A Phase II, Multicentre, Multinational, Randomised, Assessor-Blind Trial to Investigate the Efficacy and Safety of Various Dosages of FSH-GEX™ in Comparison With 150 IU Gonal-f® in Women Undergoing ICSI Treatment

Date de début de l'étude : 8 janvier 2013

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