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Uterine Transplant in Absolute Uterine Infertility (AUIF)

RecruitingPhase 2, Phase 3

Sponsor: Brigham and Women's Hospital

Conditions: Female Infertility

Interventions: Uterine Transplant

Countries: United States

This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of follow-up is planned.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 40 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Uterine Transplant Inclusion/Exclusion Criteria

RECIPIENT:Inclusion Criteria

* Age 18-40
* Clinical evidence of AUFI (Absolute Uterine Factor Infertility)
* Able to produce at least 6 normal embryos by IVF for future use
* Reasonable weight with BMI (Body Mass Index) less than 30.
* Normal kidney function
* Able to undergo transplant and be compliant with treatment
* Has stable partner and social supports
* Partner willing to undergo psychological evaluation and receive immunizations as recommended
* Stable home environment to support a child

Exclusion Criteria :

* Active smoking, alcohol use or use of illicit drugs
* Inability to comply with required treatment (taking pills, having biopsies, frequent appointments )
* Having a condition that would make pregnancy or taking anti rejection medicines too risky.
* Active infection: Human Immunodeficiency Virus (HIV) , Tuberculosis, Hepatitis B, Hepatitis C
* History of extensive abdominal or pelvic surgery
* History of abnormal Papanicolaou test (PAP smear) or genital warts
* History of pelvic inflammatory disease

DONOR:Inclusion criteria

* Age over 40 up to age 60
* Has completed having a family
* Previous pregnancies were carried to term (no miscarriages)
* Able to take a birth control pill containing estrogen
* Weight reasonable with BMI (Body Mass Index) of 30 or less
* Good social supports

Exclusion Criteria:

* Active smoking, alcohol use or use of illicit drugs
* Psychiatric illness
* Cervical or endometrial polyps (growths) or tumors in the uterus muscle
* History of more than 1 Caesarean section
* History of abnormal PAP smear or genital warts
* Internal scarring from extensive abdominal or pelvic surgery
* Hypertension, Coronary artery disease, Chronic Obstructive Lung disease (emphysema) and Diabetes
* Active cancer or incompletely treated cancer
* Active infection including Human Immunodeficiency Disease (HIV) , Tuberculosis, Hepatitis B or Hepatitis C
* Significant history of either blood clots or bleeding tendencies
* Evidence of coercion or exchange of money or goods for donating the organ

Locations (1)

Boston, Massachusetts, United States