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Submitted on February 27, 2007
Accepted on April 16, 2007
Instituto Valenciano de Infertilidad (IVI), University of Valencia, (CA)(EN-M) (RG), (MF),(CS), (AP); Departments of Obstetrics and Gynecology (AP), and Radiology (LM-B), Hospital Universitario Dr Peset, University of Valencia; and Department of Radiology, Hospital Quirón(LM-B, RS), Valencia, Spain
* To whom correspondence should be addressed. E-mail: apellicer{at}ivi.es.
Context: Ovarian hyperstimulation syndrome (OHSS) results from increased vascular permeability (VP) caused by ovarian hypersecretion of Vascular Endothelial Growth Factor (VEGF), which activates its receptor-2 (VEGFR-2). In animals, the Dopamine receptor 2 (Dp-r2) agonist Cabergoline (Cb2) inactivates VEGFR-2 and prevents increased VP.
Objective: To test if Cb2 reduces VP and prevents OHSS in humans.
Design: Prospective, randomized and double blind study on oocyte donors at risk of developing OHSS (>20 follicles >12 mm developed, and >20 oocytes retrieved).
Interventions: Cb2 0.5 mg/day (n=37) or a placebo (n=32) was administered from the day of hCG (day 0) until day 8. Ascites (a pocket of peritoneal fluid >9 cm2 in lithotomy position), hemoconcentration and serum PRL were recorded. Pharmacokinetic studies with magnetic resonance (MR) employing the transfer constant rate (Ktrans, measure of permeability), and the extravascular extracellular space (
e, marker of cellular leakage), were performed to objectively measure VP.
Results: Hematocrit (p<0.01), hemoglobin (p=0.003) and ascites (p=0.005) were significantly lower on days 4 and 6 after treatment with Cb2 as compared to placebo. The incidence of moderate OHSS was 20.0% and 43.8%, respectively (p=0.04). MR studies showed an increase in VP and extravascular leakage of fluid 5 days after hCG injection that was significantly prevented with Cb2(Ktrans p=0.04 and e p=0.001, respectively).
Conclusions: Given that Cb2 is a well established and safe medication, this study provides proof of concept for the use of Dp agonists in the prevention of OHSS in women undergoing assisted reproduction.
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