A comparative randomized multicentric study comparing the step-up versus step-down protocol in polycystic ovary syndrome

BACKGROUND: The aim of the study was to evaluate follicular development and ovulation comparing the low-dose step-up and the step-down protocols, in women with clomiphene citrate (CC)-resistant polycystic ovaries. METHODS: Eighty-three women were randomized, and treated with recombinant (r) FSH (Puregon(R)) using either the step-up (n = 44) or step-down (n = 39) protocol. They were followed up for three cycles unless pregnancy occurred. RESULTS: Monofollicular development occurred in 68.2% of the 85 cycles in the step-up group, as compared with 32% of the 72 cycles in the step-down group (P < 0.0001). Hyperstimulation was statistically less frequent using the step-up procedure (4.7 versus 36%, P < 0.0001). Both protocols used the same number of FSH units per cycle (951 +/- 586 versus 967 +/- 458 in step-up and step-down respectively, P = not significant). However, the duration of ovarian stimulation was statistically different (15.2 +/- 7.0 days in step-up versus 9.7 +/- 3.1 in step-down, P < 0.001). Ovulation was observed in 70.3% of the cycles using the step-up procedure as compared with 51.3% using the step-down procedure (P < 0.01). The cumulative rate of clinical gestations during the study did not differ between the two groups (38.6% in the step-up versus 30.8% in the step-down procedure). CONCLUSIONS: The step-up protocol using rFSH (Puregon(R)), is more efficient in obtaining a monofollicular development and ovulation than the step-down protocol, in women with CC-resistant polycystic ovaries. Although the duration of stimulation is longer, the rate of ovarian hyperstimulation is much lower using the step-up protocol.