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Human Reproduction, Vol. 18, No. 8, 1626-1631, August 2003
© 2003 European Society of Human Reproduction and Embryology

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

S. Christin-Maitre1,3, J.N. Hugues3 and on behalf of the Recombinant FSH Study Group*

1 Reproductive Endocrine Unit, EA 1533, Hôpital Saint-Antoine, 75012 Paris and 2 Reproductive Medicine Unit, Hôpital Jean Verdier, 93143 Bondy, France

3 To whom correspondence should be addressed: e-mail: sophie.christin-maitre{at}sat.ap-hop.paris.fr

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®) 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®), 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.

Key words: ovulation induction/polycystic ovary syndrome/recombinant FSH/step-down protocol/step-up protocol

* Members of the Recombinant FSH Study Group in alphabetical order: J.M.Antoine, Paris; C.Avril, Rouen; P.Bouchard, and S.Christin-Maitre, Paris; D.Dewailly, Lille; J.C.Emperaire, Bordeaux; P.Fénichel, Nice; R.Frydman, Clamart; B.Hedon, Montpellier; J.N.Hugues and I.Cedrin-Durnerin, Bondy; M.Leroy, Lille; G.Priou, Rennes; J.C.Sage Grenoble; J.Salat-Baroux and M.Savale, Paris (deceased).


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