NCT03307356: UNTIL

The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial

Active, enrolled NA Last updated 5 August 2025

What this trial tests

NA trial testing Uterine Transplant in Mayer Rokitansky Kuster Hauser Syndrome in 10 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 January 2018

Primary endpoint
1 July 2029

1 July 2029

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	10 January 2018
Primary completion	1 July 2029
Estimated completion	1 July 2029
Sites	1 location across United States

Drugs / interventions tested

• Uterine Transplant

Conditions studied

• Mayer Rokitansky Kuster Hauser Syndrome — all drugs for Mayer Rokitansky Kuster Hauser Syndrome →
• Uterine Agenesis — all drugs for Uterine Agenesis →
• Infertility, Female, of Uterine Origin — all drugs for Infertility, Female, of Uterine Origin →
• Uterine Factor Infertility — all drugs for Uterine Factor Infertility →

Sponsor

University of Pennsylvania

Who can join

Adults 21 to 40, female only, with Mayer Rokitansky Kuster Hauser Syndrome or Uterine Agenesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Options for childbearing are limited for the thousands of women in the United States who suffer from absolute uterine factor infertility. Uterine transplantation is an emerging treatment that provides hope for these individuals.

In the Penn UNTIL trial, the investigators plan to perform uterus transplants on five women who will ultimately undergo embryo transfer, pregnancy, delivery, and then transplant hysterectomy.

This trial is accepting women in need of a transplant and also women who are interested in being a live donor.

For more information please visit: https://clinicalresearch.itmat.upenn.edu/clinicaltrial/4821/congenital-abnormalitiesfemale-infertility-penn-ut/

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Uterine transplantation and IVF for congenital or acquired uterine factor infertility: A systematic review of safety and efficacy outcomes in the first 52 recipients.
   Daolio J, Palomba S, Paganelli S, Falbo A, et al · · 2020 · cited 20× · PMID 32348371 · DOI 10.1371/journal.pone.0232323
2. Provider Knowledge and Support of Uterus Transplantation: Surveying Multidisciplinary Team Members.
   Riggan KA, Khan Z, Langstraat CL, Allyse MA. · · 2020 · cited 9× · PMID 32280925 · DOI 10.1016/j.mayocpiqo.2019.11.001
3. In vitro fertilization practice in patients with absolute uterine factor undergoing uterus transplant in the United States.
   Walter JR, Johannesson L, Falcone T, Putnam JM, et al · · 2024 · cited 6× · PMID 38631504 · DOI 10.1016/j.fertnstert.2024.04.017
4. Uterus Transplantation: Revisiting the Question of Deceased Donors versus Living Donors for Organ Procurement.
   Frisch EH, Falcone T, Flyckt RL, Tzakis AG, et al · · 2022 · cited 6× · PMID 35956131 · DOI 10.3390/jcm11154516
5. Preimplantation genetic testing for aneuploidy in uterus transplant patients.
   Chattopadhyay R, Richards E, Libby V, Flyckt R. · · 2021 · cited 4× · PMID 33959719 · DOI 10.1177/26334941211009848
6. Classification and treatment of vaginal strictures at the donor-recipient anastomosis after uterus transplant.
   Johannesson L, Humphries LA, Porrett PM, Testa G, et al · · 2024 · cited 1× · PMID 38636770 · DOI 10.1016/j.fertnstert.2024.04.019
7. Systematic Sampling of the Female Reproductive System for Molecular Characterization.
   Fisher SA, Grijalva M, Guo R, Johnston SA, et al · · 2023 · cited 1× · PMID 37584588 · DOI 10.1002/cpz1.848
8. Feasibility of Near-Infrared Spectroscopy for Monitoring Tissue Oxygenation During Uterus Transplantation and Hysterectomy.
   Applebaum J, Zhao D, Latif N, O'Neill K. · · 2025 · PMID 40725523 · DOI 10.3390/jcm14144832