跳至主要内容
临床试验/NCT01530490
NCT01530490已完成早期 1 期

Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch

Hospital de Cruces0 个研究点目标入组 80 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
80
主要终点
risk of ovarian hyperstimulation syndrome

研究概览

简要总结

The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF) cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.

详细描述

Women undergoing IVF cycles with GnRH agonist protocols, at risk of OHSS (more than 20 follicles observed larger than 12 mm in diameter and/or estradiol levels of 3000-5000 pg/mL).

Slow infusion of 500 ml of 6% HES during follicular aspiration alone or combined with 0.5 mg cabergoline administration for 8 days, starting on the day of hCG administration.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • to be at risk of OHSS were invited to participate in the study

排除标准

  • age > 40 years

研究组 & 干预措施

Cabergoline

Experimental

cabergoline

干预措施: Cabergoline and Hydroxyethyl Starch (Drug)

Cabergoline

Experimental

cabergoline

干预措施: Hydroxyethyl Starch (Drug)

结局指标

主要结局

risk of ovarian hyperstimulation syndrome

时间窗: 12 days

次要结局

  • pregnancy rate(15 days)

研究者

发起方
Hospital de Cruces
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Matorras

Head of reproduction Unit

Hospital de Cruces

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