The First 5 Years of Uterus Transplant in the US

Abstract

terus transplant is a treatment for women affected by absolute uterine-factor infertility (AUFI), previously considered untreatable. AUFI is a major cause of female infertility, reported to affect 1 in 500 women. 1,2 Primary care clinicians are typically the front line of care when AUFI is suspected or diagnosed. Given the lifeframing nature of the diagnosis, appropriate counseling is challenging. Many are told that family-building options are limited to use of a gestational carrier or adoption. 3 Uterus transplant uniquely restores reproductive ability and enables gestation and childbirth. 4 Increased data regarding outcomes following uterus transplant are essential to coun-sel individuals with AUFI to evaluate all available pathways to parenthood.The United States Uterus Transplant Consortium (USUTC)

Uterine Transplant—Progress, but Concerns Remain

“…Of 33 participants, 19 (58%) reached a live birth. Although not explicitly stated in the article, according to Figure 4, no birth reached full term (39 weeks). Recipients had an 83% chance for a live birth if the graft survived 1 year, corresponding to a recently published worldwide experience of 80% chance of live birth after uterine transplant …”

“…The first live birth following successful uterine transplant occurred in Sweden in 2014, marking the beginning of a new era for this life-generating transplant for those with absolute uterine factor infertility . Johannesson et al present 5-year data from the US Uterus Transplant Consortium. According to the registration file, the primary end points for trials NCT02656550 and NCT02573415 were live births and full-term births.…”

“…On the other hand, the claim that the data “demonstrate safety for the recipient, living donor, and child” is not accurate. From a methodological standpoint, to demonstrate safety, criteria would have to be determined a priori, sample size would need to be calculated, and the appropriate statistical analysis performed.…”

How Surgical Research Gave Birth to a New Clinical Surgical Field: A Viewpoint from the Dallas Uterus Transplant Study

“…The former included addition of routine intraoperative intravenous heparin prior to reperfusion to the recipient protocol, based on our experience with the eighth transplant, which remained ischemic after vascular clamp removal despite visually and Doppler-tested patent anastomoses. The importance of anticoagulation, as well as strategies such as intraoperative assessment of anastomotic site patency by Doppler velocimetry and postoperative ultrasound monitoring, to mitigate graft loss due to thrombosis is emphasized by early reports from the UTx registries/consortia, in which thrombosis was the leading cause of graft loss [41, 42]. Refinements to the DUETS protocol aimed at reducing risk to the recipients involved changes to the immunosuppression protocol that allowed ET as early as 3 months after induction therapy [55].…”

“…The first live birth following deceased donor UTx was reported in 2018 [40]. As of 2022, more than 80 UTx procedures have been performed in almost 20 centers in Europe, North America, Latin America, and Asia, resulting in more than 40 live births [41, 42]. In the decade that has followed the initiation of the first human clinical trial, there has been substantial evolution and innovation in the donor and recipient procedures and protocols, aimed at the dual goals of decreasing morbidity for living donors and recipients and increasing success rates of achieving live births.…”