Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility

NCT02656550 | Active Not Recruiting DMC

• 1 other identifier: 015-158
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the treatment of absolute uterine infertility (AUI) due to congenital or surgical absence of a uterus or presence of a nonfunctioning uterus. The investigators will follow a model based on a Swedish study to enroll 20 women with functioning ovaries and successfully transplant the uterus from either a living or cadaveric donor, with the goal of live birth after transplantation.

Conditions

Absolute Uterine Infertility

Keywords

Uterine Transplant; AUI; Rokitansky Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of successful live births after uterine transplant and IVF.

  Full term birth by cesarean section.

  2 years after transplant

Study Arms (1)

Uterine Transplant

EXPERIMENTAL

Women will undergo uterine transplantation after IVF. Donor uterus will be from either a living donor or cadaveric.

Procedure: Uterine Transplant

Interventions

Uterine Transplant PROCEDURE

Transplant of a uterus from either a living donor or a deceased donor.,

Also known as: Thymoglobulin, Mycophenolate

Uterine Transplant

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with Absolute Uterine Infertility (AUI) and intact native ovaries.
• Women of childbearing age 20-35.
• Human papillomarvius negative or received vaccination for human papillomarvius virus (HPV). Subjects with a history of HPV in the past must show a negative history since and test negative at screening.
• A subject who is negative for Gonorrhea, Chlamydia and Syphilis.
• A subject with the history of Herpes (HSV-2) with no current symptoms. Subject may require preventative maintenance per study doctor discretion.
• Subjects have received counseling regarding infertility alternatives to uterine transplant such as adoption or surrogate pregnancy.
• Willing to undergo in-vitro fertilization and medically cleared for in-vitro fertilization.
• Evaluated by a fertility specialist and determined to have good ovarian reproductive potential and ability to carry fetus to term.
• Must have the ability to fund, either through third party coverage or through other their own personal financing, any expenses associated with assisted reproduction services provided to them.
• Meets physiological recipient criteria

You may not qualify if:

• Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test.
• Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or CellCept.
• Subject with existing hypertension, per investigator's discretion.
• Subject who has a history of solid organ or bone marrow transplant.
• Subject who has history of cancer in last five years.
• Subject with a body mass index \>30.
• Subject with an active infection.
• Subject who is seropositive for HIV, HBV, HCV
• Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator.
• Subject unwilling or unable to comply with study requirements.
• Subject unable to undergo in-vitro fertilization or not cleared for transplant.
• Subject who has smoked within the last 12 months.
• Subject who has alcohol or drug abuse within 12 months of screening.
• Subject with any pre-existing clinical or medical conditions that would pose the subject at an increased risk, as per the investigator's discretion.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (20)

• Brannstrom M. Uterus transplantation. Curr Opin Organ Transplant. 2015 Dec;20(6):621-8. doi: 10.1097/MOT.0000000000000246.

  PMID: 26536423 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

• Johannesson L, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Diaz-Garcia C, Olausson M, Brannstrom M. Uterus transplantation trial: 1-year outcome. Fertil Steril. 2015 Jan;103(1):199-204. doi: 10.1016/j.fertnstert.2014.09.024. Epub 2014 Oct 22.

  PMID: 25439846 BACKGROUND

• Brannstrom M, Johannesson L, Bokstrom H, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Milenkovic M, Ekberg J, Diaz-Garcia C, Gabel M, Hanafy A, Hagberg H, Olausson M, Nilsson L. Livebirth after uterus transplantation. Lancet. 2015 Feb 14;385(9968):607-616. doi: 10.1016/S0140-6736(14)61728-1. Epub 2014 Oct 6.

  PMID: 25301505 BACKGROUND

• Louden, K. (2009). Pregnancy After Transplantation: Improving Outcomes Through Counseling, Closed Management, and Research. Nephrology Times, 2(2), 11-13

  BACKGROUND

• Mann, W., Goff, B., Falk, S. et. al (2015). Radical Hysterectomy. UpToDate, 3303 (9).

  BACKGROUND

• Mukherjee, S. & Shapiro, R, et. al. (2011). Transplantation and Pregnancy. Kidney, 716, 1097.

  BACKGROUND

• Johannesson L, Wood-Trageser MA, Lesniak D, Punar M, Klingman L, Naziruddin B, Askar M, Demetris AJ, Testa G. Unique Lessons From the Natural Progression of Rejection in Human Uterine Allografts. Clin Transplant. 2024 Aug;38(8):e15434. doi: 10.1111/ctr.15434.

  PMID: 39166465 DERIVED

• Testa G, McKenna GJ, Wall A, Bayer J, Gregg AR, Warren AM, Lee SHS, Martinez E, Gupta A, Gunby R, Johannesson L. Uterus Transplant in Women With Absolute Uterine-Factor Infertility. JAMA. 2024 Sep 10;332(10):817-824. doi: 10.1001/jama.2024.11679.

  PMID: 39145955 DERIVED

• Johannesson L, Humphries LA, Porrett PM, Testa G, Anderson S, Walter JR, Rush M, Ferrando CA, O'Neill K, Richards EG. Classification and treatment of vaginal strictures at the donor-recipient anastomosis after uterus transplant. Fertil Steril. 2024 Sep;122(3):525-534. doi: 10.1016/j.fertnstert.2024.04.019. Epub 2024 Apr 16.

  PMID: 38636770 DERIVED

• Walter JR, Johannesson L, Falcone T, Putnam JM, Testa G, Richards EG, O'Neill KE. In vitro fertilization practice in patients with absolute uterine factor undergoing uterus transplant in the United States. Fertil Steril. 2024 Sep;122(3):397-405. doi: 10.1016/j.fertnstert.2024.04.017. Epub 2024 Apr 15.

  PMID: 38631504 DERIVED

• Johannesson L, Testa G, Petrillo N, Gregg AR. Unique risk factors for unplanned preterm delivery in the uterus transplant recipient. Hum Reprod. 2024 Jan 5;39(1):74-82. doi: 10.1093/humrep/dead240.

  PMID: 37994646 DERIVED

• Finotti M, Testa G, Koon EC, Johannesson L. Graft Hysterectomy After Uterus Transplantation With Robotic-assisted Techniques. Transplantation. 2023 Sep 1;107(9):e236-e237. doi: 10.1097/TP.0000000000004695. Epub 2023 Aug 21. No abstract available.

  PMID: 37606907 DERIVED

• Warren AM, McMinn K, Testa G, Wall A, Saracino G, Johannesson L. Motivations and Psychological Characteristics of Nondirected Uterus Donors From The Dallas UtErus Transplant Study. Prog Transplant. 2021 Dec;31(4):385-391. doi: 10.1177/15269248211046027. Epub 2021 Oct 29.

  PMID: 34713738 DERIVED

• York JR, Testa G, Gunby RT, Putman JM, McKenna GJ, Koon EC, Bayer J, Zhang L, Gregg AR, Johannesson L. Neonatal Outcomes after Uterus Transplantation: Dallas Uterus Transplant Study. Am J Perinatol. 2023 Jan;40(1):42-50. doi: 10.1055/s-0041-1727212. Epub 2021 Apr 20.

  PMID: 33878776 DERIVED

• Putman JM, Zhang L, Gregg AR, Testa G, Johannesson L. Clinical pregnancy rates and experience with in vitro fertilization after uterus transplantation: Dallas Uterus Transplant Study. Am J Obstet Gynecol. 2021 Aug;225(2):155.e1-155.e11. doi: 10.1016/j.ajog.2021.02.037. Epub 2021 Mar 12.

  PMID: 33716072 DERIVED

• Agarwal A, Johannesson L, Findeis SK, Punar M, Askar M, Ma TW, Pinto K, Demetris AJ, Testa G. Clinicopathological Analysis of Uterine Allografts Including Proposed Scoring of Ischemia Reperfusion Injury and T-cell-mediated Rejection-Dallas UtErus Transplant Study: A Pilot Study. Transplantation. 2022 Jan 1;106(1):167-177. doi: 10.1097/TP.0000000000003633.

  PMID: 33481553 DERIVED

• Johannesson L, Testa G, Putman JM, McKenna GJ, Koon EC, York JR, Bayer J, Zhang L, Rubeo ZS, Gunby RT, Gregg AR. Twelve Live Births After Uterus Transplantation in the Dallas UtErus Transplant Study. Obstet Gynecol. 2021 Feb 1;137(2):241-249. doi: 10.1097/AOG.0000000000004244.

  PMID: 33416285 DERIVED

• Johannesson L, Koon EC, Bayer J, McKenna GJ, Wall A, Fernandez H, Martinez EJ, Gupta A, Ruiz R, Onaca N, Testa G. Dallas UtErus Transplant Study: Early Outcomes and Complications of Robot-assisted Hysterectomy for Living Uterus Donors. Transplantation. 2021 Jan 1;105(1):225-230. doi: 10.1097/TP.0000000000003211.

  PMID: 32150040 DERIVED

• Warren AM, Testa G, Anthony T, McKenna GJ, Klintmalm GB, Wallis K, Koon EC, Gunby RT Jr, Johannesson L. Live nondirected uterus donors: Psychological characteristics and motivation for donation. Am J Transplant. 2018 May;18(5):1122-1128. doi: 10.1111/ajt.14670. Epub 2018 Feb 13.

  PMID: 29364592 DERIVED

MeSH Terms

Conditions

Mullerian aplasia

Interventions

thymoglobulin; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 15, 2016
• Study Start: November 11, 2015
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)