Subcutaneously administered Repronex (R)(a) in oligoovulatory female patients undergoing ovulation induction is as effective and well tolerated as intramuscular human menopausal gonadotropin treatment

Objective: To determine the efficacy and safety of Repronex SC as compared with Repronex IM and Pergonal IM in patients undergoing ovulation induction . Design: Randomized, open-label, multicenter, parallel group study. Setting: Ten academic and private fertility clinics with expertise in ovual tion induction. Patient(s): Premenopausal anovulatory and oligoovulatory females (n = 115) undergoing ovulation induction. Intervention(s): Down-regulation with leuprolide acetate followed by up to 12 days of treatment with gonadotropins and hCG administration and luteal p hase progesterone support. Main Outcome Measure(s): Percentage of patients ovulating; percentage of cy cles with follicular development meeting criteria for hCG administration; n umber of follicles recruited per cycle meeting hCG criteria; peak serum E-2 levels; rates of chemical, clinical and ongoing pregnancies; adverse event s; injection-site pain scores. Result(s): There was no statistically significant difference in the percent age of women who ovulated among the treatment groups. However, Repronex SC was significantly more effective than Pergonal IM in producing follicular d evelopment in patients who met hCG criteria. There were no significant diff erences in clinical, ongoing or continuing pregnancy rates or in multiple p regnancies among the treatment groups. No differences were found in the saf ety assessments, proportions or seriousness of adverse events or treatment discontinuations. Also, there were no differences between the three treatme nt groups in patient-recorded scores of injection-site pain or injection-si te reactions. Conclusion(s): Repronex SC is as efficacious and well tolerated as Repronex IM or Pergonal IM in ovulation induction. Self-administration of Repronex SC provides a convenient treatment alternative to daily IM injections. (C) 2001 by American Society for Reproductive Medicine.