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<p>Abstract</p> <p>Background</p> <p>The safety and tolerability of a new highly purified, urine-derived human menopausal gonadotropin (hMG) preparation [Menopur(R)] was compared with a currently available hMG [Repronex (R)] in women undergoing in vitro fertilization (IVF).</p> <p>Methods</p> <p>This was a randomized, open-label, parallel-group, multicenter study conducted in subjects undergoing IVF. Women (N = 125), 18–39 years of age, underwent pituitary down-regulation with leuprolide acetate beginning 7 days prior to onset of menses and continuing up to the day before hCG administration. Subjects were randomized to receive subcutaneous (SC) Menopur (R) (n = 61) or Repronex (R) SC (n = 64) for a maximum of 12 days. All adverse events (AEs) were recorded and subject self-assessments of injection site reactions were recorded in a daily diary.</p> <p>Results</p> <p>Significantly fewer subjects in the Menopur (R) group reported injection site reactions (P < 0.001) compared to the Repronex (R) group. Overall, there was no statistically significant difference in the incidence of AEs between the two treatment groups.</p> <p>Conclusion</p> <p>Menopur (R) SC offers a greater safety and tolerability profile compared to Repronex (R) SC.</p>