Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers
|ClinicalTrials.gov Identifier: NCT01535859|
Recruitment Status : Active, not recruiting
First Posted : February 20, 2012
Last Update Posted : June 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Hyperstimulation Syndrome||Drug: Cabergoline Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||April 2012|
|Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||December 2016|
Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
Other Name: Dostinex
|Placebo Comparator: Placebo||
1 tablet daily for 8 days.
- The development of moderate or severe OHSS necessitating admission for management of OHSS. [ Time Frame: Within 2 weeks after hCG trigger ]
- The need for abdominal or pleural tap [ Time Frame: Within 3 weeks after hCG trigger ]
- 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 ]
- Admission into intensive care [ Time Frame: Within 3 weeks after hCG trigger ]
- Examination of potential biomarkers for OHSS [ Time Frame: 1-2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|