Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers
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.
Ovarian Hyperstimulation Syndrome
|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.|
- 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 ]
- 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 ]
|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)|
Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
Other Name: Dostinex
|Placebo Comparator: Placebo||
1 tablet daily for 8 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535859
|KK Women's and Children's Hospital|
|Singapore, Singapore, 229899|
|Principal Investigator:||Marianne Sybille Hendricks, MBBS, MRCOG||KK Women's and Children's Hospital|