Ovarian Hyperstimulation Syndrome and Cabergoline

April 3, 2012 updated by: Assoc. Prof. Emine Seda Guvendag Guven, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss

Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome (OHSS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high risk of OHSS, however the possible mechanism of action has not been clearly known. In experimental studies, inhibition of vascular endothelial growth factor based pathway was proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian hormone (AMH) on cabergoline action in OHSS prevention has not been known.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Development of more than 14 leading follicles larger than 10 mm and serum estradiol more than 3000 pg/ml at the end of ovulation induction with long luteal ovulation induction protocol.
  • Having the criteria of PCOS

Exclusion Criteria:

  • Not having the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cabergoline administered group

The patients in this group will have cabergoline (Dostinex tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days) for prevention of OHSS.

All patients were administered long luteal protocol for ovulation induction.
Drug: Cabergoline
Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days
Other Names:
  • Dostinex
NO_INTERVENTION: Control arm

The patients in the control group had no manipulation for prevention of OHSS and age-, BMI-matched with the active comparator group.

All patients were administered long luteal protocol for ovulation induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentrations of follicular fluid AMH
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentrations of follicular fluid inhibin B
Time Frame: 1 year
1 year
Concentrations of follicular fluid HGF
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Investigators

  • Study Chair: Emine Seda Guvendag Guven, MD, Rize University, Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (ESTIMATE)

April 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESG1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Hyperstimulation Syndrome

Clinical Trials on Cabergoline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe