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

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