Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®

Inclusion Criteria: * Female patient for whom ICSI treatment is justified * Serum follicle-stimulating hormone concentration * Anti-mullerian hormone concentration * Antral follicle count * Body mass index and body weight * Presence of both ovaries * Regular spontaneous cycles between 21 and 35 days in length * Normal uterine cavity as assessed by transvaginal sonography at Screening * Willing and able to comply with the protocol * Willing and able to provide written informed consent Exclusion Criteria: * Patients who had more than two unsuccessful previous assisted reproduction technology cycles before inclusion into the study * Previous poor responders * Patients with previous hyperstimulation syndrome or cycle cancellation because of imminent hyperstimulation syndrome * Patients with a history of or current polycystic ovarian morphology syndrome * Patients with a history of or current endometriosis III or IV * Presence of ovarian cyst at Screening * Any contraindication to becoming pregnant * History of ≥ 3 clinical or preclinical miscarriages * Abnormal cervical smear, Papanicolaou \[PAP\] score ≥ 3 * Any history of malignant cancer other than in situ breast or skin cancer requiring local excision * Any endocrine abnormalities requiring treatment * Any clinically significant systematic disease * Any known infection with human immunodeficiency virus, hepatitis B or C * History of thrombosis or other risk factors including any coagulation abnormality leading to an increased risk of clotting * Family history of genetic risk factors concerning pregnancy or birth * Use of concomitant medication, which in the opinion of the investigator might interfere with ICSI preparation procedures * Active smoking * Any active substance abuse of drugs, medications or alcohol within the last five years * Patients in an institution by official or court order * Patients who are unable or unwilling to provide informed consent * Any participation in another clinical trial within the last 60 days before randomisation * Previous FSH-GEX™ administration. * Known hypersensitivity to any component of the investigational and non investigational products used in this study