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临床试验/NCT01065376
NCT01065376已完成4 期

The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation in Women Undergoing Assisted Reproduction

Shin Kong Wu Ho-Su Memorial Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
120
试验地点
1
主要终点
number of metaphase II oocytes

研究概览

简要总结

The dopamine agonist cabergoline inhibits phosphorylation of the vascular endothelial growth factor receptor-2(VEGFR-2), which prevent vascular endothelial growth factor (VEGF) overexpression and reduce the severity of Ovarian hyperstimulation syndrome. However, VEGF plays an important role in the growth and maintenance of ovarian follicle and developing embryo by mediating angiogenesis.This study was designed to analyze whether the timing cabergoline administration on the day of human chorionic gonadotropin (hCG) injection or after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction treatment.

详细描述

BACKGROUND:Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation induction. It results from increased vascular permeability caused by ovarian hypersecretion of VEGF), which activates its receptor-2. The dopamine agonist cabergoline inhibits phosphorylation of the receptor VEGFR-2, which prevent VEGF overexpression and reduce the severity of OHSS. However, VEGF plays an important role in the growth and maintenance of ovarian follicle and developing embryo by mediating angiogenesis. In human, cabergoline averts OHSS, but a possible detrimental effect on oocyte maturation has not been explored. This study was designed to analyze whether the timing cabergoline administration on the day of hCG injection or after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction treatment.

PURPOSE: To assess whether the timing cabergoline administration affects metaphase II oocytes numbers, embryo quality, pregnancy outcome and the incidence of OHSS.

METHODS: A prospective randomized study was designed to evaluate the possible of cabergoline affect on oocyte maturation. Women (n=120) under controlled ovarian hyperstimulation with the risk of OHSS (Estradiol(E2)>4000 pg/ml, or >18 follicle, >11 mm development) randomized into two groups. Group I (n=60) received 0.5 mg oral cabergoline per day for 8 days on the day of hCG. Group II (n=60) received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval immediately.

ANTICIPATED RESULTS: No significant differences were seen in the number of metaphase II oocytes, the embryo quality, the pregnancy rate and the incidence 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
None

入排标准

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

入选标准

  • •the risk of ovarian hyperstimulation syndrome development

排除标准

  • •allergic to cabergoline

研究组 & 干预措施

on the day of hCG

Experimental

cabergoline administration for 8 days on the day of hCG.

干预措施: the timing cabergoline administration (Procedure)

on the day after oocyte retrieval

Experimental

cabergoline administration for 8 days on the day after oocyte retrieval

干预措施: the timing cabergoline administration (Procedure)

结局指标

主要结局

number of metaphase II oocytes

时间窗: one year

次要结局

  • embryo quality(one year)
  • pregnancy rate(one year)
  • The incidence of OHSS(one year)

研究者

申办方类型
Other

研究点 (1)

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