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

KK Women's and Children's Hospital

Status and phase: Completed; Phase 3

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: Placebo; Drug: Cabergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT01535859

KNMRCNIG1031

NMRC/NIG/1029/2010 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Cabergoline

Experimental group

Treatment:

Drug: Cabergoline

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo