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

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ClinicalTrials.gov Identifier: NCT01535859
Recruitment Status : Active, not recruiting
First Posted : February 20, 2012
Last Update Posted : June 15, 2016
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome Drug: Cabergoline Drug: Placebo Phase 3

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  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.
Study Start Date : April 2012
Primary Completion Date : June 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cabergoline Drug: Cabergoline
Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
Other Name: Dostinex
Placebo Comparator: Placebo Drug: Placebo
1 tablet daily for 8 days.

Primary Outcome Measures :
  1. The development of moderate or severe OHSS necessitating admission for management of OHSS. [ Time Frame: Within 2 weeks after hCG trigger ]

Secondary Outcome Measures :
  1. The need for abdominal or pleural tap [ Time Frame: Within 3 weeks after hCG trigger ]
  2. 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 ]
  3. Admission into intensive care [ Time Frame: Within 3 weeks after hCG trigger ]
  4. Examination of potential biomarkers for OHSS [ Time Frame: 1-2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535859

KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Principal Investigator: Marianne Sybille Hendricks, MBBS, MRCOG KK Women's and Children's Hospital

Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT01535859     History of Changes
Other Study ID Numbers: KNMRCNIG1031
NMRC/NIG/1029/2010 ( Other Grant/Funding Number: National Medical Research Council )
First Posted: February 20, 2012    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs