS) represent a group of patients at high risk of developing ovarian hyperstimulation syndrome (OHSS), an iatrogenic complication of ovarian stimulation during IVF treatment. In contrast to mild OHSS, severe OHSS is a life-threatening complication, characterized by massive ovarian enlargement, ascites, pleural effusion, oliguria, haemoconcentration and thromboembolic phenomena. Currently, no curative therapy for OHSS is available and thus prevention is considered the most effective "treatment". Several measures have been adopted to reduce the occurrence of the syndrome, the most effective being cycle cancellation and withholding of human chorionic gonadotropin (hCG), which seems to be the most critical factor for the development of OHSS.

COMPARISON: This study aims to compare the development and severity of OHSS, as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist (Ganirelix) protocol vs a long GnRH agonist (Arvekap) protocol of ovarian stimulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic ovaries)

排除标准

  • Normal responders
  • Poor responders

结局指标

主要结局

Development of OHSS

Ongoing pregnancy rate per embryo transfer

次要结局

  • Biochemical pregnancy
  • Clinical pregnancy
  • Embryological data

研究者

发起方
Eugonia
申办方类型
Other

研究点 (2)

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