Guidelines for standardized nomenclature and reporting in uterus transplantation: An opinion from the United States Uterus Transplant Consortium

Abstract

Uterus transplantation is a nascent but growing field. To support this growth, the United States Uterus Transplant Consortium proposes guidelines for nomenclature related to operative technique, vascular anatomy, and donor, recipient, and offspring outcomes. In terms of anatomy, the group recommends reporting donor arterial inflow and recipient anastomotic site delivering inflow to the graft and offers standardization of the names for the 4 veins originating from the uterus because of current inconsistency in this particular nomenclature. Seven progressive stages with milestones of success are defined for reporting on uterus transplantation outcomes: (1) technical, (2) menstruation, (3) embryo implantation, (4) pregnancy, (5) delivery, (6) graft removal, and (7) long-term follow-up. The 3 primary metrics for success are recipient survival (as reported for other organ transplant recipients), graft survival, and uterus transplant live birth rate (defined as live birth per transplanted recipient). A number of secondary outcomes should also be reported, most of which capture stage-specific milestones, as well as data on graft failure. Outcome metrics for living donors include patient survival, survival free of operative intervention, and data on complications and hospitalizations. Finally, we make specific recommendations on follow-up for offspring born from uterine grafts, which includes specialty surveillance as well as collection and reporting of routine pediatric outcomes. The goal of standardization in reporting is to create consistency and improve the quality of evidence available on the efficacy and value of the procedure.

Reply

“…The concept of success in uterus transplantation is defined in clear terms by the US Uterus Transplant Consortium and is broken down into 7 sequential milestones: technical success, menstruation, embryo implantation, pregnancy, delivery, graft removal, and long-term follow-up. 2 Our case meets 6 initial milestones of success, with ongoing assessment of the final milestone. An additional yet important determination of "success" is provided by the participants themselves, who have spoken out overwhelmingly in favor of the procedure despite the risks.…”

The path toward ectogenesis: looking beyond the technical challenges

“…One may draw here upon similar discussions from the context of UTx, where an international registry has been announced to determine the long-term safety of the procedure. Apart from questions about the duration of follow-up—the United States Uterus Transplant Consortium recommends a minimum of 5 years of follow-up of medical, cognitive, developmental, behavioral and social parameters—crucial challenges with respect to autonomy, consent, privacy and welfare of participants are being discussed [ 129 , 138 ]. Debates about how to manage trade-offs between the protection of personal information of participants and the interests of future beneficiaries of UTx may inform the future clinical introduction of AWT [ 129 ].…”

Preimplantation genetic testing for aneuploidy in uterus transplant patients

“…2 In the United States, there are currently three uterus transplantation clinical trials (Baylor Dallas, Cleveland Clinic, and Penn Medicine) that are actively recruiting patients, performing transplant procedures, and/or performing embryo transfers into transplant recipients. 5 Currently, all centers in the United States perform uterus transplantation through clinical research protocols (ClinicalTrials.gov identifiers NCT02656550, NCT03307356, and NCT02573415). These protocols have several common features, including a timeline in which patients undergo embryo banking [including ovarian stimulation, oocyte retrieval, and in vitro fertilization (IVF)] prior to being matched to a living or deceased uterus donor depending on journals.sagepub.com/home/reh Therapeutic Advances in Reproductive Health 15 the clinical trial.…”

“…2 In the United States, there are currently three uterus transplantation clinical trials (Baylor Dallas, Cleveland Clinic, and Penn Medicine) that are actively recruiting patients, performing transplant procedures, and/or performing embryo transfers into transplant recipients. 5…”