Clinical utility of newly developed highly purified human menopausal gonadotrophins: a randomized controlled trial

The aim of this study was to evaluate the safety and efficacy of IVF-M HP, a newly developed highly purified human menopausal gonadotrophin preparation, for ovarian stimulation in women with infertility undergoing IVF, intracytoplasmic sperm injection (IVF-ICSI) and embryo transfer using a GnRH antagonist protocol. This was a multicentre, randomized, active-controlled, parallel design, open-label, non-inferiority clinical study. Of the 112 patients randomized for treatment using the GnRH antagonist protocol, 111 were treated. No significant difference was found in the number of oocytes retrieved from the IVF-M HP and Menopur groups (13.1 ± 7.6 versus 10.3 ± 6.7, respectively). The lower limit of the one-sided 97.5% confidence interval for the difference between the groups was −0.25, i.e., greater than the pre-defined non-inferiority margin (−5). Therefore, the IVF-M HP treatment was considered non-inferior to Menopur. Furthermore, no significant difference was observed between the groups in the number of good-quality oocytes, leading follicles, good-quality embryos, or in fertilization, implantation, positive beta-HCG and clinical pregnancy rates. The safety analysis revealed that 40.4% and 35.2% in the IVF-M HP and Menopur groups, respectively, reported adverse events. In conclusion, IVF-M HP had comparable clinical efficacy and safety profiles to Menopur.