The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation

Phase 4

Completed

• Conditions: In Vitro Fertilization
• Interventions: Procedure: the timing cabergoline administration

• Registration Number: NCT01065376
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Brief 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Status Verified: 2011-04
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• the risk of ovarian hyperstimulation syndrome development

Exclusion Criteria

• allergic to cabergoline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
on the day of hCG	the timing cabergoline administration	cabergoline administration for 8 days on the day of hCG.
on the day after oocyte retrieval	the timing cabergoline administration	cabergoline administration for 8 days on the day after oocyte retrieval

Primary Outcome Measures

Name	Time	Method
number of metaphase II oocytes	one year

Secondary Outcome Measures

Name	Time	Method
The incidence of OHSS	one year
embryo quality	one year
pregnancy rate	one year

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan