Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF

Inclusion Criteria: * 35 to 42 years of age * Indication for controlled ovarian stimulation and IVF or intracytoplasmic sperm injection (ICSI) * Regular menstrual cycles (25-35 days) * History of a maximum of two fresh cycle treatments in the present series of assisted reproductive technologies (ART) at the day of first screening (thawed cycles are not subject to that criteria) * Body mass index (BMI) ≥18 and ≤38 kg/m2 * Basal FSH \<12 IU/L (cycle day 2-5) * Antral follicle count (AFC) ≥ 10 to ≤20 follicles with a diameter of \<11mm (sum of both ovaries) as measured on ultrasound (US) in the early follicular phase (menstrual cycle day 2-5) * Documented history of infertility due to any of the following factors: tubal factor, mild endometriosis (American Society for Reproductive Medicine \[ASRM\] stage 1-2), male factor, unexplained infertility * Presence of both ovaries by ultrasonography and normal uterine cavity (confirmed by hysterosalpingography, saline infusion sonography or hysteroscopy within 6 months before randomization) * Male partner with semen analysis that is at least adequate for ICSI within 6 months prior to patient beginning down-regulation (invasive or surgical sperm retrieval, donor and/or cryopreserved sperm may be used) * Willingness to participate in the study and to comply with the study protocol * Signed informed consent prior to screening Exclusion Criteria: * Presence of pregnancy * History of or active polycystic ovary syndrome (PCOS) * AFC \>20 f…