A PROSPECTIVE, RANDOMIZED STUDY TO ASSESS THE TOLERANCE AND EFFICACY OF INTRAMUSCULAR AND SUBCUTANEOUS ADMINISTRATION OF RECOMBINANT FOLLICLE-STIMULATING-HORMONE (PUREGON-ASTERISK)

Objective: To compare local tolerance and clinical efficacy after IM o r SC injection of recombinant FSH (Puregon; NV Organon, Oss, the Nethe rlands). Design: An open-label, prospective, randomized, group-compara tive, multicenter study. Setting: Twelve IVF clinics in 10 countries. Patient(s): Two hundred eighteen infertile pituitary-suppressed women undergoing IVF-ET were randomized, of whom 195 (IM, n = 77; SC, n = 11 8) received recombinant FSH. Intervention(s): One cycle of controlled ovarian hyperstimulation induced by either IM or SC injection of recom binant FSH, followed by IVF-ET. Main Outcome Measure(s): Local toleran ce symptoms, number of oocytes retrieved, ongoing pregnancy rate. Resu lt(s): The incidences after IM injection of bruising, pain, redness, s welling, and itching were 37.7%, 31.2%, 13.0%, 7.8%, and 6.5%; after S C injection, the corresponding figures were 54.2%, 28.0%, 16.1%, 5.9%, and 3.4%. Only bruising was significantly lower in the IM group, whic h could be attributed to the more visible superficial injection site w ith SC administration. The overall occurrence of local symptoms were 6 3.6% after IM injection and 68.6% after SC injection. The mean numbers of oocytes recovered were 9.8 (IM) and 10.4 (SC) and the ongoing preg nancy rates per attempt were 27.1% (IM) and 26.1% (SC), respectively. Conclusion(s): There were no marked differences in local tolerance sym ptoms and clinical efficacy between IM and SC administration of recomb inant FSH. (C) 1996 by American Society for Reproductive Medicine.