OVARIAN STIMULATION IN WOMEN UNDERGOING IN-VITRO FERTILIZATION AND EMBRYO-TRANSFER USING RECOMBINANT HUMAN FOLLICLE-STIMULATING-HORMONE (GONAL-F) IN NON-DOWN-REGULATED CYCLES

In order to assess the efficacy and safety of recombinant human follic le stimulating hormone (FSH) in routine clinical use, ovarian stimulat ion with recombinant human FSH was performed in 71 patients prior to i n-vitro fertilization (IVF) without gonadotrophin-releasing hormone (G nRH) analogues in a multicentre, non-comparative study. Human chorioni c gonadotrophin (HCG) was administered to 58 patients (81.7%), 15 of w hom underwent 19 cycles with an initial dosage of three ampoules daily of recombinant FSH and 43 of whom underwent 152 cycles with four ampo ules daily from day 3 onwards, No significant differences were detecte d between these two groups in all test parameters, The mean duration o f treatment was 9.06 and 8.86 days respectively with a mean number of 24.06 and 23.25 vials of recombinant human FSH administered. A mean nu mber of 6.26 and 5.88 oocytes respectively was collected. The number o f transferred embryos was 2.4 and 2.2. A clinical pregnancy rate of 23 .8% (10 out of 42) per transfer was achieved (30.9 and 20.6% respectiv ely). Local tolerance of s.c. administration was excellent. Mild pain at the injection site was the dominant finding in <20% of patients, Tw o cases of ovarian hyperstimulation syndrome were noted, Recombinant h uman FSH is very attractive to patients because it can be self-adminis tered s.c. and the preparation does not come from a human source. In c onclusion, these data support the safety and efficacy of recombinant h uman FSH in routine use for IVF.