Effects of clomiphene citrate for prevention of premature luteinizing hormone surge in those undergoing intrauterine insemination outcome: A randomized, double-blind, placebo-controlled trial

The objective of the study is to determine the effects of clomiphene citrate (CC) on preventing premature luteinizing hormone (LH) surge in infertile patients with polycystic ovary syndrome (PCOS) undergoing intrauterine insemination (IUI). This was a randomized clinical trial being performed at Shiraz Mother and Child Hospital. We included 162 women with PCOS selected for IUI cycles. Patients were randomly allocated to receive 150 mg/day CC from the 8(th) of the cycle though the day of human chorionic gonadotropin (hCG) injection (n = 81) or nothing in the same period (n = 81). Main outcomes included the incidence of premature LH surge, pregnancy rate, abortion and ongoing pregnancy rates, number of maturing follicles, and endometrial thickness. The incidence of premature LH surge was significantly lower in those who received CC (3.0% vs. 14.9%; P = 0.021). The pregnancy rate was 10 (15.1%) and 6 (8.9%) in CC and control groups, respectively (P = 0.342). The ongoing pregnancy rate found to be comparable between two study groups (12.1% vs. 5.9%; P = 0.068). Serum level of estradiol (E(2)) level at the time of hCG administration was significantly higher in those who were treated with CC when compared to control (1153.5 ± 326.4 vs. 943.2 ± 215.3; P < 0.001). Patients who received CC also had higher number of mature follicles >18 mm when compared to controls (3.85 ± 1.3 vs. 2.94 ± 1.01; P < 0.001). Administration of CC from the 8(th) day of the cycle to the day of hCG injection in combination with Gonal-f in infertile patients with CC-resistant PCOS undergoing IUI cycles is associated with decreased incidence of premature LH surge, higher E(2)levels, and higher number of mature ovarian follicles. This protocol is safe and simple and could be considered to be cost-effective.