Extending clomiphene treatment in clomiphene-resistant women with PCOS: a randomized controlled trial.

The purpose of this study was to test the effect of extended clomiphene citrate treatment compared with gonadotrophin therapy for the management of clomiphene-resistant women with polycystic ovary syndrome (PCOS). The study comprised 318 women (802 cycles) with clomiphene-resistant PCOS randomized to two treatment groups. Patients in the clomiphene citrate group were given 100 mg of clomiphene citrate daily starting on day 2 of menses for 9 days (160 patients, 405 cycles) while patients in the gonadotrophin group were given human menopausal gonadotrophin 75 IU intramuscularly daily for 5 days starting on day 3 of menses (158 patients, 397 cycles). The number of ovulating patients was significantly higher (P = 0.001) in the gonadotrophin group (57.6 versus 28.1%). The total number of follicles during stimulation was significantly greater (P = 0.01) in the gonadotrophin group (6.7 +/- 0.3 versus 4.1 +/- 0.4). Pregnancy occurred in 46/405 cycles in the clomiphene citrate group (11.4%) and in 80/397 cycles (20.2%) in the gonadotrophin group; the difference was statistically significant (P = 0.03). The extended clomiphene citrate regimen resulted in modest ovulation and pregnancy rates with no side effects. This therapy seems to offer economic, efficacy and safety advantages and it is worth undergoing before starting more expensive or sophisticated alternatives.

RCT Entities:   Population Interventions Outcomes