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Uterine Transplant in Absolute Uterine Infertility (AUIF)

Uterine Transplant in Absolute Uterine Infertility (AUIF)

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02741102
Enrollment
3
Registered
2016-04-18
Start date
2026-07-01
Completion date
2028-01-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility

Keywords

Infertility, AUFI

Brief summary

This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of follow-up is planned.

Detailed description

There are approximately 9.5 million women in the United States with Absolute Uterine Factor Infertility (AUFI).Congenital uterine infertility in women is linked to a malformed or absent mullerian system termed MRKH - Rokitansky's or Mayer-Rokitansky-Kuster-Hauser Syndrome). Additional causes of acquired uterine infertility include a hysterectomy subsequent to life-threatening hemorrhage during childbirth or as a consequence to a hysterectomy related to cervical cancer or for large symptomatic fibroids. Additional causes may include intrauterine adhesions subsequent to surgical abortion or infection. Uterine transplantation will provide a much needed medical option for many women in the U.S. and overseas who are unable to carry their own children based on uterine infertility. Centers outside of the US have initiated uterus transplant programs. Initial attempts were reported from Saudi Arabia. While the deceased donor transplant had been successful, successful pregnancies were not achieved. Another deceased donor transplant had been performed in Turkey with a uterus procured from a deceased donor. Although several IVF attempts had been performed, they had not resulted in live births. Uterus transplants from live donors have been successful. In October 2014, Swedish doctors treating a woman born without a uterus, announced the world's first live birth of a healthy baby boy after a live donor uterine transplantation. Since then, an additional three babies have been born in Sweden to mothers who received live donor uterus transplants. A fifth baby is at term and a 6th pregnancy has been reported. For this study, the investigators plan to screen 30 patients in order to enroll 10 patients, 5 recipients and their respective donors. Prospective recipients will undergo comprehensive medical and psychological evaluation. If deemed an appropriate candidate, In Vitro Fertilization would be started with the goal of obtaining 6 normal embryos for implantation. The uterus of a suitable live donor would then transplanted into the recipient. The recipient would need to take potent anti-rejection drugs and undergo regular assessments for rejection. After one year, embryo transfer to the transplanted uterus would be tried. Up to 6 cycles would be attempted hopefully resulting in pregnancy. If pregnancy results, the recipient would be followed by the high risk pregnancy team. Delivery will be by Caesarian Section. A woman may have up to 2 pregnancies with the transplanted uterus. The uterus is later removed so the recipient no longer has to take anti-rejection drugs.

Interventions

Treating Absolute Uterine Factor Infertility by Uterus Transplant. Potential recipients undergo IVF to obtain 6 embryos for cryopreservation followed by live donor uterine transplant. After 1 year, embryo transfer is done to achieve pregnancy. Delivery is by Caesarian section. The recipient may have up to 2 children by these methods and then the uterus is removed so that immunosuppression can be stopped.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

Uterine Transplant Inclusion/

Exclusion criteria

RECIPIENT:Inclusion Criteria * Age 18-40 * Clinical evidence of AUFI (Absolute Uterine Factor Infertility) * Able to produce at least 6 normal embryos by IVF for future use * Reasonable weight with BMI (Body Mass Index) less than 30. * Normal kidney function * Able to undergo transplant and be compliant with treatment * Has stable partner and social supports * Partner willing to undergo psychological evaluation and receive immunizations as recommended * Stable home environment to support a child

Design outcomes

Primary

MeasureTime frameDescription
Number of successful live births following uterus transplant/embryo transfer2 years after uterine transplantFull term live birth by caesarian section after uterus transplant and IVF

Secondary

MeasureTime frameDescription
Rate of complications during pregnancy in uterus transplant recipient9 months after pregnancy achieved by embryo transferClose monitoring for pre-eclampsia, hypertension, diabetes, and pre-term delivery. Monitoring for signs of rejection, should it occur, you would first be treated with steroids
Rate of complications following uterine donationUp to 2 years post donationMonitoring for excessive bleeding, infection and bladder dysfunction. Also monitoring blood clots in the legs.
Impact of uterine donation on donor quality of lifeUp to 2 years post donationMeasured by serial SF 36 QOL survey by psychiatrist at pre-donation and at follow-up appointments. The SF-36 evaluates general health perception, perceived change in health over time, physical functioning, role limitations due to physical or emotional health, and activity limitations. Emotional well-being will also be assessed using the Hospital Anxiety and Depression Scale (HADS), a validated questionnaire scored from 0 to 3 per item.
Cost comparison for uterine transplant vs. surrogacy vs adoptionUp to 5 years after uterine transplantAt the end of the study, investigators will calculate average cost of each modality, i.e. transplant vs surrogacy vs adoption to compare the three alternatives to infertility
Impact of uterine transplant on quality of lifeUp to 5 years after uterine transplantMeasured by serial SF 36 QOL survey by psychiatrist pre-transplant and at follow-up appointments..

Countries

United States

Contacts

CONTACTStefan G Tullius, M.D.
stullius@partners.org617-732-6866
PRINCIPAL_INVESTIGATORStefan G Tullius, M.D.

Brigham and Womens Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026