A prospective, randomized, controlled clinical study of a new subcutaneous, purified, urinary FSH preparation for controlled ovarian hyperstimulation in in vitro fertilization

P. Anserini, M. Costa, V. Remorgida, P. L. Venturini

Research output: Contribution to journalArticlepeer-review

Abstract

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 17β-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.

Original languageEnglish
Pages (from-to)75-80
Number of pages6
JournalGynecological Endocrinology
Volume14
Issue number2
Publication statusPublished - 2000

Keywords

  • Controlled ovarian hyperstimulation (COH)
  • In vitro fertilization (IVF)
  • Urinary gonadotropins

ASJC Scopus subject areas

  • Endocrinology
  • Obstetrics and Gynaecology

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