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.