A prospective, randomized clinical trial comparing 150 IU recombinant follicle stimulating hormone (Puregon (R)) and 225 IU highly purified urinary follicle stimulating hormone (Metrodin-HP (R)) in a fixed-dose regimen in women undergoing ovarian stimulation

A prospective, randomized, open, multicentre (n = 3) study was conducted to compare the efficacy and efficiency of a fixed daily dose of 150 IU (3 x 5 0 IU) recombinant follicle stimulating hormone (recFSH, Puregon(R)) and 225 IU (3 x 75 IU) highly purified urinary FSH (uFSH-HP, Metrodin-HP(R)) in wo men undergoing ovarian stimulation prior to in-vitro fertilization treatmen t. A total of 165 women were treated with FSH, 83 subjects with recFSH and 82 subjects with uFSH-HP, In the recFSH group a mean number of 8.8 oocytes were retrieved, compared with 9.8 in the uFSH-HP group (not statistically s ignificant). In the recFSH group, a significantly lower total dose was requ ired compared to the uFSH-HP group, 1479 versus 2139 IU, respectively (P < 0.0001; 95% confidence interval 747 to -572), Treatment with recFSH resulte d in a significantly higher embryo development rate (69.6 versus 56.2 %; P = 0.003) and more embryos accessible for the embryo freezing programme (3.3 versus 2.0; P = 0.02) compared to uFSH-HP, The vital pregnancy rate per cy cle started was 30.2 versus 28.3% in the recombinant and urinary FSH group, respectively. It is concluded that treatment outcome of a fixed daily dose of 150 IU recFSH is comparable to a fixed daily dose of 225 IU uFSH-HP. Ho wever, a significantly lower total dose was needed in the recFSH group (nea rly 700 IU less).