跳至主要内容
临床试验/NCT01709942
NCT01709942已完成3 期

Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF

Centre for Endocrinology and Reproductive Medicine, Italy1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
PREGNANCY RATE

研究概览

简要总结

In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.

详细描述

Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For this reason in this study the degarelix was tested in order to minimize the risk of OHSS as well as to improve the pregnancy rate in these patients. The use of long acting GnRH antagonist promotes a deep suppression of LH and consequently the activity of theca cells, which secrete androgens (the precursors of estradiol), and consequently the levels of estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in order to establish the best way to perform controlled hyperstimulation in IVF cycles and minimize the risk of OHSS.

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 (Participant)

入排标准

年龄范围
20 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with PCOS
  • previous OHSS
  • Infertility

排除标准

  • more than 38 years old
  • Body mass index pore than 30
  • other systemic diseases

研究组 & 干预措施

degarelix group

Experimental

group of patients treated with long acting GnRH antagonist

干预措施: degarelix (long acting GnRH antagonist) (Drug)

Cetrorelix 0.25mg

Active Comparator

patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol

干预措施: cetrorelix 0.25mg (Drug)

结局指标

主要结局

PREGNANCY RATE

时间窗: 6 MONTHS

number of ongoing pregnancy obtained in the group

ovarian hyperstimulation syndrome rate

时间窗: 6 MONTHS

incidence of ovarian hyperstimulation syndrome in the groups

次要结局

  • implantation rate(6 months)

研究者

发起方
Centre for Endocrinology and Reproductive Medicine, Italy
申办方类型
Network
责任方
Principal Investigator
主要研究者

Fabio Scarpellini

Principal Investigator

Centre for Endocrinology and Reproductive Medicine, Italy

研究点 (1)

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