Comparison of two recombinant follicle-stimulating hormone preparations in in-vitro fertilization: a randomized clinical study

A randomized comparison of two recombinant human follicle-stimulating hormone (recFSH) preparations (Gonal-F® and Puregon®) in ovarian stimulation for in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was carried out at the Infertility Clinic of the Family Federation of Finland. A total of 348 women (aged 22-43 years) suffering from infertility due to miscellaneous causes was recruited. Of these, 344 underwent stimulation using equal starting doses (150 IU/day: Gonal-F® n = 164, Puregon® n = 158 or 300 IU/day: Gonal-F® n = 8, Puregon® n = 14) after down-regulation with intranasal buserelin from the mid-luteal phase. Similar clinical pregnancy rates were achieved with both preparations; 33.5% per cycle and 37.4% per embryo transfer (24.5% one-embryo and 75.5% two-embryo transfers, n = 147) with Gonal-F® (150 IU/day) and 32.9% per cycle and 36.4% per embryo transfer (30.1% one-embryo and 69.9% two-embryo transfers, n = 145) with Puregon® (150 IU/day). The ongoing cumulative pregnancy rates after frozenthawed embryo transfer were 35.4% with Gonal-F® and 37.7% with Puregon®. Six cycles were cancelled because of a low response (three in each group). Similar numbers of oocytes were obtained in both groups; 13.0 with 150 IU/ day and 6.1 with 300 IU/day Gonal-F®, and 12.4 with 150 IU/day and 7.1 with 300 IU/day Puregon®. The fertilization and cleavage rates and the incidence of moderate or severe ovarian hyperstimulation syndrome (Gonal-F®, 2.0% and Puregon®, 0.7%) were also similar. Gonal-F® and Puregon® were equally and highly effective in stimulation for IVF and ICSI.