Expression of Concern: Intrauterine insemination versus timed intercourse with clomiphene citrate in polycystic ovary syndrome: a randomized controlled trial

Objective. To compare the efficacy of intrauterine insemination vs. timed intercourse with clomiphene citrate as a first‐line treatment for anovulatory infertility associated with polycystic ovary syndrome. Design. A randomized controlled trial following the CONSORT criteria. Setting. A university hospital and a private practice setting. Patients. 188 women (525 cycles) with polycystic ovary syndrome. Main outcome measures. Women received three consecutive cycles of ovulation induction with clomiphene citrate and intrauterine insemination ( n =93, 259 cycles) or three consecutive cycles of clomiphene citrate with timed intercourse ( n =95, 266 cycles). Outcome measures. Clinical pregnancy rate per cycle, number of growing and mature follicles, serum estradiol, endometrial thickness at the hCG day, serum progesterone, ovulation, miscarriage and live birth rates. Results. There were no differences between the two groups regarding the clinical pregnancy rate per cycle or per woman (8.49 vs. 7.89% and 23.6 vs. 22.1%; p =0.26 and p =0.33, respectively). Two twin pregnancies occurred in each group. Miscarriage and live birth rates were comparable (18.1 vs. 19% and 19.35 vs. 17.89%; p =0.31 and p =0.33, respectively). No ectopic, higher‐order pregnancies or cases of ovarian hyperstimulation syndrome occurred. No differences were found regarding the number of follicles, serum progesterone, ovulation rates, estradiol levels or endometrial thickness at the hCG day (7.7±0.4 vs. 7.5±0.6mm; p =0.54). Conclusions. Ovulation induction with clomiphene citrate and timed intercourse is as effective as that with intrauterine insemination for achieving pregnancy in polycystic ovary syndrome and could represent the initial treatment option, being less invasive and less expensive than intrauterine insemination.