The costs per live birth after uterus transplantation: results of the Swedish live donor trial.

study questionWhat is the cost per live birth after live donor uterus transplantation in a Swedish clinical trial setting? SUMMARY ANSWER: The total cost per child, from a health care perspective, was calculated to be €124 894 and if only surgically successful transplants are considered, the total cost per live birth was €107 120. WHAT IS KNOWN ALREADY: Uterus transplantation has proved to be a feasible treatment for uterine factor infertility by accomplished live births, both after live donor and deceased donor transplantation procedures. Our previous study, the only existing cost analysis of uterus transplantation, found that the initial (up to 2 months after surgeries) societal costs of preoperative interventions, live donor uterus transplantation surgeries, and postoperative care were between €50 000 and €100 000 (mean €74 000) in Year 2020 values per uterus transplantation. That study also included costs of sick leave for both donors and recipients. STUDY DESIGN, SIZE, DURATION: This real-data health economic cost study is based on a prospective cohort study, which included nine live donor uterus transplantation procedures. Study duration included the time from the first pre-transplantation investigation until postoperative controls after graft removal. PARTICIPANTS/MATERIALS, SETTING,

methodsRecipients, live donors, and neonates of nine uterus transplantation procedures participated. The recipients and donors underwent pre-transplantation investigations with imaging, laboratory tests, and psychological/medical screening. In vitro fertilization with embryo cryopreservation was performed in advance of transplantation. Donor hysterectomy and transplantation were by laparotomy and the recipient received immunosuppression. Pregnancy attempts by ET started 1 year after transplantation and delivery was by caesarean section. Hysterectomy was performed either after birth of one or two children, after graft failure, or after multiple pregnancy failures. Nine transplantation procedures resulted in seven surgically successful (adequate blood flow and regular menstruations) grafts and six women delivered a total of nine children. MAIN RESULTS AND THE ROLE OF CHANCE: The total cost of preoperative investigations, live donor uterus transplantation, postoperative care, immunosuppression, IVF, follow-up, pregnancy care, delivery, and graft removal after completed childbirth(s) or failure to achieve live birth was calculated, based on inclusion of cost for six women, giving birth to a total of nine children, and three women, with no childbirth. Cost for live donors was also included in the analysis. The total cost per child was calculated to be €124 894. However, if only surgical successful transplants (seven out of nine transplants) are considered, the cost per live birth was €107 120. The cost for preoperative preparations with IVF, surgeries, and postoperative follow-up during the initial 2 months was around 53% of total costs. Smaller sub-costs were those for monitoring, ETs with additional IVF (14%), immunosuppression and other drugs from Month 3 until hysterectomy (13%), and pregnancy care with delivery and neonatal care (13%). LIMITATIONS, REASONS FOR CAUTION: Limitations are the restricted sample size, the experimental phase of the procedure and that the results only reflect the cost in one country (Sweden). WIDER IMPLICATIONS OF THE

findingsThe results provide the first information concerning the cost per child of the uterus transplantation intervention. In the future, the cost per child will most likely decrease due to predicted increase in the rate of surgical success, decreased surgical durations, decreased graft duration to achieve live birth(s), and increased rate of transplantations giving not only one, but two or three singletons. STUDY FUNDING/COMPETING INTEREST(S): Funding was received from the Jane and Dan Olsson Foundation for Science, the Knut and Alice Wallenberg Foundation, the Swedish Research Council, and an ALF grant from the Swedish state under an agreement between the government and the county councils. There are no conflicts of interest for any of the authors. TRIAL REGISTRATION NUMBER: NCT01844362.