Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Intervention: Follitropin alfa (Gonal-f); Follitropin alfa (Primapur)
Intervention description: Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation; Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
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: 118.0
Sex: Female
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: in vitro fertilization

Summary:

      The purpose of this study is to show equivalence with regard to the number of oocytes
      retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing
      IVF/ICSI
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infertility due to tubal factor and/or male factor

          -  Age between 20 and 35 years with regular menstrual cycles of 21-35 days

          -  First or second cycle in the present series of ART

          -  BMI (body mass index) ≥ 18 ≤ 30 kg/m2

          -  Basal FSH (follicle stimulating hormone) < 10 IU/L (cycle day 2-5)

          -  E2 (estradiol) levels < 50pg/mL (cycle day 2)

          -  AMH (anti-mullerian hormone) ≥ 1.0 ng/ml

          -  Antral follicle ≥ 4 to ≤ 15 follicles (both ovaries)

          -  Presence of both ovaries and normal uterine cavity

          -  Informed consent

        Exclusion Criteria:

          -  Presence of pregnancy

          -  Hypersensitivity to follitropin alfa

          -  Ovarian cysts

          -  History of ≥2 succeeding ART (assisted reproductive technology) cycles IVF (in vitro
             fertilization) and/or ICSI (Intracytoplasmic sperm injection) before the study cycle

          -  Previous history of severe ovarian hyperstimulation syndrome

          -  Presence of polycystic ovaries (PCO)

          -  Presence of endometriosis and hydrosalpinx

          -  Presence of uterine disorders

          -  History of poor (< 4 oocytes) or hyper (> 25 oocytes) responses to FSH treatment at
             dose 150 IU and GnRH-antagonist (gonadotropin-releasing hormone) protocol

          -  Premature ovarian failure

          -  Ectopic pregnancy (3 month before the study cycle)

          -  Presence of clinically significant systemic disease

          -  Presence of chronic cardiovascular, hepatic, renal or pulmonary disease

          -  Presence of endocrine disorder

          -  Neoplasia

          -  Male infertility without mobile spermatozoa in the ejaculate, that need MESA
             (Microsurgical epididymal sperm aspiration)/TESE (testicular sperm extraction)/TESA
             (testicular sperm aspiration)

          -  Smoking > 10 cigarettes/day

          -  Narcomania, alcoholism

          -  Planned PGS (preimplantation genetic screeneing) /PGD (preimplantation genetic
             diagnosis)