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

A Phase III Assessor-blinded Randomized Parallel Group Multi-centre Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Versus Gonal-f) in Women for Assisted Reproductive Treatment

Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved 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