A prospective, randomized study to assess the tolerance and efficacy of intramuscular and subcutaneous administration of recombinant follicle-stimulating hormone (Puregon)

To compare local tolerance and clinical efficacy after IM or SC injection of recombinant FSH (Puregon; NV Organon, Oss, The Netherlands). An open-label, prospective, randomized, group-comparative, multicenter study. Twelve IVF clinics in 10 countries. Two hundred eighteen infertile pituitary-suppressed women undergoing IVF-ET were randomized, of whom 195 (IM, n = 77; SC, n = 118) received recombinant FSH. One cycle of controlled ovarian hyperstimulation induced by either IM or SC injection of recombinant FSH, followed by IVF-ET. Local tolerance symptoms, number of oocytes retrieved, ongoing pregnancy rate. The incidences after IM injection of bruising, pain, redness, swelling, and itching were 37.7%, 31.2%, 13.0%, 7.8%, and 6.5%; after SC 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, which could be attributed to the more visible superficial injection site with SC administration. The overall occurrence of local symptoms were 63.6% 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 pregnancy rates per attempt were 27.1% (IM) and 26.1% (SC), respectively. There were no marked differences in local tolerance symptoms and clinical efficacy between IM and SC administration of recombinant FSH. Fertil Steril ® 1997; 67:278-83