A Group-Comparative, Randomized, Double-Blind Comparison of the Efficacy and Efficiency of Two Fixed Daily Dose Regimens (100- and 200-IU) of Recombinant Follicle Stimulating Hormone (rFSH, Puregon®) in Asian Women Undergoing Ovarian Stimulation for IVF/ICSI

Abstract

Purpose : To compare the efficacy, efficacy and safety of a fixed daily dose of recombinant FSH (Puregon®) of a 100- and 200-IU regimen in Asian women undergoing ovarian stimulation for IVF/ICSI. Methods : This was a prospective, randomized, double-blind, multicenter (n = 9) study. Prior to the start of rFSH, all women were pretreated with a gonadotropin releasing hormone agonist (GnRH-a) for pituitary downregulation. Results : A total of 330 women were treated with rFSH: 163 subjects with 100 IU and 167 subjects with . In the 200 IU treatment group, significantly more oocytes were retrieved compared to the 100 IU group (9.6 vs. 5.0 oocytes, p < 0.001). The total dose rFSH needed to develop at least three follicles with a diameter of ≥17 mm was significantly lower in the 100 IU treatment group (1194 vs. 2034 IU, p < 0.001). Although more cycle cancellations were seen in the 100 IU group (24 vs. 13%), the ongoing pregnancy rate per started cycle was comparable between both groups (16.6% in the 100 IU group vs. 15.0% in the 200 IU group). Conclusions : The use of a 100 IU fixed dose is less effective in terms of the number of oocytes retrieved and the higher cancellation rate, but more efficient as indicated by a lower total recombinant FSH dose needed.