Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technolo… (NCT03738618) | Clinical Trial Compass
CompletedPhase 3
Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)
United States588 participantsStarted 2018-10-29
Plain-language summary
This trial investigates the effects of FE 999049 compared to placebo.
Who can participate
Age range35 Years – 42 Years
SexFEMALE
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Inclusion Criteria:
* Informed Consent Documents signed prior to any trial-related procedure.
* In good physical and mental health in the judgement of the investigator.
* Pre-menopausal women between the ages of 35 and 42 years. The participants must be at least 35 years (including the 35th birthday) when they sign the informed consent and no more than 42 years (up to the day before the 42nd birthday) at the time of randomization.
* Body mass index (BMI) between 17.5 and 38.0 kg/m\^2 (both inclusive) at screening.
* Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
* Documented history of infertility for at least 6 months before randomization (not applicable in case of tubal or severe male factor infertility, or when the use of donor sperm is indicated).
* Regular menstrual cycles of 24-35 days (both inclusive).
* Hysterosalpingography, hysteroscopy or saline infusion sonography, documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous fibroids of any size 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) at screen…
What they're measuring
1
Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (COS)
Timeframe: 8-9 weeks after transfer (up to approximately 16 months after start of stimulation)