Clomiphene citrate plus cabergoline versus clomiphene citrate for induction of ovulation in infertile euprolactinemic patients with polycystic ovary syndrome: A randomized clinical trial

Abstract Objective To compare the effect of adjunctive use of cabergoline with clomiphene citrate (CC) in infertile polycystic ovarian syndrome (PCOS) patients with normal prolactin level. Study design A randomized clinical trial (NCT 02644304). Setting Assiut University Hospital, Assiut, Egypt. Materials and methods Infertile euprolactinemic PCOS patient were recruited and randomized in a 1:1 ratio to CC plus cabergoline or CC alone. All patients were evaluated by ultrasound examination for number, size of ovarian follicles and they were followed up for 3 consecutive cycles. The primary outcome of the study was the cumulative rate of ovulation in both groups allover the 3 cycles of treatment. The secondary outcomes included clinical pregnancy rate, miscarriage rate, multiple pregnancy rate, ovarian hyperstimulation rate and the rate of adverse effects of the study medications. Results One-hundred thirty patients were included (65 in each group). No statistical difference between both groups regarding the basal criteria. The cumulative ovulation rate in the CC plus cabergoline group was 76.7% versus 58.3% in the CC group (p = .032). Additionally, the largest follicle size in each cycle was significantly more in the CC plus cabergoline group (p  Conclusions The use of cabergoline with CC in induction of ovulation in euprolactinemic infertile women with PCOS results in high ovulation rate, high pregnancy rate as compared to use of CC alone.