Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of Live Births Following Uterus Transplant
研究概览
简要总结
Our study will explore the feasibility of initiating a deceased donor uterine transplant program in addition to the existing living donor IRB at BWH.
Using the template established by teams around the world, we will identify emotionally and socially stable females of reproductive age with intact ovaries who are unable to gestate a child due to congenital or acquired uterine factor infertility. After careful screening, participants will undergo egg harvest, in vitro fertilization, and embryo cryopreservation using standard methods. Women who successfully complete the fertilization of at least six euploid embryos will be eligible to be placed on the waitlist for a deceased donor uterus transplant. After a successful transplant and a period of observation to ensure normal menstrual cycle and graft viability (anticipate six months), embryo implantation will be undertaken.
Following an embryo transfer, gestation will be carefully monitored by our high-risk pregnancy specialists. Medical research interventions include the surgical implantation of a uterus utilizing techniques by teams that have applied this approach successfully, close post-transplant follow up including immunosuppression therapy tailored to established standards during pregnancy minimizing fetal risks, and careful management of pregnancy. After childbearing is complete (at most two gestations), the donor uterus will be removed either during Cesarean or during an elective procedure. In addition, open ended interviews and surveys will be conducted to elicit ethical and psychosocial concerns arising from the experience of subjects and their families, health care providers, and the wider community. The investigator's intent is to monitor outcomes for transplant recipients as well as the live born infants for 30 days after removal of the transplanted uterus.
It is estimated that the time from screening to a potential live birth will be a minimum of 22 months, but likely between 24 - 36 months depending on organ availability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Evidence of AUFI diagnosed by BWH gynecologist
- •Ability to produce at least 6 euploid embryos for cryopreservation
- •GFR 60 or greater in any patient including those with a single kidney
- •PRA 20% or less
- •Deemed stable and capable of undergoing transplant by the transplant team to include psychiatry, social work, and transplant coordinator and study doctors to assure compliance with treatment
- •Evidence to be compliant with follow-up and immunosuppression
- •Partner willing to undergo psychological evaluation and receive immunizations as recommended
- •Stable home environment to support a child
排除标准
- •Active smoking, alcohol use or use of illicit drugs
- •Inability to follow a strict medication dosing schedule post-transplant and adhere to required follow-up appointments.
- •Any co-morbidities which would increase surgical risk, risk of pregnancy or the risk of taking anti-rejection medications as determined by the Maternal Fetal Specialist and Transplant Surgeon.
- •Active infection: HIV, Hepatitis B, Hepatitis C
- •Inadequate blood vessels to support the transplanted uterus.
- •Prior extensive abdominal or pelvic surgery
- •Presence of pelvic kidney
- •History of abnormal PAP
- •HPV related vulvar, vaginal or cervical dysplasia
- •Evidence of genital condylomata
- •History of PID
- •One or more living biological children
研究组 & 干预措施
Deceased Donor Uterus Transplant
干预措施: Uterine Transplant from Deceased Donor (Procedure)
结局指标
主要结局
Number of Live Births Following Uterus Transplant
时间窗: Within 5 years of transplant
To provide motherhood options for women with AUIF as an alternative to surrogacy or adoption, via gestating and giving birth via Cesarean section to a live infant.
Number of Surgically Successful Uterus Transplants
时间窗: Within 3 months of transplant
To achieve surgically successful uterus transplants.
次要结局
- Financial impact of deceased donor uterus transplantation(Through Study completion, up to 5 years post transplant)
- Quality of life impact of deceased donor uterus transplantation(Through study completion, up to 5 years post transplant)
研究者
Stefan G Tullius
Chief, Division of Transplant Surgery
Brigham and Women's Hospital