A randomized, assessor-blind, group-comparative efficacy study to compare the effects of Normegon and Metrodin in infertile female patients undergoing in-vitro fertilization.

A randomized, assessor-blind, group-comparative study was performed to compare the efficacy of Normegon [75 IU follicle stimulating hormone (FSH) and 25 IU luteinizing hormone (LH) and Metrodin (75 IU FSH and <1.25 IU LH) in infertile women undergoing in-vitro fertilization (IVF) and embryo transfer. None of the patients were pituitary-suppressed by means of gonadotrophin-releasing hormone (GnRH)-agonist treatment. They were randomized in blocks of five with a ratio between treatment with Normegon and with Metrodin of 3:2. A total of 158 patients started hormonal treatment, i.e. 93 patients with Normegon and 65 patients with Metrodin and a total of 248 cycles were performed. Evaluation of first treatment cycles included statistical analysis of the total number of ampoules, number of follicles (> or = 14 mm), serum oestradiol concentrations on the day of HCG (10,000 IU) administration, 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 of 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 rate per transfer of all cycles was 21% in the Normegon group and 19% in the Metrodin group. Analysis of completed treatment cycles (n = 90) with premature rises of LH > 10.0 IU/l and/or progesterone > 1.0 ng/l revealed a relatively high incidence (23%) of fertilization failure and poor embryo quality, but the ongoing pregnancy rate per transfer was still 22%.