Clinical Trials Directory

Trials / Completed

CompletedNCT01065376

The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital · Academic / Other
Sex
Female
Age
20 Years – 38 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREthe timing cabergoline administrationreceived 0.5 mg oral cabergoline per day for 8 days on the day of hCG
PROCEDUREthe timing cabergoline administrationreceived 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval

Timeline

Start date
2010-01-01
Primary completion
2011-06-01
Completion
2011-07-01
First posted
2010-02-09
Last updated
2011-07-21

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT01065376. Inclusion in this directory is not an endorsement.