A prospective, randomized, double-blind clinical trial to study the efficacy and efficiency of a fixed dose of recombinant follicle stimulating hormone (Puregon (R)) in women undergoing ovarian stimulation

A prospective, randomized, double-blind, multicentre (n = 5) study was cond ucted to compare the influence of either a 100 or 200 IU daily fixed-dose r egimen of recombinant follicle stimulating hormone (FSH) on the number of o ocytes retrieved and the total dose used in down-regulated women undergoing ovarian stimulation. Fertilization was done by intracytoplasmic sperm inje ction or conventional in-vitro fertilization. A total of 199 women were tre ated with FSH, 101 subjects with 100 IU and 98 subjects with 200 IU, In sub jects of the 200 IU treatment group, significantly more oocytes were retrie ved compared to the 100 IU group (10.6 versus 6.2 oocytes, P < 0.001). The total dose needed to develop at least three follicles with a diameter of gr eater than or equal to 17 mm was significantly lower in the 100 TCT treatme nt group (1114 IU versus 1931 IU, P < 0.001). In the low-dose group, signif icantly lower serum concentrations of oestradiol, progesterone and FSH were observed at the day of human chorionic gonadotrophin administration. Altho ugh more cycle cancellations due to Low response were seen in the 100 IU gr oup (n = 24 versus n = 3), the clinical pregnancy rate per started cycle wa s similar (24.7% in the 100 IU group versus 23.3% in the 200 IU group). In the high-dose group, more side-effects, in particular more cases of ovarian hyperstimulation syndrome, were noted. It is concluded that compared to 20 0 IU, the use of a 100 IU fixed dose is less efficacious in terms of the nu mber of oocytes retrieved, but more efficient as indicated by a lower total dose.