The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation

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

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.

Study Overview

• Status: Completed
• Conditions: In Vitro Fertilization
• Intervention / Treatment: Procedure: the timing cabergoline administration; Procedure: the timing cabergoline administration

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• the risk of ovarian hyperstimulation syndrome development

Exclusion Criteria:

• allergic to cabergoline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: on the day of hCG; cabergoline administration for 8 days on the day of hCG.	Procedure: the timing cabergoline administration; received 0.5 mg oral cabergoline per day for 8 days on the day of hCG; Procedure: the timing cabergoline administration; received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval
Experimental: on the day after oocyte retrieval; cabergoline administration for 8 days on the day after oocyte retrieval	Procedure: the timing cabergoline administration; received 0.5 mg oral cabergoline per day for 8 days on the day of hCG; Procedure: the timing cabergoline administration; received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of metaphase II oocytes	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
embryo quality	one year
pregnancy rate	one year
The incidence of OHSS	one year

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Investigators: Study Chair: Jiann-Loung Hwang, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: February 8, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (Estimate): February 9, 2010

Study Record Updates

• Last Update Posted (Estimate): July 21, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: IVF; OHSS; cabergoline
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Cabergoline
• Other Study ID Numbers: SKH-8302-99-DR-28