A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
Condition: Infertility
MeSH terms: Infertility
Intervention: Menotrophin; Follitropin alfa
Intervention description: 150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.; 150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
Intervention MeSH terms: Menotropins; Follicle Stimulating Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Female
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Prospective open label, randomised, parallel group, comparative pilot.
    

Eligibility criteria:

        Female patients aged > or = 20 and < or = 35 years with a BMI of >18 and <32 kg/m2 who have
        received no more than two previous cycles of in vitro fertilisation (IVF) or other assisted
        reproductive technique (ART) and whose partners have normal sperm (according to WHO 1999
        criteria).

        Inclusion criteria:

          -  Signed informed consent;

          -  Subfertile premenopausal female patients eligible for IVF treatment;

          -  Aged >=20 and <=35 years;

          -  Body mass index of >18 and <32 kg/m2

          -  Normal endocrine assessment within the last 6 months;

          -  Normal pelvic ultrasound (showing two ovaries, no ovarian abnormalities and normal
             uterus) within the last 6 months;

          -  Receipt of no more than two previous cycles of IVF (or other ART);

          -  At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented
             evidence of ovulatory cycles within the previous 12 months;

          -  No fertility-modifying treatment within the 3 months prior to this treatment cycle;

          -  Infertility attributable to or in association with either tubal factor, or unexplained
             causes;

          -  Sperm of partner classed as normal according to WHO 1999 criteria within the year
             prior to beginning therapy;

          -  Negative serum beta-HCG pregnancy test prior to beginning therapy;

          -  Clinically normal baseline haematology, clinical chemistry, and urinalysis parameter
             values, negative serum HBsAg and HIV antibody tests;

          -  Screening endocrine test results (estradiol, LH, FSH, progesterone, prolactin, TSH) in
             early follicular phase within the normal limits for the clinical laboratory.

        Exclusion criteria

          -  Presence of any clinically relevant systemic disease(e.g. insulin- dependent diabetes
             mellitus);

          -  A history of or current endocrine disease, including polycystic ovary- like syndrome
             and hyperprolactinaemia;

          -  A history of coagulation disorders;

          -  Persistent ovarian cysts;

          -  Contraindications for the use of gonadotrophins or GnRH antagonists;

          -  A history of hypersensitivity to any of the constituents of the study medication or
             related compounds;

          -  Three or more previous cycles of IVF (or other ART);

          -  A history of alcohol abuse (more than 30 units per week on a regular basis);

          -  History of chemo- or radiotherapy;

          -  Currently breast-feeding, pregnant or with a contraindication to pregnancy;

          -  Diagnosed poor responders in prior IVF treatment;

          -  History of severe ovarian hyperstimulation syndrome (OHSS) (4 or 5) in former IVF
             treatment;

          -  Investigational drug within the 30 days prior to treatment;

          -  Any other condition or history that the investigator considers might increase the risk
             to the individual.