Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1
Condition: Infertility
MeSH terms: Infertility
Intervention: Follitropin Delta (FE 999049); Follitropin Alfa (GONAL-F)
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: 1329.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This trial investigates the effects of FE 999049 compared to GONAL-F.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent Documents signed prior to screening evaluations

          -  In good physical and mental health

          -  Pre-menopausal females between the ages of 18 and 40 years

          -  Infertile women diagnosed with tubal infertility, unexplained infertility,
             endometriosis stage I/II or with partners diagnosed with male factor infertility,
             eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection
             (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor

          -  Infertility for at least one year before randomisation for subjects ≤37 years or for
             at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe
             male factor infertility)

          -  The trial cycle will be the subject'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 randomisation

          -  Transvaginal ultrasound documenting presence and adequate visualisation 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
             normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. Both
             ovaries must be accessible for oocyte retrieval.

          -  Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L
             (results obtained within 3 months prior to randomisation)

          -  Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening

        Exclusion Criteria:

          -  Known endometriosis stage III-IV

          -  One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to
             randomisation on stimulation day 1

          -  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 subject or of her partner/sperm donor, as applicable,
             depending on source of sperm used for insemination in this trial.

          -  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.