A prospective and randomized study of ovarian stimulation for ICSI with recombinant FSH versus highly purified urinary FSH

A prospective and randomized study of ovarian stimulation with human recomb inant follicle-stimulating hormone (r-FSH; Gonal-F) versus highly purified urinary FSH (u-FSH-HP; Metrodin-HP) was conducted on patients submitted to an intracytoplasmic sperm injection (ICSI) program. A total of 120 patients aged 37 years or less were stimulated in a randomized manner with r-FSH (g roup I = 60 patients) or u-FSH-HP (group II = 60 patients). All received a fixed dose of FSH for 7 days and on the gth day of stimulation die doses st arted to be adapted according to ovarian response. Human chorionic gonadotr opin (hCG) at the dose of 5000 IU to 10 000 IU was administered to both gro ups when at least one follicle presented a diameter greater than or equal t o 17 mm. The ovarian response did not differ significantly between groups I and II i n terms of number of follicles greater than or equal to 16 mm (group I = 6. 2 +/- 3.2; group II = 6.7 +/- 2.9; p = 0.26), number of oocytes collected ( group I = 10.7 +/- 6.8; group II = 10.5 +/- 5.7; p = 0.91), number of oocyt es in metaphase II (group I = 9.2 +/- 5.8; group II = 8.2 +/- 4.8; p = 0.56 ) or number of immature oocytes (group I = 1.8 +/- 0.9; group II = 1.9 +/- 1.7; p = 0.62). The normal fertilization rate after ICSI did not differ sig nificantly between treatments (group I = 69.4 +/- 25; group II = 66.5 +/- 2 3; p = 0.38). No cases of cancellation of ovarian stimulation or of severe ovarian hyperstimulation syndrome occurred in either group. The total numbe r of embryos obtained from patients who used r-FSH (group I = 6.3 +/- 4.5) was similar (p = 0.46) to the number obtained from patients who used u-FSH- HP (group II = 5.5 +/- 3.7), as also was the number of transferred embryos (group I = 2.8 +/- 0.8; group, II = 2.6 +/- 0.9; p = 0.27). Implantation ra te (26.1%) and clinical pregnancy rates per puncture (36.7%) and per embryo transfer (37.9%) were higher in patients who used r-FSH than in patients w ho used u-FSH-HP (19.5%, 31.7% and 32.2%, respectively), but the difference s were not statistically significant. The abortion rate (p = 0.32) did not differ between groups (group I = 4.5%, n = 1 versus group II = 15.7%, n = 3 ). Thus far, the data do nor demonstrate significant differences in ovary stim ulation with r-FSH versus u-FSH in patients whose indication for assisted r eproduction was the male factor.