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

Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.

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)