The Early Versus Standard Administration of Cabergoline to Prevent Ovarian Hyperstimulation Syndrome in Patients With Polycystic Ovary Syndrome Undergoing ICSI Cycles: A Randomized Clinical Trial

Objectives: The effect of cabergoline on reducing the incidence rate of ovarian hyperstimulation syndrome (OHSS) has been confirmed by several studies. Currently, what is discussed in this regard is when cabergoline should be started to be most effective in reducing the occurrence and developing rates of OHSS. Materials and Methods: A clinical trial conducted at Arash Women’s Hospital from March to November 2023 included 200 infertile women with polycystic ovary syndrome (PCOS) at risk of OHSS during in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment. Participants were divided into two groups: the experimental group received cabergoline from the start of GnRH antagonist administration for 15 days, and the control group received cabergoline for eight days after oocyte trigger. Measurements of hematocrit (Hct) percentage, serum creatinine (Cr), sodium (Na), and potassium (K) levels, and abdominal circumference were taken three days after ovum pick-up. The study monitored patients until menstruation and focused on the occurrence and severity of OHSS as primary outcomes. Results: The data analysis showed that the two groups were comparable regarding basic characteristics. In the following, the OHSS rate in the early administration group was significantly lower than the control group (14% vs. 47%, P<0.001). In the study group, the severity of all OHSS cases was mild, while the control group reported a moderate severity of OHSS (P<0.001). Conclusions: Earlier initiation of cabergoline from the time of administration of the GnRH antagonist compared to its initiation from the day of oocyte triggering has more effectively reduced the rate and severity of OHSS and improved patient satisfaction. Trial Registration: The study was registered in the Iranian Registry of Clinical Trials on 2023-05-30 (identifier: IRCT20090526001952N16, https://www.irct.ir) during the recruitment phase.