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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01065376
Study type Interventional
Source Shin Kong Wu Ho-Su Memorial Hospital
Contact
Status Completed
Phase Phase 4
Start date January 2010
Completion date July 2011

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