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 follicle stimulating hormone (FSH) in routine clinical use, ovarian stimulation with recombinant human FSH was performed in 71 patients prior to in-vitro fertilization (IVF) without gonadotrophin-releasing hormone (GnRH) analogues in a multicentre, non-comparative study. Human chorionic gonadotrophin (HCG) was administered to 58 patients (81.7%), 15 of whom underwent 19 cycles with an initial dosage of three ampoules daily of recombinant FSH and 43 of whom underwent 152 cycles with four ampoules daily from day 3 onwards. No significant differences were detected between these two groups in all test parameters. The mean duration of 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 number of 6.26 and 5.88 oocytes respectively was collected. The number of 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% respectively). Local tolerance of s.c. administration was excellent. Mild pain at the injection site was the dominant finding in < 20% of patients. Two cases of ovarian hyperstimulation syndrome were noted. Recombinant human FSH is very attractive to patients because it can be self-administered s.c. and the preparation does not come from a human source. In conclusion, these data support the safety and efficacy of recombinant human FSH in routine use for IVF.
Strowitzki
T
T
Department of Obstetrics and Gynaecology, University of Munich, Germany.
Kentenich
H
H
Kiesel
L
L
Neulen
J
J
Bilger
W
W
D000293:Adolescent; D000328:Adult; D004361:Drug Tolerance; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage* / Q000009:adverse effects; D043373:Follicle Stimulating Hormone, Human; D006801:Humans; D007279:Injections, Subcutaneous; D016471:Ovarian Hyperstimulation Syndrome / Q000209:etiology; D010062:Ovulation Induction / Q000009:adverse effects / Q000379:methods*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012449:Safety; D012646:Self Administration
D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone