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绝对子宫不孕症 (AUIF) 中的死亡子宫移植

2026年9月25日 更新者:Stefan G Tullius、Brigham and Women's Hospital

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.

研究概览

研究类型

介入性

注册 (估计的)

250

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • 招聘中
        • Brigham & Women's Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Evidence of AUFI diagnosed by BWH gynecologist
  • Ability to produce at least 6 euploid embryos for cryopreservation
  • BMI ≤ 30
  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:已故捐献者子宫移植

The recipient will be started on anti-rejection medications (as is routine for transplant recipients) prior to the OR. Standard of care anesthesia and line placement will take place. The recipient will be appropriately identified as an organ recipient and the donor organ identified per required transplant protocols already in place. The recipient team will then connect the vasculature and appropriate supporting structures for the uterus transplant. Once the organ has been re-perfused, the remainder of the operation will take place and the patient will be moved to the Intensive Care Unit and later to the transplant patient floor for standard monitoring.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Live Births Following Uterus Transplant
大体时间: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.

Within 5 years of transplant
Number of Surgically Successful Uterus Transplants
大体时间:Within 3 months of transplant

To achieve surgically successful uterus transplants.

Within 3 months of transplant

次要结果测量

结果测量
措施说明
大体时间
Financial impact of deceased donor uterus transplantation
大体时间:Through Study completion, up to 5 years post transplant

To analyze the overall impact of deceased donor uterus transplantation costs relative to established alternative procedures such as adoption and surrogacy.

Through Study completion, up to 5 years post transplant
Quality of life impact of deceased donor uterus transplantation
大体时间:Through study completion, up to 5 years post transplant

To analyze the overall impact of deceased donor uterus transplantation including changes in quality of life, relative to other established alternative procedures such as adoption and surrogacy.

Through study completion, up to 5 years post transplant

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Stefan G Tullius, MD、Brigham and Women's Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年1月1日

研究注册日期

首次提交

2019年5月2日

首先提交符合 QC 标准的

2019年7月18日

首次发布 (实际的)

2019年7月19日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2018P001782/PHS

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Data will be published or presented at scientific meetings or distributed upon request.

IPD 共享时间框架

For the duration of the study.

IPD 共享访问标准

Data will be published or presented at scientific meetings or distributed upon request.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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