Clinical Study of Clinical Efficacy and Tolerability of hMG-IBSA s.c.in Women Undergoing COH in an ART Programme (IVF).

Inclusion Criteria:

• Women undergoing ovarian stimulation for IVF with or without ICSI (intracytoplasmic sperm injection) and with the following characteristics:
• Voluntary given informed consent to study participation in writing encompassing consent to data recording and verification procedures;
• > 18/= and < 37 years old;
• BMI between 18 and 28 kg/m2;
• Less than 3 previous completed IVF cycles;
• Basal FSH level less than 10 IU/L once within 6 months prior to the study;
• Within 12 month of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, or sonohysterogram, or hysteroscopic examination or TVUS;
• Normal or clinically insignificant haematology and blood chemistry values.

Exclusion Criteria:

• Primary ovarian failure or women known as poor responders;
• Signs of PCO, according to the Rotterdam Criteria;
• At least one ovary inaccessible for oocyte retrieval;
• One or more ovarian cysts > 10 mm;
• Hydrosalpinx that have not been surgically removed or ligated;
• Stage III or IV endometriosis;
• 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;
• PAP smear III within the last 2 years;
• Severe impairment of the renal and/or hepatic functions;
• Lactation;
• Hyperprolactinaemia;
• Participation in a concurrent clinical trial or in another trial within the past four weeks;
• Use of concomitant medication that might interfere with study evaluations.