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Uterus Transplantation to Treat Infertility

NCT05646992 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-14

No results posted yet for this study

Summary

This research study will use uterus transplantation to treat uterine factor infertility, also known as the inability to bear children due to not having a uterus. The purpose of this study is to enable women seeking genetically-related children and the childbearing experience to experience pregnancy and birth a child. In this study, living donors will undergo surgery to give the donor's uterus to another woman. The woman who receives the transplant will take immunosuppression to keep the uterus and herself healthy. Because taking immunosuppressive medicine has side effects, uterus transplantation is intended to be temporary, lasting about 5 years.

The goals of the study are successful pregnancy and the birth of one, and possibly two, healthy babies per transplant patient. The uterus is to be removed and immunosuppression stopped following the birth of a child. Offspring are delivered by Caesarian section, at which time the transplant may also be removed.

Transplant candidates must have fertilized, frozen (cryopreserved) embryos at a Johns Hopkins facility before undergoing transplantation. Transplant candidates will be asked to identify candidates' potential uterus donor. Altruistic donors, or women who want to donate without knowing a potential recipient, may also participate. All potential donors will be screened to see if the donors are a good match for a recipient and are healthy enough to have the donation surgery.

Study Duration:

* Uterus Donors: Screening through about 12 months following the transplant operation.
* Uterus Recipients: Recipients may have the uterus for about 5 years. After the transplant is removed, the study team will ask for yearly follow-ups for another 5 years.
* Children born from transplanted uteruses: The study team asks to follow offspring yearly through age 21 years.

Conditions

  • Uterine Factor Infertility

Interventions

PROCEDURE

Uterine Allotransplantation

Temporary allogenic uterus transplantation from a living donor with the goal of achieving pregnancy and delivering viable baby.

DRUG

Tacrolimus

Used as daily immunosuppression. Started at 3mg twice daily (PO) on post-operative Day 1, adjusted to achieve serum trough concentrations of 8-10ng/ml.

DRUG

Imuran

Used as daily immunosuppresion. 100 mg for total body weight less than 75 kg and 150 mg for total body weight greater than or equal to 75 mgs

Sponsors & Collaborators

Principal Investigators

  • Richard J Redett, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2033-02-28
Completion
2043-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646992 on ClinicalTrials.gov