Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation

Inclusion Criteria: >/=18 and < 40 years old; BMI between 18 and 30 kg/m2; less than 3 previous completed cycles; both ovaries present; regular menstrual cycle of 25-35 days; infertility attributable to a tubal factor, American Fertility Society grade I or II endometriosis, male factor or unexplained factor. within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through hysterosalpingogram, sonohystrogram or hysteroscopic examination; basal FSH level less than 10 IU/L; criteria for hCG administration fulfilled (at least 2 follicles with a diameter of 16 mm or more, with acceptable serum E2 concentration). a male partner with semen analysis within the past 6 months showing acceptable values of seminal parameters, defined as > 3x10 exp 6 spermatozoa/ml; qualified to receive 150 - 300 IU FSH as starting dose. Exclusion Criteria: age < 18 and > o = 40 years; primary ovarian failure or women known as poor responders (i.e. requiring more than 300 IU of FSH as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with an E2 serum concentration < 3'000 pmol/L); ovarian cysts > 20 mm, or enlargement not due to polycystic ovarian syndrome; patients affected by pathologies associated with any contraindication of being pregnant; hypersensitivity to the study medication; any bleeding since stimulation; uncontrolled thyroid or adrenal dysfunction; neoplasias; severe impairment of the renal and/or hepatic functions; use of concomitant medication that might interfere with study evaluations (e.g. nonstudy hormonal medications, prostaglandin inhibitors, psychotropic agents); more than 18 days of FSH stimulation.