This trial is active, not recruiting.

Condition ovarian hyperstimulation syndrome
Treatments cabergoline, placebo
Phase phase 3
Sponsor KK Women's and Children's Hospital
Start date April 2012
End date June 2015
Trial size 540 participants
Trial identifier NCT01535859, KNMRCNIG1031, NMRC/NIG/1029/2010


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
cabergoline Dostinex
Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
(Placebo Comparator)
1 tablet daily for 8 days.

Primary Outcomes

The development of moderate or severe OHSS necessitating admission for management of OHSS.
time frame: Within 2 weeks after hCG trigger

Secondary Outcomes

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

Eligibility Criteria

Female participants from 21 years up to 45 years old.

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

Additional Information

Official title A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.
Principal investigator Marianne Sybille Hendricks, MBBS, MRCOG
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: 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by KK Women's and Children's Hospital.