Uterine Transplantation for the Treatment of Uterine Factor Infertility (NCT02573415) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Uterine Transplantation for the Treatment of Uterine Factor Infertility
United States10 participantsStarted 2015-10
Plain-language summary
This feasibility study aims to enroll ten subjects who will undergo deceased donor uterine transplantation at Cleveland Clinic. We estimate that fifty to one hundred patients with uterine factor infertility will need to be screened to identify 10 appropriate subjects.
There are seven phases involved in this study: Primary and Secondary Screening, Medical Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Must meet criteria for uterine factor infertility
✓. Prior hysterectomy
✓. Congenital absence or malformation of the uterus preventing pregnancy c, Infertility due to uterine damage from prior injury or infection
✓. Must be between the ages of 21-45 and the embryos must have been produced between the age of 21-39. (age at the time the embryos are produced, not current age)
✓. Must be willing to undergo a psychiatric and social work pre-transplant evaluation
✓. Must be willing to undergo general anesthesia, in vitro fertilization, major gynecologic surgery, pregnancy with potential high risk complications, cesarean delivery and eventual hysterectomy to remove the graft
✓. Must be willing and able to receive potent immunosuppressive medications and must be able to follow standard infection prophylaxis protocols
✓. Must be willing to receive standard vaccinations such as influenza, pneumococcus, human papillomavirus (HPV) and hepatitis B
Exclusion criteria
✕. History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease
✕. Any medical diagnosis placing the subject at high risk of surgical complications based on the transplant team's review of medical history.
✕. Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
What they're measuring
1
Number of successful live births after uterus transplant and IVF
✕. History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years.
✕. Human immunodeficiency virus, mycobacteria, hepatitis B (Hepatitis risk is for those with hepatitis B (HB) surface and/or core antigen and/or hepatitis B virus (HBV) DNA positive. Thos that are HB core antibody positive are at minimal risk and everyone else is not at risk), or hepatitis C.
✕. Presence of active documented systemic infection or recent systemic infection within the past three months
✕. Chemical and/or alcohol dependency or abuse
✕. Presence of low lying pelvic kidney(s). Pelvic and horse shoe kidneys are common in the Rokitansky syndrome, and occur with a frequency as high as 30-40%. These abnormalities are usually known to subjects as part of their Mullerian agenesis diagnosis. If the patient is unsure about the status of their kidneys, the performance of a renal ultrasound is considered standard of care. These patients need to be informed of any kidney abnormalities, as they are frequently associated with kidney stones or obstructive kidney disease.