Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
Condition: Infertility
MeSH terms: Infertility
Intervention: AFOLIA; Gonal-f® RFF
Intervention description: 225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached; 225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
Intervention MeSH terms: Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 1100.0
Sex: Female
Minimum age: 35 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: IVF; In vitro fertilization; Controlled ovarian stimulation; Follitropin; AFOLIA; Finox

Summary:

      The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle
      stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f®
      RFF.
    

Eligibility criteria:

        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