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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT01535859
First received: February 15, 2012
Last updated: May 8, 2014
Last verified: April 2013
  Purpose

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 Intervention Phase
Ovarian Hyperstimulation Syndrome
Drug: Cabergoline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by KK Women's and Children's Hospital:

Primary Outcome Measures:
  • The development of moderate or severe OHSS necessitating admission for management of OHSS. [ Time Frame: Within 2 weeks after hCG trigger ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The need for abdominal or pleural tap [ Time Frame: Within 3 weeks after hCG trigger ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Admission into intensive care [ Time Frame: Within 3 weeks after hCG trigger ] [ Designated as safety issue: No ]
  • Examination of potential biomarkers for OHSS [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535859

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

No publications provided

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
Study First Received: February 15, 2012
Last Updated: May 8, 2014
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on October 01, 2014