A prospective randomized noninferiority study comparing recombinant FSH and highly purified menotropin in intrauterine insemination cycles in couples with unexplained infertility and/or mild-moderate male factor

ObjectiveTo demonstrate the noninferiority of highly purified menotropin (HP-hMG) compared with recombinant FSH (rFSH) regarding clinical pregnancy rate (PR) in intrauterine insemination (IUI) cycles.DesignProspective randomized noninferiority trial.SettingUnit of physiopathology of human reproduction, university hospital.Patient(s)Five hundred twenty-three patients with unexplained infertility or mild male infertility undergoing controlled ovarian hyperstimulation for IUI.Intervention(s)Patients were randomized for treatment with rFSH (262 patients) or HP-hMG (261 patients). Insemination was performed 34–36 hours after hCG injection.Main Outcome Measure(s)The primary outcome was clinical pregnancy rate (PR). The secondary outcome was the number of interrupted cycles for high risk of ovarian hyperstimulation syndrome (OHSS) and multiple pregnancy.Result(s)The clinical PR was 19.7% (95% confidence interval [CI] 15.3%–25.1%) in the HP-hMG group and 21.4% (95% CI 16.9%–26.8%) in the rFSH group [absolute difference −1.7% (95% CI −8.6%–5.2%)]; therefore, the noninferiority was demonstrated. The number of interrupted cycles for OHSS risk and multiple pregnancy was significanty higher in the rFSH group, 8.4% (95% CI 5.6%–12.4%) than in the HP-hMG group 1.2% (95% CI 0.4%–3.3%) [absolute difference −7.27% (95% CI −11.3 to −3.7)].Conclusion(s)HP-hMG is not inferior compared with rFSH regarding clinical PR.