OBJECTIVE: To determine the efficacy and safety of Repronex SC as compared with Repronex IM and Pergonal IM in patients undergoing IVF. DESIGN: Open-label, randomized, parallel-group, multicenter study. SETTING:Fifteen academic and private fertility clinics with IVF experience. PATIENT(S): Premenopausal women with regular ovulatory menstrual cycles undergoing IVF for infertility attributable to tubal factors, endometriosis (stage I or II), or unknown factors. INTERVENTION(S): Down-regulation with leuprolide acetate followed by up to 12 days of treatments with gonadotropins, hCG administration, oocyte retrieval, and embryo transplant. MAIN OUTCOME MEASURE(S): Mean number of oocytes retrieved, chemical, clinical, and continuing pregnancies, incidence of oocyte retrieval and embryo transfer, and peak serum E2 concentrations. RESULT(S): There were no significant differences among the treatment groups except for a higher percentage of continuing pregnancies in the Repronex SC group. Gonadotropin therapy was well tolerated in all three treatment groups. The Repronex SC group had a significantly higher incidence of transient mild/moderate injection site reactions during the first few days of therapy. CONCLUSION(S): Repronex SC is comparable in therapeutic effectiveness and safety to Repronex IM and Pergonal IM in patients undergoing IVF and provides an alternative route of injection for self-administration of gonadotropin.
RCT Entities:
OBJECTIVE: To determine the efficacy and safety of Repronex SC as compared with Repronex IM and Pergonal IM in patients undergoing IVF. DESIGN: Open-label, randomized, parallel-group, multicenter study. SETTING: Fifteen academic and private fertility clinics with IVF experience. PATIENT(S): Premenopausal women with regular ovulatory menstrual cycles undergoing IVF for infertility attributable to tubal factors, endometriosis (stage I or II), or unknown factors. INTERVENTION(S): Down-regulation with leuprolide acetate followed by up to 12 days of treatments with gonadotropins, hCG administration, oocyte retrieval, and embryo transplant. MAIN OUTCOME MEASURE(S): Mean number of oocytes retrieved, chemical, clinical, and continuing pregnancies, incidence of oocyte retrieval and embryo transfer, and peak serum E2 concentrations. RESULT(S): There were no significant differences among the treatment groups except for a higher percentage of continuing pregnancies in the Repronex SC group. Gonadotropin therapy was well tolerated in all three treatment groups. The Repronex SC group had a significantly higher incidence of transient mild/moderate injection site reactions during the first few days of therapy. CONCLUSION(S): Repronex SC is comparable in therapeutic effectiveness and safety to Repronex IM and Pergonal IM in patients undergoing IVF and provides an alternative route of injection for self-administration of gonadotropin.