Efficacy of Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome: A Randomized, Double-blind and Placebo-controlled Trial

Abstract

Introduction: Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication that arises due to assisted reproductive technologies (ARTs) during infertility treatment. Recently, the use of selective dopamine receptor agonists on D2 receptors (e.g., cabergoline) has been suggested in the prevention of OHSS. The aim of this study was to evaluate the effect of cabergoline in the prevention of OHSS in high-risk patients undergoing ART. Materials and methods: This was a randomized, double-blind, parallel group (cabergoline group and placebo) study. A total of 110 women undergoing in vitro fertilization (IVF)–intracytoplasmic sperm injection procedure using a long agonist protocol with high risk for OHSS were recruited for the study on the day of final trigger. All the patients were followed up every 48 hours for 10 days from the day of the final trigger and clinically assessed with ultrasound and blood tests. The size of ovaries and fluid collection in the pouch of Douglas (POD) was measured with ultrasound. A sample size of 92 subjects was calculated for the study to be powered at 80%. Assuming a drop-out rate of 10%, 110 subjects were enrolled for the study. Results: There was no significant difference observed in the size of right and left ovary, POD fluid volume, total leukocyte count (TLC), and serum estradiol level (E2 level) between both the groups from day 0 to day 8, except packed cell volume. No significant difference was observed in the incidence rate of moderate OHSS between both groups (p = 0.728). The differences in clinical pregnancy rate, implantation rate, and live birth rate were also insignificant. Conclusion: Cabergoline does not reduce the incidence of moderate OHSS when compared with placebo. Large, welldesigned studies are needed to evaluate the effectiveness of cabergoline when used for the prevention of OHSS.