Multiple follicular development and ovarian steroidogenesis following subcutaneous administration of a highly purified urinary FSH preparation in pituitary desensitized women undergoing IVF: a multicentre European phase III study.

A multicentre, multinational study was carried out between November 1990 and February 1992 to assess the safety and efficacy of a new highly purified urinary human follicle stimulating hormone (FSH; Metrodin HP) which is practically devoid of luteinizing hormone (LH) activity. Metrodin HP was administered s.c. to stimulate multiple follicular development in women undergoing in-vitro fertilization (IVF) and embryo transfer. A total of 139 women were recruited from 10 participating centres. Of these, 135 underwent pituitary desensitization with a long gonadotrophin-releasing hormone (GnRH) agonist protocol and following determination of ovarian inactivity (mean +/- SD of 12.9 +/- 3.2 days), Metrodin HP s.c. stimulation was started; 122 patients were fully eligible for efficacy analysis and 118 of these (97%) received up to 10,000 IU human chorionic gonadotrophin (HCG) to induce final follicular maturation and timed oocyte recovery. Mean plasma LH concentrations at the beginning of Metrodin HP treatment were 1.6 +/- 0.8 mIU/ml and by the day of HCG administration were significantly (P < 0.001) reduced (1.2 +/- 0.8 mIU/ml). The mean plasma oestradiol and inhibin concentrations on the day of HCG were 6173 +/- 3567 pmol/l and 8.2 +/- 4.4 IU/ml respectively. There was a positive correlation (r = 0.49, P < 0.001) between individual oestradiol and inhibin concentrations on the day of HCG. In the 118 patients who received HCG, the mean number of oocytes recovered was 8.4 +/- 4.7 following stimulation with 36 +/- 10, 75 IU ampoules of Metrodin HP over 12.2 +/- 2.1 days.(ABSTRACT TRUNCATED AT 250 WORDS)