Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

Inclusion Criteria: * Women undergoing ovarian stimulation for IVF with the following characteristics: * Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule * \>18 and \<40 years old * BMI between 18 and 30 kg/m2 * less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery) * basal FSH \<10 IU/L and E2 \<80 pg/ml (\~290 pmol/l) * Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination * Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness \< 7mm or serum E2 level \<50 pg/ml (\~185 pmol/l). Exclusion Criteria: * age \<18 and \>40 years * primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration \<500pg/ml (\~1800 pmol/l)) * PCOS * one or both ovaries inaccessible for oocyte retrieval * ovarian cysts \>10 mm * hydrosalpinx that have not been surgically removed or ligated; * stage 3 or 4 endometriosis * oocyte donation * implantation of previously frozen embryos * patients affected by pathologies associated with any contraindication of being pregnant * hypersensitivity to the study medication * abnormal bleeding of undetermined origin * uncontrolled thyroid or adrenal dysfunction * neoplasias * severe impairment of renal and/or hepatic function * use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)