Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
Condition: Infertility
MeSH terms: Infertility
Intervention: Follitropin alfa
Intervention description: 150IU per day subcutaneously for a maximum of 16 days
Intervention MeSH terms: Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 460.0
Sex: Female
Minimum age: 20 Years
Maximum age: 38 Years
Healthy volunteers: No
Keywords: Assisted reproductive treatment; Superovulation; Follitropin alfa; r-hFSH; AFOLIA

Summary:

      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.
    

Eligibility criteria:

        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