Uterine Transplantation for the Treatment of Uterine Factor Infertility

Launched by THE CLEVELAND CLINIC · Oct 8, 2015

Keywords

ClinConnect Summary

Uterine factor infertility (UFI) is one of the few irreversible causes of female infertility. Until recently, no medical or surgical options have been available for women with this diagnosis. UFI is defined by the lack of a functional uterus; this condition can either be congenital (e.g. Rokitansky syndrome, where a woman is born without an intact uterus) or acquired (e.g. resulting from hysterectomy or damage to the uterus from procedures or infections).

Uterine infertility affects 3-5% of the female population. It is estimated that there are at least 50,000 women of reproductive age with...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Must meet criteria for uterine factor infertility
• • 1. Prior hysterectomy
• • 2. Congenital absence or malformation of the uterus preventing pregnancy c, Infertility due to uterine damage from prior injury or infection
• • 2. 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)
• • 3. Must be willing to undergo a psychiatric and social work pre-transplant evaluation
• • 4. 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
• • 5. Must be willing and able to receive potent immunosuppressive medications and must be able to follow standard infection prophylaxis protocols
• • 6. Must be willing to receive standard vaccinations such as influenza, pneumococcus, human papillomavirus (HPV) and hepatitis B
• • 7. Must be willing and able to sign informed consent and follow all outlined procedures and recommendations in the protocol
• Exclusion Criteria:
• • 1. History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease
• • 2. Any medical diagnosis placing the subject at high risk of surgical complications based on the transplant team's review of medical history.
• • 3. Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
• • 4. History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years.
• • 5. 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.
• • 6. Presence of active documented systemic infection or recent systemic infection within the past three months
• • 7. Chemical and/or alcohol dependency or abuse
• • 8. 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.
• • 9. BMI greater than 30 kg/m2