Efficacy of recombinant versus human derived follicle stimulating hormone on the oocyte and embryo quality in IVF-ICSI cycles: Randomised, controlled, multi-centre trial

Abstract

The aim of this trial, comparing human follicle stimulating hormone (hFSH) and recombinant FSH (rFSH) was to evaluate the efficacy on oocyte and embryo quality in in vitro fertilisation/intracytoplasmic sperm injection cycles. Four-hundred and one women were randomised in two groups to receive or hFSH or rFSH in stimulation protocols. The primary end point of this study was the oocyte/embryo quality. No significant difference in oocyte/embryo quality was observed between the two groups. The number of oocytes retrieved was significantly higher in the hFSH group (6 +/- 2.8 in hFSH group vs. 5 +/- 2.6 in rFSH group; P = 0.003). A less amounts of gonadotropins consumed (2106 +/- 719 IU in hFSH group vs. 3536 +/- 1099 IU in rFSH group; P < 0.0001) and shorter duration of stimulation (human chorionic gonadotropin day of administration: Day 12.3 +/- 1.0 in hFSH and Day 13.3 +/- 1.2 in rFSH group, respectively; P < 0.0001) was registered in hFSH group. Fertilisation, cleavage and implantation rates, pregnancy and abortion rates were similar in both groups. However, lower clinical abortion rate (not significant) in hFSH group might be noteworthy. In our study, we demonstrated that hFSH and rFSH products are equivalent in terms of clinical efficacy.