Jana Pittman, Mats Brännström, Neill Keily, Brigitte Gerstl, Elena Cavazzoni, Henry Pleass, Mianna Lotz, Natasha Rogers, Germaine Wong, Wayne Hsueh, Ashraf Hanafy, Jason A. Abbott, Rebecca Deans
{"title":"活体和死亡供体子宫移植治疗子宫因素性不孕妇女的研究方案。","authors":"Jana Pittman, Mats Brännström, Neill Keily, Brigitte Gerstl, Elena Cavazzoni, Henry Pleass, Mianna Lotz, Natasha Rogers, Germaine Wong, Wayne Hsueh, Ashraf Hanafy, Jason A. Abbott, Rebecca Deans","doi":"10.1111/ajo.13810","DOIUrl":null,"url":null,"abstract":"<div>\n \n <section>\n \n <h3> Aim</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Materials and Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>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). Trial Id: ACTRN12622000917730.</p>\n </section>\n \n <section>\n \n <h3> Discussion</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>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.</p>\n </section>\n </div>","PeriodicalId":55429,"journal":{"name":"Australian & New Zealand Journal of Obstetrics & Gynaecology","volume":"64 4","pages":"399-406"},"PeriodicalIF":1.4000,"publicationDate":"2024-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ajo.13810","citationCount":"0","resultStr":"{\"title\":\"A study protocol for live and deceased donor uterus transplantation as a treatment for women with uterine factor infertility\",\"authors\":\"Jana Pittman, Mats Brännström, Neill Keily, Brigitte Gerstl, Elena Cavazzoni, Henry Pleass, Mianna Lotz, Natasha Rogers, Germaine Wong, Wayne Hsueh, Ashraf Hanafy, Jason A. Abbott, Rebecca Deans\",\"doi\":\"10.1111/ajo.13810\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n <section>\\n \\n <h3> Aim</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Materials and Methods</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>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). Trial Id: ACTRN12622000917730.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Discussion</h3>\\n \\n <p>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. 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A study protocol for live and deceased donor uterus transplantation as a treatment for women with uterine factor infertility
Aim
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.
Materials and Methods
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
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). Trial Id: ACTRN12622000917730.
Discussion
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.
Conclusion
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.
期刊介绍：
The Australian and New Zealand Journal of Obstetrics and Gynaecology (ANZJOG) is an editorially independent publication owned by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the RANZCOG Research foundation. ANZJOG aims to provide a medium for the publication of original contributions to clinical practice and/or research in all fields of obstetrics and gynaecology and related disciplines. Articles are peer reviewed by clinicians or researchers expert in the field of the submitted work. From time to time the journal will also publish printed abstracts from the RANZCOG Annual Scientific Meeting and meetings of relevant special interest groups, where the accepted abstracts have undergone the journals peer review acceptance process.
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