Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
Condition: Infertility
MeSH terms: Infertility
Intervention: Menotropins; Menotropins
Intervention description: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.; Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
Intervention MeSH terms: Menotropins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 270.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety
      of two different subcutaneous hMG preparations when administered to patients undergoing
      controlled ovarian stimulation for IVF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing ovarian stimulation for IVF with the following characteristics:

               -  Able and willing to sign the Patient Consent Form and adhere to the study
                  visitation schedule

               -  >18 and <40 years old

               -  BMI between 18 and 30 kg/m2

               -  less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)

               -  basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l)

               -  Within 12 months of the beginning of the study, uterine cavity consistent with
                  expected normal function as assessed through transvaginal ultrasound,
                  hysterosalpingogram, sonohysterogram or hysteroscopic examination

               -  Successful down-regulation performed with a standard GnRH-Agonist long protocol
                  (Criteria for successful down-regulation: endometrial thickness < 7mm or serum E2
                  level <50 pg/ml (~185 pmol/l).

        Exclusion Criteria:

          -  age <18 and >40 years

          -  primary ovarian failure or women known as poor responders (i.e. requiring more than
             225 IU of hMG as a starting dose in previous treatment cycles or having less than 3
             oocytes retrieved, or with a pre-ovulatory E2 serum concentration <500pg/ml (~1800
             pmol/l))

          -  PCOS

          -  one or both ovaries inaccessible for oocyte retrieval

          -  ovarian cysts >10 mm

          -  hydrosalpinx that have not been surgically removed or ligated;

          -  stage 3 or 4 endometriosis

          -  oocyte donation

          -  implantation of previously frozen embryos

          -  patients affected by pathologies associated with any contraindication of being
             pregnant

          -  hypersensitivity to the study medication

          -  abnormal bleeding of undetermined origin

          -  uncontrolled thyroid or adrenal dysfunction

          -  neoplasias

          -  severe impairment of renal and/or hepatic function

          -  use of concomitant medications that might interfere with study evaluations (e.g.
             non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)