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Objectives: This study compares the efficacy and patient tolerance of follitropin-β (recagon) administered using a pen device with conventional syringe in infertile couples undergoing in vitro fertilization/intracytoplasmic sperm injection treatment. Methods: Data for 481 patients were retrieved retrospectively for the analysis. Conventional syringe group constituted 204 patients with 217 cycles and 265 patients with 294 cycles in the pen-device group. Down-regulation was achieved with GnRH agonist. Results: Comparison of follitropin-β administered with pen and syringe showed the following data, respectively. A total dose of 1909·38/2100·65 IU ( P < 0·001), duration of stimulation, 9·70/10·47 days ( P < 0·05), oestradiol levels on the day of human chorionic gonadotropin, 1488·34/1067·63 pg/ml, number of follicles reaching >16-mm size, 9·75/7·34 ( P < 0·05), number of oocytes retrieved, 13·84/9·55 ( P < 0·001) and number of embryos available for freezing, 4·56/1·30 ( P < 0·05), the above data were observed in pen/conventional syringe groups, respectively. The live birth rates per cycle were 28·85% and 30·95% in the conventional syringe/pen-device groups, respectively. Patient tolerance with respect to pain at injection site was better with the pen device ( P < 0·025). Conclusion: The data show that follitropin-β administered with pen device is well tolerated and more efficacious with respect to ovarian stimulation outcome compared with the conventional syringe. [ABSTRACT FROM AUTHOR]