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

作者：Sagnella Francesca^*; Moro Francesca; Lanzone Antonio; Tropea Anna; Martinez Daniela; Capalbo Antonio; Gangale Maria Francesca; Spadoni Valentina; Morciano Andrea; Apa Rosanna

来源：Fertility and Sterility, 2011, 95(2): 689-694.

DOI：10.1016/j.fertnstert.2010.08.044

• HP-hMG
• infertility
• IUI
• ovulation induction
• rFSH

Objective: To demonstrate the noninferiority of highly purified menotropin (HP-hMG) compared with recombinant FSH (rFSH) regarding clinical pregnancy rate (PR) in intrauterine insemination (IUI) cycles.
Design: Prospective randomized noninferiority trial.
Setting: Unit 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. (Fertil Steril(R) 2011;95:689-94.

• 出版日期2011-2