The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation

NCT ID: NCT01065376

Last Updated: 2011-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

In Vitro Fertilization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

on the day of hCG

cabergoline administration for 8 days on the day of hCG.

Group Type EXPERIMENTAL

the timing cabergoline administration

Intervention Type PROCEDURE

received 0.5 mg oral cabergoline per day for 8 days on the day of hCG

on the day after oocyte retrieval

cabergoline administration for 8 days on the day after oocyte retrieval

Group Type EXPERIMENTAL

the timing cabergoline administration

Intervention Type PROCEDURE

received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

the timing cabergoline administration

received 0.5 mg oral cabergoline per day for 8 days on the day of hCG

Intervention Type PROCEDURE

the timing cabergoline administration

received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* the risk of ovarian hyperstimulation syndrome development

Exclusion Criteria

* allergic to cabergoline
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shin-Kong Wu Ho-Su Memorial Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jiann-Loung Hwang, MD

Role: STUDY_CHAIR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SKH-8302-99-DR-28

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cabergoline Reduces OHSS
NCT00440258 COMPLETED PHASE3
Response of VEGF and AT-II to HCG in PCOS
NCT02265861 COMPLETED EARLY_PHASE1