A prospective, randomized, controlled clinical study of a new subcutaneous, purified, urinary FSH preparation for controlled ovarian hyperstimulation in in vitro fertilization.
The aim of this study was to evaluate the clinical efficacy and safety of a new urinary follicle stimulating hormone (FSH) preparation (Fostimon) in patients undergoing in vitro fertilization-embryo transfer or intracytoplasmic sperm injection. Metrodin HP was adopted as a reference drug, as its purity and therapeutic efficacy are well known. Sixty normo-ovulatory patients aged 18-38 years with normal basal FSH and body mass index < 25 kg/m2 were selected for the study. After gonadotropin releasing hormone analogue pituitary desensitization, patients were randomized to receive either Fostimon or Metrodin HP at the initial dosage of 225 IU for 6 days. Thereafter, the dosage was tailored according to the ovarian response. Both drugs were administered by the subcutaneous route. The primary end-points were: number of follicles larger than 15 mm, levels of 17 beta-estradiol on the day of human chorionic gonadotropin (hCG) injection and number of oocytes recovered. The secondary end-points were: number of FSH ampules used, day of hCG injection and pregnancy rate. FSH kinetic curves were calculated during the treatment period with both products. Safety was evaluated by pre- and post-treatment blood biochemistry and hematology, and recording all side-effects. Local tolerance was investigated at each visit. None of the parameters evaluated showed a statistically significant difference between the two groups. Local tolerance was always recorded as good/excellent by both the patients and the physician. In conclusion, Fostimon proved to be an effective and safe drug for assisted reproductive cycles.
Anserini
P
P
Department of Obstetrics and Gynecology, University of Genoa, Italy.
Costa
M
M
Remorgida
V
V
Venturini
P L
PL
D000293:Adolescent; D000328:Adult; D015992:Body Mass Index; D006063:Chorionic Gonadotropin / Q000008:administration & dosage; D004624:Embryo Transfer; D004958:Estradiol / Q000097:blood; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage / Q000627:therapeutic use*; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007279:Injections, Subcutaneous; D008596:Menotropins / Q000627:therapeutic use; D010062:Ovulation Induction; D011247:Pregnancy; D011446:Prospective Studies; D020554:Sperm Injections, Intracytoplasmic
D006063:Chorionic Gonadotropin; D005300:Fertility Agents, Female; D004958:Estradiol; D008596:Menotropins; D005640:Follicle Stimulating Hormone