Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

February 9, 2012 updated by: Roberto Matorras, Hospital de Cruces

Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch

The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF) cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women undergoing IVF cycles with GnRH agonist protocols, at risk of OHSS (more than 20 follicles observed larger than 12 mm in diameter and/or estradiol levels of 3000-5000 pg/mL).

Slow infusion of 500 ml of 6% HES during follicular aspiration alone or combined with 0.5 mg cabergoline administration for 8 days, starting on the day of hCG administration.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Early Phase 1

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • to be at risk of OHSS were invited to participate in the study

Exclusion Criteria:

  • age > 40 years

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Hemoes
Experimental: Cabergoline
cabergoline
Drug: Cabergoline and Hydroxyethyl Starch
0.5mg
Other Names:
  • Dostinex
Drug: Hydroxyethyl Starch
0.5 mg cabergoline administration 8 days
Other Names:
  • Hemoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
risk of ovarian hyperstimulation syndrome
Time Frame: 12 days
12 days

Secondary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: 15 days
15 days

Collaborators and Investigators

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

Sponsor

Hospital de Cruces

Investigators

  • Principal Investigator: Roberto Matorras, MD, PhD, Hospital Cruces

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2012

Last Update Submitted That Met QC Criteria

February 9, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC0754

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.

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