A RANDOMIZED, ASSESSOR-BLIND, GROUP-COMPARATIVE EFFICACY STUDY TO COMPARE THE EFFECTS OF NORMEGON(R) AND METRODIN(R) IN INFERTILE FEMALE-PATIENTS UNDERGOING IN-VITRO FERTILIZATION

A randomized, assessor-blind, group-comparative study was performed to compare the efficacy of Normegon(R) [75 IU follicle stimulating hormo ne (FSH) and 25 IU luteinizing hormone (LH)] and Metrodin(R) (75 IU FS H and <1.25 IU LH) in infertile women undergoing in-vitro fertilizatio n (IVF) and embryo transfer. None of the patients were pituitary-suppr essed by means of gonadotrophin-releasing hormone (GnRH)-agonist treat ment. They were randomized in blocks of five with a ratio between trea tment with Normegon and with Metrodin of 3:2. A total of 158 patients started hormonal treatment, i.e. 93 patients with Normegon and 65 pati ents with Metrodin and a total of 248 cycles were performed. Evaluatio n of first treatment cycles included statistical analysis of the total number of ampoules, number of follicles (greater than or equal to 14 mm), serum oestradiol concentrations on the day of HCG (10 000 IU) adm inistration, the number of oocytes retrieved and the ongoing pregnancy rate per attempt and per transfer. For none of these parameters were significant differences revealed. In both groups the median duration o f stimulation was 7 days and the median number of ampoules used was 21 . Overall, the duration of treatment was short in order to prevent as much as possible endogenous LH rises. The overall ongoing pregnancy ra te per transfer of all cycles was 21% in the Normegon group and 19% in the Metrodin group. Analysis of completed treatment cycles (n = 90) w ith premature rises of LH > 10.0 IU/l and/or progesterone > 1.0 ng/l r evealed a relatively high incidence (23%) of fertilization failure and poor embryo quality, but the ongoing pregnancy rate per transfer was still 22%. These data suggest that premature rises of LH and progester one are deleterious for oocyte quality but may not affect the endocrin e environment of the endometrium. In conclusion, Normegon is an effica cious preparation for the induction of ovarian stimulation in infertil e women undergoing IVF.