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 recombinant 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 (group I = 60 patients) or u-FSH-HP (group II = 60 patients). All received a fixed dose of FSH for 7 days and on the 8th day of stimulation the doses started to be adapted according to ovarian response. Human chorionic gonadotropin (hCG) at the dose of 5000 IU to 10,000 IU was administered to both groups when at least one follicle presented a diameter > or = 17 mm. The ovarian response did not differ significantly between groups I and II in terms of number of follicles > or = 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 oocytes 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 significantly between treatments (group I = 69.4 +/- 25; group II = 66.5 +/- 23; p = 0.38). No cases of cancellation of ovarian stimulation or of severe ovarian hyperstimulation syndrome occurred in either group. The total number 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 rate (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 who used u-FSH-HP (19.5%, 31.7% and 32.2%, respectively), but the differences 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 not demonstrate significant differences in ovary stimulation with r-FSH versus u-FSH in patients whose indication for assisted reproduction was the male factor.

RCT Entities:   Population Interventions Outcomes