Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
Condition: Infertility
MeSH terms: Infertility
Intervention: Follitropin delta; Follitropin beta
Intervention description: Single daily subcutaneous administration through pre-filled injection pen; Single daily subcutaneous injection in the abdomen
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: 373.0
Sex: Female
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of
      oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent Documents signed prior to any trial-related procedures.

          -  In good physical and mental health.

          -  Japanese females between the ages of 20 and 40 years.

          -  Infertile women diagnosed with tubal infertility, unexplained infertility,
             endometriosis stage I/II (defined by the revised American Society for Reproductive
             Medicine (ASRM) classification) or with partners diagnosed with male factor
             infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm
             injection (ICSI) treatment using ejaculated sperm from male partner.

          -  Infertility for at least 1 year before randomization (not applicable in case of tubal
             or severe male factor infertility).

          -  The trial cycle will be the participant's first controlled ovarian stimulation cycle
             for IVF/ICSI.

          -  Hysterosalpingography, hysteroscopy, saline infusion sonography or transvaginal
             ultrasound documenting a uterus consistent with expected normal function (e.g. no
             evidence of clinically interfering uterine fibroids defined as submucous or intramural
             fibroids larger than 3 cm in diameter, no polyps and no congenital structural
             abnormalities which are associated with a reduced chance of pregnancy) within 1 year
             prior to screening. This also includes women who have been diagnosed with any of the
             above medical conditions but have had them surgically corrected within 1 year prior to
             screening.

          -  Transvaginal ultrasound documenting presence and adequate visualization of both
             ovaries, without evidence of significant abnormality (e.g. no endometrioma greater
             than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and
             fallopian tubes and surrounding tissue without evidence of significant abnormality
             (e.g. no hydrosalpinx) within 1 year prior to screening. Both ovaries must be
             accessible for oocyte retrieval.

          -  Early follicular phase (cycle day 2-4) serum levels of follicle stimulating hormone
             (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to screening).

          -  Body mass index (BMI) between 17.5 and 32.0 kg/m^2 (both inclusive) at screening.

        Exclusion Criteria:

          -  Known endometriosis stage III-IV (defined by the revised ASRM classification).

          -  One or more follicles >10 mm (including cysts) observed on the transvaginal ultrasound
             prior to start of stimulation on stimulation day 1 (puncture of cysts prior
             randomization is allowed).

          -  Known history of recurrent miscarriage (defined as three consecutive losses after
             ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of
             pregnancy).

          -  Known abnormal karyotype of participant or of her partner. In case the sperm
             production is severely impaired (concentration <1 million/mL), normal karyotype,
             including no Y chromosome microdeletion, must be documented.

          -  Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of
             these events.

          -  Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).

          -  Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or
             kidney) which can compromise participation in the trial with the exception of
             controlled thyroid function disease.

          -  Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
             which would contraindicate the use of gonadotropins.