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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.

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 Summary:

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.

Sponsor: KK Women's and Children's Hospital

Current Primary Outcome: The development of moderate or severe OHSS necessitating admission for management of OHSS. [ Time Frame: Within 2 weeks after hCG trigger ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: KK Women's and Children's Hospital

Dates:
Date Received: February 15, 2012
Date Started: April 2012
Date Completion: December 2016
Last Updated: June 14, 2016
Last Verified: June 2016