Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)
Condition: Infertility
MeSH terms: Infertility
Intervention: MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL; MENOPUR powder and solvent for solution for injection, 75 IU; Placebo (for MENOPUR solution for injection in pre-filled pen); Placebo (for MENOPUR powder and solvent for solution for injection)
Intervention description: Solution for injection in pre-filled pen, subcutaneous administration; Solution for injection in vials (powder and diluent), subcutaneous administration; Solution for injection in pre-filled pen, subcutaneous administration; Solution for injection in vials (powder and diluent); subcutaneous administration
Intervention MeSH terms: Pharmaceutical Solutions; Menotropins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 405.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: Controlled Ovarian Stimulation; Assisted Reproductive Technology

Summary:

      Development of multiple follicles and pregnancy in ovulatory women undergoing controlled
      ovarian stimulation as part of an assisted reproductive technology (ART) cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consents, prior to any trial-related procedure.

          -  Females between the ages of 18 and 42 years. The participants must be at least 18
             years (including the 18th birthday) when they sign the informed consent and no more
             than 42 years (up to the day before the 43rd birthday) at the time of randomization
             who desire pregnancy.

          -  Body mass index (BMI) between 17.5 and 38.0 kg/m^2 (both inclusive) at screening.

          -  Regular menstrual cycles of 24 to 35 days, presumed to be ovulatory.

          -  Documented history of infertility for at least 12 months before randomization for
             women ≤35 years or for at least 6 months for women ≥36 years. Women with documented
             bilateral tubal occlusion or male factor infertility requiring the use of donor sperm
             established as a cause of infertility are eligible at diagnosis.

          -  Early follicular phase (cycle day 2-4) serum FSH level between 1 and 12 IU/L (results
             obtained within 3 months prior to randomization).

          -  Male partner with semen analysis that is at least adequate for intracytoplasmic sperm
             injection (ICSI) at screening or within 6 months prior to the screening date. Partners
             with severe male factors requiring invasive or surgical sperm retrieval may not be
             used. Use of donor sperm is allowed.

          -  At least 1 cycle with no fertility medication immediately prior to screening.

          -  Hysterosalpingography, hysteroscopy, or saline hysterosonogram documenting uterine
             anatomy appropriate for ART at screening or within 12 months prior to screening.

          -  Transvaginal ultrasound documenting presence and adequate visualization of both
             ovaries, without evidence of clinically significant abnormality (e.g., endometrioma ≥3
             cm, no dermoid cysts) and normal adnexa (e.g., no hydrosalpinx) at screening. Both
             ovaries must be accessible for oocyte retrieval.

        Exclusion Criteria:

          -  More than two previous controlled ovarian stimulation cycles for in vitro
             fertilization (IVF)/ICSI

          -  Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).

          -  Oocyte donor or embryo recipient; gestational or surrogate carrier.

          -  Known history of recurrent miscarriage (defined as three consecutive losses after
             ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24
             of pregnancy).

          -  Participant's male partner, with obvious leukospermia (>2 million white blood
             cells/mL) or signs of infection in semen sample within 6 months of the participant's
             screening. If either of these conditions exists, the male should be treated with
             antibiotics and retested prior to the participant's randomization.

          -  Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of
             these events.

          -  Any known endocrine (total testosterone, prolactin and TSH) or metabolic abnormalities
             (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled
             thyroid function disease.

          -  Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
             which would contraindicate the use of gonadotrophins.

          -  Any abnormal finding of clinical chemistry, hematology and vital signs at screening,
             which is judged clinically significant by the investigator.

          -  Pregnancy (negative urine pregnancy test must be documented at screening and prior to
             the first investigational medicinal product [IMP] administration), or contraindication
             to pregnancy.

          -  Hypersensitivity to any active ingredient or excipients in the medicinal products used
             in this trial.