The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation

In Vitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065376
• Other study ID #: SKH-8302-99-DR-28
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2010
• Last updated: July 20, 2011
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: April 2011
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

Inclusion Criteria:

• the risk of ovarian hyperstimulation syndrome development

Exclusion Criteria:

• allergic to cabergoline

Study Design

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

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

Procedure:
• the timing cabergoline administration
received 0.5 mg oral cabergoline per day for 8 days on the day of hCG
• the timing cabergoline administration
received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of metaphase II oocytes		one year	No
Secondary	embryo quality		one year	No
Secondary	pregnancy rate		one year	No
Secondary	The incidence of OHSS		one year	No