A Phase III Study to Compare Efficacy and Safety of AFOLIA vs. Gonal-f® in Infertile Women 35 to 42 Years of Age Undergoing in Vitro Fertilization (IVF) (FIN3002)

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 follicles with a diameter of <11 mm (both ovaries combined) as measured on US in the early follicular phase (menstrual cycle day 2-5)
• History of >2 unsuccessful fresh ART retrieval cycles
• Presence of uncontrolled endocrine disorder
• Previous history or presence of severe OHSS
• Intrauterine fibroids ≥5 cm or otherwise clinically relevant pathology that could impair embryo implantation or pregnancy continuation
• History of recurrent spontaneous abortion (3 or more, even when unexplained)
• Presence of severe endometriosis (ASRM stage 3 or stage 4) or hydrosalpinx
• Neoplasia, including tumors of the hypothalamus and pituitary gland
• Abnormal bleeding of undetermined origin
• 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 medications (GnRH agonist, Ovidrel®, and Crinone 8%®)
• History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
• Any hormonal treatment within 1 month before the start of the FSH treatment, with the exception of levothyroxine)
• Egg donor
• Administration of other investigational products within the previous month
• Clinically abnormal findings at Visit 1
• Concomitant participation in another study protocol