Uterine Transplant in Absolute Uterine Infertility (AUIF)

NCT02741102 | Recruiting Phase 2 DMC

• 1 other identifier: 2015P002552
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility

Keywords

Infertility; AUFI

Outcome Measures

Primary Outcomes (1)

• Number of successful live births following uterus transplant/embryo transfer

  Full term live birth by caesarian section after uterus transplant and IVF

  2 years after uterine transplant

Secondary Outcomes (5)

• Rate of complications during pregnancy in uterus transplant recipient

  9 months after pregnancy achieved by embryo transfer

• Rate of complications following uterine donation

  Up to 2 years post donation

• Impact of uterine donation on donor quality of life

  Up to 2 years post donation

• Cost comparison for uterine transplant vs. surrogacy vs adoption

  Up to 5 years after uterine transplant

• Impact of uterine transplant on quality of life

  Up to 5 years after uterine transplant

Study Arms (1)

Women with AUFI

EXPERIMENTAL

Women with AUFI must meet criteria for uterine transplant. In vitro fertilization to obtain 6 (screened) healthy embryos for cryo-preservation precedes uterine transplant from an appropriate donor The recipient will be required to take potent anti rejection medications including Thymoglobulin, Prednisone, Tacrolimus, Mycophenolate Mofetil (MMF) , later substituted with Azathioprine to avoid birth defects. One year later, up to 6 attempts using 1 screened embryo at a time will be tried to achieve pregnancy. During pregnancy, the high risk pregnancy and transplant teams will follow the recipient. The goal is a full term baby and delivery will be by Caesarian section. A second pregnancy may be attempted. Afterward, the uterus will be explanted.

Procedure: Uterine Transplant

Interventions

Uterine Transplant PROCEDURE

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.

Women with AUFI

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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
• Active smoking, alcohol use or use of illicit drugs
• Inability to comply with required treatment (taking pills, having biopsies, frequent appointments )
• Having a condition that would make pregnancy or taking anti rejection medicines too risky.
• Active infection: Human Immunodeficiency Virus (HIV) , Tuberculosis, Hepatitis B, Hepatitis C
• History of extensive abdominal or pelvic surgery
• History of abnormal Papanicolaou test (PAP smear) or genital warts

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (11)

• Armenti VT, Moritz MJ, Davison JM. Drug safety issues in pregnancy following transplantation and immunosuppression: effects and outcomes. Drug Saf. 1998 Sep;19(3):219-32. doi: 10.2165/00002018-199819030-00005.

  PMID: 9747668 BACKGROUND

• Brannstrom M, Johannesson L, Dahm-Kahler P, Enskog A, Molne J, Kvarnstrom N, Diaz-Garcia C, Hanafy A, Lundmark C, Marcickiewicz J, Gabel M, Groth K, Akouri R, Eklind S, Holgersson J, Tzakis A, Olausson M. First clinical uterus transplantation trial: a six-month report. Fertil Steril. 2014 May;101(5):1228-36. doi: 10.1016/j.fertnstert.2014.02.024. Epub 2014 Feb 27.

  PMID: 24582522 BACKGROUND

• Christensen, M, Kronberg, CJ, Knudsen UB: Pre-eclampsia and arterial stiffness - a 10 year follow-up of previous pre-eclamptic women. Pregnancy Hyprtens 2015; 5: 72-73.

  BACKGROUND

• Del Priore G, Saso S, Meslin EM, Tzakis A, Brannstrom M, Clarke A, Vianna R, Sawyer R, Smith JR. Uterine transplantation--a real possibility? The Indianapolis consensus. Hum Reprod. 2013 Feb;28(2):288-91. doi: 10.1093/humrep/des406. Epub 2012 Nov 30.

  PMID: 23202992 BACKGROUND

• Josephson MA, McKay DB. Women and transplantation: fertility, sexuality, pregnancy, contraception. Adv Chronic Kidney Dis. 2013 Sep;20(5):433-40. doi: 10.1053/j.ackd.2013.06.005.

  PMID: 23978550 BACKGROUND

• Lefkowitz A, Edwards M, Balayla J. The Montreal Criteria for the Ethical Feasibility of Uterine Transplantation. Transpl Int. 2012 Apr;25(4):439-47. doi: 10.1111/j.1432-2277.2012.01438.x. Epub 2012 Feb 23.

  PMID: 22356169 BACKGROUND

• Le Ray C, Coulomb A, Elefant E, Frydman R, Audibert F. Mycophenolate mofetil in pregnancy after renal transplantation: a case of major fetal malformations. Obstet Gynecol. 2004 May;103(5 Pt 2):1091-4. doi: 10.1097/01.AOG.0000124986.32858.ba.

  PMID: 15121619 BACKGROUND

• McKay DB, Josephson MA. Pregnancy in recipients of solid organs--effects on mother and child. N Engl J Med. 2006 Mar 23;354(12):1281-93. doi: 10.1056/NEJMra050431. No abstract available.

  PMID: 16554530 BACKGROUND

• Brannstrom M, Wranning CA, Altchek A. Experimental uterus transplantation. Hum Reprod Update. 2010 May-Jun;16(3):329-45. doi: 10.1093/humupd/dmp049. Epub 2009 Nov 7.

  PMID: 19897849 BACKGROUND

• Szekeres-Bartho J, Csernus V, Hadnagy J, Pacsa AS. Immunosuppressive effect of serum progesterone during pregnancy depends on the progesterone binding capacity of the lymphocytes. J Reprod Immunol. 1983 Mar;5(2):81-8. doi: 10.1016/0165-0378(83)90003-7.

  PMID: 6132996 BACKGROUND

• Balayla J, Dahdouh EM, Lefkowitz A; Montreal Criteria for the Ethical Feasibility of Uterine Transplantation Research Group. Livebirth after uterus transplantation. Lancet. 2015 Jun 13;385(9985):2351-2. doi: 10.1016/S0140-6736(15)61096-0. No abstract available.

  PMID: 26088636 RESULT

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Stefan G Tullius, M.D.

  Brigham and Womens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan G Tullius, M.D.

CONTACT

617-732-6866; stullius@partners.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief , Division of Transplant Surgery

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: April 18, 2016
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)