Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers
A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.
2 other identifiers
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2012
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
February 20, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 7, 2018
June 1, 2018
3.2 years
February 15, 2012
August 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The development of moderate or severe OHSS necessitating admission for management of OHSS.
Within 2 weeks after hCG trigger
Secondary Outcomes (4)
The need for abdominal or pleural tap
Within 3 weeks after hCG trigger
Other complications of OHSS (venous thromboembolism, cardiac failure, renal failure, acute respiratory failure, pulmonary oedema and coma)
Within 3 weeks after hCG trigger
Admission into intensive care
Within 3 weeks after hCG trigger
Examination of potential biomarkers for OHSS
1-2 years
Study Arms (2)
Cabergoline
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
Eligibility Criteria
You may qualify if:
- Patients with more than 20 oocytes collected after COH in both gonadotropin-releasing hormone (GnRH) agonist and antagonist cycles
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's and Children's Hospital
Singapore, 229899, Singapore
Related Publications (1)
Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.
PMID: 33851429DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne Sybille Hendricks, MBBS, MRCOG
KK Women's and Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
February 20, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2016
Last Updated
August 7, 2018
Record last verified: 2018-06