Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment

Inclusion Criteria: * Age between 20 and 38 years with regular menstrual cycles of 25-35 days * First or second cycle in the present series of ART * BMI ≥ 18 ≤ 30 kg/m2 * Basal FSH \< 10 IU/L (cycle day 2-5) * E2 levels \< 50pg/mL (\< 0.18 nmol/L) at the day of FSH administration * Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries) * Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility * Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation) * Willingness to participate in the study and to comply with the study protocol * Informed consent Exclusion Criteria: * Presence of pregnancy * History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy * Presence of clinically significant systemic disease * Presence of chronic cardiovascular, hepatic, renal or pulmonary disease * Presence of uncontrolled endocrine disorder * Previous history or presence of severe ovarian hyperstimulation syndrome * Presence of polycystic ovaries (PCO) * Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx * Neoplasia, including tumors of the hypothalamus and pituitary gland * Abnormal bleeding of undetermined origin * History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt) * Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA) * Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening * Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin) * History of drug, nicotine or alcohol abuse within the last 12 months (\> 10 cigarettes/day) * Administration of other investigational products within the last month * Clinically abnormal findings at Visit 1 * Planned PGS/PGD/PBB or assisted hatching * Concomitant participation in an other study protocol * History of extrauterine pregnancy in the previous 3 months * Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medication (GnRH agonist, vitrelle®, and Utrogestan®) * Presence or history of thrombophlebitis or thromboembolic disorders * Presence or history of cerebral haemorrhage * Presence or history of porphyria