This case report describes the first established pregnancy and birth after ovarian stimulation with Org 32489, pure recombinant human follicle stimulating hormone (recFSH, Organon International). A patient with tubal infertility participated in an open efficacy study of recFSH evaluating the efficacy of combined gonadotrophin-releasing hormone (GnRH)-agonist/recFSH treatment in women undergoing in-vitro fertilization (IVF) and embryo transfer. Ovarian stimulation was induced by recFSH in association with buserelin (Suprecur, 4 x 150 micrograms/day) using a short protocol. After 9 days of recFSH treatment (75 IU/day), six pre-ovulatory follicles (> or = 15 mm) were observed and 10,000 IU human chorionic gonadotrophin were administered. Nine mature oocytes were retrieved by oocyte puncture and after IVF, three embryos were replaced in the uterus. A viable singleton intra-uterine pregnancy was revealed at a gestational age of 7 weeks. The pregnancy progressed normally and ended with a vaginal delivery at a gestational age of 39.5 weeks. A healthy girl was born and paediatric examination did not demonstrate any abnormality.