Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers
Primary Purpose
Ovarian Hyperstimulation Syndrome
Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Cabergoline
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome
Eligibility 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
Sites / Locations
- KK Women's and Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cabergoline
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The development of moderate or severe OHSS necessitating admission for management of OHSS.
Secondary Outcome Measures
The need for abdominal or pleural tap
Other complications of OHSS (venous thromboembolism, cardiac failure, renal failure, acute respiratory failure, pulmonary oedema and coma)
Admission into intensive care
Examination of potential biomarkers for OHSS
Full Information
NCT ID
NCT01535859
First Posted
February 15, 2012
Last Updated
August 5, 2018
Sponsor
KK Women's and Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01535859
Brief Title
Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers
Official Title
A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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:
Conduct a randomised double-blind placebo-controlled trial in women at high risk of developing OHSS during a fresh COH-IVF cycle
Investigate the serum and follicular fluid levels for potential biomarkers of OHSS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabergoline
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Other Intervention Name(s)
Dostinex
Intervention Description
Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet daily for 8 days.
Primary Outcome Measure Information:
Title
The development of moderate or severe OHSS necessitating admission for management of OHSS.
Time Frame
Within 2 weeks after hCG trigger
Secondary Outcome Measure Information:
Title
The need for abdominal or pleural tap
Time Frame
Within 3 weeks after hCG trigger
Title
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
Title
Admission into intensive care
Time Frame
Within 3 weeks after hCG trigger
Title
Examination of potential biomarkers for OHSS
Time Frame
1-2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Sybille Hendricks, MBBS, MRCOG
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
33851429
Citation
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.
Results Reference
derived
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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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