Pittman, Jana

Brännström, Mats

Keily, Neill

Gerstl, Brigitte

Cavazzoni, Elena

Pleass, Henry

Lotz, Mianna

Rogers, Natasha

Wong, Germaine

Hsueh, Wayne

Hanafy, Ashraf

Abbott, Jason A

Deans, Rebecca

2024-03-27

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.

School of Clinical Medicine, UNSW Sydney, Sydney, New South Wales, Australia.

The Royal Hospital for Women, Randwick, Sydney, Australia.

Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

The Royal Hospital for Women, Randwick, Sydney, Australia.

School of Clinical Medicine, UNSW Sydney, Sydney, New South Wales, Australia.

The Royal Hospital for Women, Randwick, Sydney, Australia.

NSW Organ and Tissue Donation Service, Sydney, New South Wales, Australia.

Westmead Hospital, Sydney, New South Wales, Australia.

Department of Philosophy, Macquarie University, Sydney, New South Wales, Australia.

Westmead Hospital, Sydney, New South Wales, Australia.

Westmead Hospital, Sydney, New South Wales, Australia.

The Royal Hospital for Women, Randwick, Sydney, Australia.

Department of Obstetrics and Gynaecology, The Royal Darwin Hospital, Darwin, Northern Territory, Australia.

School of Clinical Medicine, UNSW Sydney, Sydney, New South Wales, Australia.

The Royal Hospital for Women, Randwick, Sydney, Australia.

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 Mar 28. doi: 10.1111/ajo.13810. Online ahead of print.

1479-828X

https://pubmed.ncbi.nlm.nih.gov/38549233/?otool=iaurydwlib

https://hdl.handle.net/10137/13289

absolute uterine infertility

infertility

organ donation

uterus transplant

A study protocol for live and deceased donor uterus transplantation as a treatment for women with uterine factor infertility.

Journal Article

Publication