Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers

August 5, 2018 updated by: KK Women's and Children's Hospital

A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.

The purpose of this study is to determine whether cabergoline is effective in reducing the incidence and severity of Ovarian Hyperstimulation Syndrome (OHSS), especially for severe cases; and to derive biomarkers for the risk of developing OHSS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Severe ovarian hyperstimulation syndrome (OHSS) occurs in up to 2% of in-vitro fertilisation (IVF) cycles, resulting in accumulation of fluid in peritoneal, pleural and pericardial cavities, haemo-concentration with resultant venous thromboembolic phenomena, reduced perfusion of vital organs, renal failure, acute respiratory failure, and even death.

The long term aim is to develop a comprehensive strategy in reducing the incidence and severity of OHSS in in-vitro fertilisation (IVF) cycles. Our short term aim (2-3 years) is to test the ability of the dopamine receptor agonist cabergoline in reducing the incidence and severity of OHSS in high risk women undergoing controlled ovarian hyperstimulation (COH) in fresh IVF cycles through a reduction in vasoactive cytokine levels, specifically in serum vascular-endothelial growth factor (VEGF).

Specifically we will:

  1. Conduct a randomised double-blind placebo-controlled trial in women at high risk of developing OHSS during a fresh COH-IVF cycle
  2. Investigate the serum and follicular fluid levels for potential biomarkers of OHSS.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital

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

17 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with more than 20 oocytes collected after COH in both gonadotropin-releasing hormone (GnRH) agonist and antagonist cycles

Exclusion Criteria:

  • Patients with allergy to dopamine agonists
  • Patients who undergo in-vitro maturation cycles
  • Patients where GnRH analogues have been used to trigger oocyte maturation in antagonist cycles

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
1 tablet daily for 8 days.
Experimental: Cabergoline
Drug: Cabergoline
Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
Other Names:
  • Dostinex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The development of moderate or severe OHSS necessitating admission for management of OHSS.
Time Frame: Within 2 weeks after hCG trigger
Within 2 weeks after hCG trigger

Secondary Outcome Measures

Outcome Measure
Time Frame
The need for abdominal or pleural tap
Time Frame: Within 3 weeks after hCG trigger
Within 3 weeks after hCG trigger
Other complications of OHSS (venous thromboembolism, cardiac failure, renal failure, acute respiratory failure, pulmonary oedema and coma)
Time Frame: Within 3 weeks after hCG trigger
Within 3 weeks after hCG trigger
Admission into intensive care
Time Frame: Within 3 weeks after hCG trigger
Within 3 weeks after hCG trigger
Examination of potential biomarkers for OHSS
Time Frame: 1-2 years
1-2 years

Collaborators and Investigators

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

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Marianne Sybille Hendricks, MBBS, MRCOG, KK Women's and Children's Hospital

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

April 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

February 17, 2012

First Posted (Estimate)

February 20, 2012

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNMRCNIG1031
  • NMRC/NIG/1029/2010 (Other Grant/Funding Number: National Medical Research Council)

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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