School of Clinical Medicine, UNSW Sydney, Sydney, New South Wales, Australia.
The Royal Hospital for Women, Randwick, Sydney, Australia.
Aust N Z J Obstet Gynaecol. 2024 Aug;64(4):399-406. doi: 10.1111/ajo.13810. Epub 2024 Mar 28.
Uterus transplantation (UTx) is an emerging treatment option for women with uterine factor infertility (UFI) or the absence of a functional uterus. This is the study protocol for the first human UTx clinical trial in Australia.
This protocol outlines the approved training program used to plan, diagnose, screen, and treat patients who may be eligible for UTx using living and deceased donors. This multi-site clinical research study includes three tertiary hospital sites within New South Wales (NSW), Australia - Prince of Wales, Royal Hospital for Women and Westmead Hospitals. Our UTx protocol is based on that used by our collaborative partner, the inaugural UTx team in Gothenburg, Sweden. The Swedish UTx team provides ongoing preceptorship for the Australian UTx team. Ethics approval for six UTx procedures using living or deceased donors (Western Sydney Local Health District Human Research Ethics Committee: 2019/ETH138038) was granted in 2020.
Results from surgeries and live births will be published. Data will be prospectively entered into the registry of the International Society of Uterus Transplantation (ISUTx), a sub-section of The Transplantation Society (TTS).
ACTRN12622000917730.
A multidisciplinary research team has been formed between three tertiary hospitals in Sydney - The Royal Hospital for Women, Prince of Wales and Westmead Hospitals; and with the Swedish UTx, University of Gothenburg. The Swedish team pioneered animal and human UTx studies since 1998, including publishing the first live birth after UTx. (1) This Australian trial commenced in January 2023.
Uterus transplantation gives women with UFI the opportunity to be gestational and genetic mothers. It is a complex procedure for both the donor and recipient, with medical and surgical risks. An extensive multidisciplinary approach is required to optimise patient safety and graft outcomes. This protocol outlines our Australian UTx team strategy for screening, recruitment, surgical approach, and clinical management of UTx recipients and donors.
子宫移植（UTx）是治疗子宫因素不孕（UFI）或子宫功能缺失妇女的一种新兴治疗选择。这是澳大利亚首例人类 UTx 临床试验的研究方案。
本方案概述了经批准的培训计划，该计划用于规划、诊断、筛查和治疗可能有资格接受活体和已故供体 UTx 的患者。这项多中心临床研究包括澳大利亚新南威尔士州（NSW）的三个三级医院地点-王子皇后医院、皇家妇女医院和韦斯特米德医院。我们的 UTx 方案基于我们的合作伙伴瑞典哥德堡首例 UTx 团队的方案。瑞典 UTx 团队为澳大利亚 UTx 团队提供持续的指导。2020 年，六例使用活体或已故供体的 UTx 手术（西悉尼地方卫生区人类研究伦理委员会：2019/ETH138038）获得伦理批准。
手术和活产结果将予发表。数据将前瞻性地输入国际子宫移植协会（ISUTx）登记处，该协会是移植协会（TTS）的一个分部。
ACTRN12622000917730。
一个由悉尼三家三级医院（皇家妇女医院、王子皇后医院和韦斯特米德医院）和瑞典 UTx、哥德堡大学组成的多学科研究团队已经形成。瑞典团队自 1998 年以来率先开展了动物和人类 UTx 研究，包括发表首例 UTx 后的活产。（1）本项澳大利亚试验于 2023 年 1 月开始。
子宫移植使 UFI 妇女有机会成为妊娠和遗传母亲。这对供体和受体来说都是一个复杂的过程，存在医疗和手术风险。需要采取广泛的多学科方法来优化患者安全和移植物结局。本方案概述了我们澳大利亚 UTx 团队对 UTx 受者和供者的筛查、招募、手术方法和临床管理策略。
