Medical Policy

This document addresses uterine transplantation, which has been proposed as a treatment of uterine (uterus) factor infertility. This procedure involves the transplantation of a healthy donor uterus obtained from living or recently deceased donor into an individual with a nonfunctioning or absent uterus. The scope of this document is limited to the transplant procedure only and does not address other related infertility treatments or obstetric services.

Note: Please see the following for additional information:

• CG-SURG-34 Diagnostic Hysteroscopy for Infertility

Note: For a high-level overview of this document, please see "Summary for Members and Families" below.

Investigational and Not Medically Necessary:

Uterine transplantation is considered investigational and not medically necessary for all uses, including but not limited to the treatment of uterine factor infertility due to nonfunctioning or absent uterus.

This document describes clinical studies and expert recommendations and explains whether certain medical services are appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Uterus transplantation is being studied as a possible treatment for uterine factor infertility, a condition where someone cannot become pregnant because they were born without a uterus or have one that does not work. This surgery involves placing a healthy uterus into someone who does not have one.

What the Studies Show

Research is still ongoing and more long-term studies are needed to understand if the surgery is safe and if it helps people become pregnant and give birth safely. Doctors also need to study the possible effects of the surgery and the strong medications used to prevent the body from rejecting the new uterus. These medications may affect both the pregnant person and the baby. Uterus transplants have shown early success in people with a rare condition called Mullerian agenesis, a congenital condition where the uterus and/or vagina fail to develop fully or are absent, but there is still no way to prevent the unborn baby from being exposed to the medications used to stop rejection of the transplant.

Is this clinically appropriate?

This treatment is not appropriate because it has not been studied enough to determine if it is safe or effective. Researchers have not yet developed a way to avoid exposing unborn babies to strong anti-rejection medications needed for the procedure, which may carry risks. Better studies with long follow-up times are needed to know if uterus transplant helps people have healthy pregnancies and healthy babies.

(Return to Description/Scope)

Summary

Uterine transplantation is an investigational procedure developed as an alternative to adoption or surrogacy for individuals with uterine factor infertility caused by an absent or nonfunctional uterus. The process involves IVF embryo creation, transplantation of a uterus from a living or deceased donor, and, after confirming viability (6-12 months post-surgery), embryo implantation leading to potential pregnancy and delivery via cesarean section. Early studies have demonstrated that uterus transplantation is feasible and can result in live births, though complications for both donors and recipients are common. Outcomes show live birth rates of 58-70% among successful grafts, with maternal risks such as gestational hypertension, preterm labor, and surgical complications, and neonatal risks like prematurity and low birth weight. The latest guidance from the American Society of Reproductive Medicine (ASRM, 2018) classifies uterus transplantation as experimental and recommends conducting it only under IRB-approved protocols with multidisciplinary teams. While it has shown promise for women with congenital conditions such as Mullerian agenesis, no current protocol eliminates fetal exposure to immunosuppressive drugs. Ongoing trials continue to assess long-term safety, feasibility, and potential future applications, including for transgender women, though robust data and standardized registries are still needed to evaluate its broader clinical utility.

Discussion

Uterine transplantation has been proposed as an alternative to adoption and surrogacy for individuals with uterine factor infertility  as a result of nonfunctioning or absent uterus. The process starts with creating an embryo using in vitro fertilization (IVF) in which the woman’s eggs are harvested, fertilized, and cryopreserved for transfer into the uterus following transplantation. A healthy uterus from a living or recently deceased donor is transplanted into the recipient. After approximately 6-12 months, if the transplanted organ has been deemed viable and functional, a single embryo IVF implantation procedure is conducted. If the procedure leads to a successful pregnancy, the pregnancy is treated as high-risk and the child is delivered via cesarean section at approximately 37 to 39 weeks. After one or two successful deliveries, the transplanted uterus is removed via hysterectomy to avoid the continued need for immunosuppressive medication (Brännström, 2014).

Johannesson and colleagues (2015) reported primary outcomes from a prospective case series of human uterine transplantation from live donors (NCT01844362). The study enrolled 9 participants presenting with absolute uterine factor infertility and viable uteri after undergoing live-donor uterine transplantation. The measured outcomes included menstruation, uterine artery blood flow, histology of cervical biopsy, and blood levels of tacrolimus. After the initial 6-month period, uterine grafts were removed in 2 participants, 1 related to persistent intrauterine infection and the other due to bilateral uterine vessel thrombosis. The authors reported initial 12-month outcomes on the 7 remaining participants, all of whom had normal menstrual patterns and uterine blood flow. A total of 9 rejection episodes (among 5 participants) were reported; all cases were subclinical and asymptomatic, and detected by cervical biopsy. All resolved by temporary therapy with glucocorticoids.

The 2018 ASRM position statement on uterus transplantation offers the following committee opinion:

• Uterus transplantation is an experimental procedure for the treatment of absolute uterus-factor infertility.
• Uterus transplantation should be performed within an IRB-approved research protocol.
• A uterus transplantation program requires a multidisciplinary team experienced with the technique prior to attempting transplantation in human subjects.
• The organ used during uterus transplantation can be from living or deceased donors; each approach has its own challenges and strengths.

Uterus transplantation is an experimental procedure that may allow women with absolute uterus-factor infertility to achieve a pregnancy.

Johannesson and colleagues (2022) reported initial outcomes data from the first 5 years of uterus transplantation, collected from three United States centers between 2016 and 2021. In this cohort study, 33 uterus transplants were performed, 21 (64%) from living donors and 12 (36%) from deceased donors, with a 74% (n=23 of 31 recipients) 1-year graft survival rate. A total of 58% of participants transplanted (19 of 33) achieved at least 1 live birth, 83% of recipients (19 of 23) with a viable graft at 1 year achieved at least 1 live birth post-transplant. All neonates were born live with median gestational age of 36 weeks and 6 days. The study was conducted in conjunction with a clinical trial, and the results cannot be generalized.

The World Professional Association for Transgender Health (WPATH) addresses uterus transplantation in the most recent version of the Standards Of Care For The Health Of Transgender And Gender Diverse People (version 8; Coleman, 2022). In summary, the authors conclude:

Statement 10.12
We suggest health care professionals caring for individuals with intersexuality and congenital infertility introduce them and their families, early and gradually, to the various alternative options of parenthood.

While uterus transplantation has had preliminary success in people with Mullerian agenesis, there is no protocol to date that avoids exposure of the developing fetus to the risk associated with the medication used to avoid transplant rejection.

In 2024, Testa and colleagues reported the outcomes of a study that explored whether uterus transplant is feasible, safe, and results in births of healthy infants. In this prospective case series, a total of 20 participants with uterine-factor infertility and at least 1 functioning ovary underwent uterine transplantation in a single tertiary care center between September 14, 2016, and August 23, 2019. The uterus from 2 deceased and 18 living donors was surgically placed in an orthotopic position with vascular anastomoses to the external iliac vessels. Participants underwent immunosuppressive therapy until the transplanted uterus was removed following 1 or 2 live births or post-graft failure. Of the 20 participants (ranging in age from 20-36 years, [median age 30 years]), 14 (70%) had a successful uterus allograft and gave birth to at least 1 live-born infant. Eleven of 20 participants had at least 1 complication. Maternal and/or obstetrical complications occurred in 50% of the successful pregnancies. The most common complications were gestational hypertension (2 [14%]), cervical insufficiency (2 [14%]), and preterm labor (2 [14%]). Among the 16 live-born infants, no congenital malformations were observed. The authors reported that based on the Clavien-Dindo grading system, 4 of 18 living donors had grade 3 complications resulting in lasting disability or organ resection. The median follow-up period was 5 years 3 months (range, 4 years 5 months to 7 years 4 months). The researchers concluded that uterine transplantation is technically feasible and has a high live birth rate post successful graft survival. However, adverse events are common, including medical and surgical risks affecting both the recipients and the donors.

Brännström and colleagues (2025) conducted a systematic review of 24 studies reporting 40 live births following uterine transplantation. All births occurred via cesarean section, nearly half of which were emergent. Of the 21 elective cesarean sections, 52.4% were performed before 37 weeks' gestation. Compared with general population data, mothers experienced higher rates of complications such as preeclampsia, gestational hypertension, premature rupture of membranes, placenta previa, gestational diabetes, placenta accreta spectrum, and intrahepatic cholestasis. Infants were also at increased risk, with high rates of prematurity, respiratory distress syndrome, low birth weight percentiles, and NICU admission. The authors concluded that pregnancies after uterine transplantation are high-risk, though delaying elective cesareans until after 37 weeks may decrease some complications. The authors emphasized the need for standardized registries to guide clinical care. Evidence quality was very low, as all included studies were case reports or case series.

There are recruiting and ongoing clinical trials studying uterine transplantation for treatment of uterine factor infertility due to a congenital or nonfunctional uterus. However, to date, results from these studies have not been published. Data from prospective, long-term studies are needed to determine the safety and clinical utility of the procedure, including potential long-term effects of transplantation and anti-rejection medications on both the mother and the baby. Other proposed uses that may further be explored in the future are the “views of transgender women on their reproductive aspiration, motivations, and desire to undergo uterus transplant should it eventually be proven feasible” (Jones, 2021).

While uterus transplantation has had preliminary success in people with Mullerian agenesis, there is no protocol to date that avoids exposure of the developing fetus to the risk associated with the medication used to avoid transplant rejection.

According to the Centers for Disease Control and Prevention (CDC), infertility affects nearly 6% of childbearing-aged women (15 to 49 years) in the United States (CDC, 2022). Nearly 1 in 5,000 females is born with mullerian agenesis (also referred to as mullerian aplasia, Mayer-Rokitansky-Küster-Hauser syndrome, or vaginal agenesis), a rare condition caused by embryologic underdevelopment of the mullerian duct, with resultant agenesis or atresia of the vagina, uterus, or both.

Uterus transplantation involves transplanting a uterus from a living or deceased donor into a recipient with no or underdeveloped uterus to restore reproductive ability and allow pregnancy. Unlike other organ transplants, it is not a lifesaving procedure and is intended to be temporary. The transplanted uterus is typically removed after a few years, once childbearing is complete or has been adequately attempted (Pereira, 2025).

Uterine transplantation is a complex, multi-stage surgery starting with uterus retrieval from a living or deceased donor. For living donors, robot-assisted laparoscopic hysterectomy is increasingly preferred because it lowers donor risks without affecting graft quality. Surgeons aim to preserve long vascular pedicles, including the uterine arteries and veins. After retrieval, the uterus is flushed, prepared, and checked for proper blood flow. The donor uterus is then placed in its normal anatomical position within the recipient (Pereira, 2025).

Since the first successful uterus transplant in 2011, more than 100 procedures have been performed worldwide using both living and deceased donors, resulting in an estimated 70-plus live births. In the United States alone, 48 uterus transplants and 33 live births had been reported as of May 1, 2024 (Testa, 2024).

Clavien-Dindo Grading System: A commonly used tool to classify surgical complications by the extent of the therapy necessary to resolve them.

Infertility: The Practice Committee of the ASRM published their Definition of Infertility in 2023. That definition is:

“Infertility” is a disease, condition, or status characterized by any of the following:

• The inability to achieve a successful pregnancy based on a patient’s medical, sexual, and reproductive history, age, physical findings, diagnostic testing, or any combination of those factors.
• The need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.
• In patients having regular, unprotected intercourse and without any known etiology for either partner suggestive of impaired reproductive ability, evaluation should be initiated at 12 months when the female partner is under 35 years of age and at 6 months when the female partner is 35 years of age or older (ASRM, 2023).

Institutional review board (IRB): An institutional review board is a group that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the subjects. The U.S. Food and Drug Administration (FDA) and the Office of Protection from Research Risks (part of the National Institutes of Health) set the guidelines and regulations governing human subject research and IRBs.

Uterine factor infertility: A condition where an individual woman cannot get pregnant because they either does not have a uterus or their uterus is no longer functioning correctly. This can be a result of a congenital condition or an acquired condition.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure codes, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Brännström M, Belfort MA, Ayoubi JM. Uterus transplantation worldwide: clinical activities and outcomes. Curr Opin Organ Transplant. 2021; 26(6):616-626.
2. Brännström M, Bokström H, Hagberg H, Carlsson Y. Maternal and perinatal outcomes of live births after uterus transplantation: a systematic review. Acta Obstet Gynecol Scand. 2025; 104(3):559-578.
3. Brännström M, Johannesson L, Dahm-Kähler P, et al. First clinical uterus transplantation trial: a six-month report. Fertil Steril. 2014; 101(5):1228-1236.
4. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240(2):205-213.
5. Järvholm S, Enskog A, Hammarling C, et al. Uterus transplantation: joys and frustrations of becoming a ‘complete’ woman - a qualitative study regarding self-image in the 5-year period after transplantation. Human Reproduction. 2020; 35(8):1855-1863.
6. Johannesson L, Järvholm S. Uterus transplantation: current progress and future prospects. Int J Womens Health. 2016; 8:43-51.
7. Johannesson L, Kvarnstrom N, Mölne J, et al. Uterus transplantation trial: 1-year outcome. Fertil Steril. 2015; 103(1):199-204.
8. Johannesson L, Richards E, Reddy V, et al. The first 5 years of uterus transplant in the US: a report from the United States Uterus Transplant Consortium. JAMA Surg. 2022; 157(9):790-797.
9. Jones BP, Rajamanoharan A, Vali S, et al. Perceptions and motivations for uterus transplant in transgender women. JAMA Network Open. 2021; 4(1):e2034561.
10. Testa G, Koon EC, Johannesson L, et al. Living donor uterus transplantation: a single center's observations and lessons learned from early setbacks to technical success. Am J Transplant. 2017; 17(11):2901-2910.
11. Testa G, McKenna GJ, Wall A, et al. Uterus transplant in women with absolute uterine-factor infertility. JAMA. 2024; 332(10):817-824.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Society for Reproductive Medicine (ASRM). American Society of Reproductive Medicine position statement on uterus transplantation: a committee opinion. Fertil Steril 2018; 110:605-610.
2. Coleman E, Radix AE, Bouman WP, et al. Standards of care for the health of transgender and gender diverse people, Version 8. Int J Transgend Health. 2022; 23(1):S1-S259.
3. Practice Committee of the American Society for Reproductive Medicine. Definition of infertility: a Committee Opinion (2023). Available at: https://www.asrm.org/globalassets/_asrm/practice-guidance/practice-guidelines/pdf/definition-of-infertility.pdf. Accessed on December 1, 2025.
4. Practice Committee of the American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2015; 103(6):e44-50.

1. American Society for Reproductive Medicine. Available at: https://www.asrm.org. Accessed on December 1, 2025.
2. Centers for Disease Control and Prevention. Infertility FAQs. Last reviewed May 15, 2024. Available at: https://www.cdc.gov/reproductive-health/infertility-faq/. Accessed on December 1, 2025.
3. United Network for Organ Sharing (UNOS). What organs can be transplanted? Available at: https://unos.org/transplant/. Accessed on December 1, 2025.

Uterine Transplantation

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