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

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01535859
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
50
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
Actual Enrollment :
46 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 :
Apr 1, 2012
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cabergoline

Drug: Cabergoline
Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
Other Names:
  • Dostinex

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    1 tablet daily for 8 days.

    Outcome Measures

    Primary Outcome Measures

    1. The development of moderate or severe OHSS necessitating admission for management of OHSS. [Within 2 weeks after hCG trigger]

    Secondary Outcome Measures

    1. The need for abdominal or pleural tap [Within 3 weeks after hCG trigger]

    2. Other complications of OHSS (venous thromboembolism, cardiac failure, renal failure, acute respiratory failure, pulmonary oedema and coma) [Within 3 weeks after hCG trigger]

    3. Admission into intensive care [Within 3 weeks after hCG trigger]

    4. Examination of potential biomarkers for OHSS [1-2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    KK Women's and Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT01535859
    Other Study ID Numbers:
    • KNMRCNIG1031
    • NMRC/NIG/1029/2010
    First Posted:
    Feb 20, 2012
    Last Update Posted:
    Aug 7, 2018
    Last Verified:
    Jun 1, 2018
    Additional relevant MeSH terms:
    Ovarian Hyperstimulation Syndrome
    Syndrome
    Cabergoline

    Study Results

    No Results Posted as of Aug 7, 2018