Reproductive, Obstetrical and Long-Term Health Outcome after Uterus Transplantation: Results of the First Clinical Trial

Abstract

Background: Uterus transplantation (UTx) is the first available treatment for absolute uterine factor infertility, caused by absence of the uterus or presence of a non-functional uterus. The proof-of-concept of this new fertility treatment was by the world´s first live birth after UTx in 2014. The present study represents the first report on outcome of a complete study cohort undergoing UTx and provides unique data on efficiency and long-term safety of this novel infertility treatment. Methods: We conducted a prospective clinical trial of nine live-donor UTx procedures at Sahlgrenska University Hospital, Gothenburg, Sweden. Seven grafts achieved long-term survival, thereby allowing pregnancy attempts. Hysterectomies were performed within seven years of UTx. The results of in vitro fertilisation, pregnancies, births, growth trajectory of children born, and the long-term medical and psychological health of patients are reported. Findings: Six women delivered nine healthy babies, with three women giving birth twice (cumulative birth rates of 86% in surgically successful transplants and 67% in performed transplants). The clinical pregnancy rate per embryo transfer (ET) was 32.6%. The livebirth rate per ET was 19.6%. Fetal growth and blood flow were normal in all pregnancies. Times of delivery (median in full pregnancy weeks+days (ranges)) by caesarean section and weight deviations were 35+3 (31+6 - 38+0) and -1% (-13% - +23%), respectively. Three women developed preeclampsia during pregnancy and four children acquired respiratory distress syndrome. All children were healthy and followed a normal growth trajectory. The long-term medical health of uterus donors and recipients was generally good. When UTx resulted in a birth, scores for anxiety, depression and relationship satisfaction were reassuring for both donors and recipients. Interpretations: The results of this first clinical UTx trial show that this is an effective infertility treatment for women with absolute uterine factor infertility, resulting in births of healthy children and associated with only minor psychological and medical long-term effects for live donors and graft recipients. Trial Registration: The prospective, observational study “Uterus transplantation from live donors” was registered as a clinical trial (NCT 01844362) Funding: Jan and Dan Olsson Foundation for Science, Knut and Alice Wallenberg Foundation, Swedish Research Council. Declaration of Interest: None of the authors have any conflict of interest. Ethical Approval: This study was approved by the Regional Ethics Committee of Gothenburg, Sweden (#88-12).