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NCT05646992 · ClinicalTrials.gov registry record · Phase 2
Uterus Transplantation to Treat Infertility
A Phase 2 study of Uterine Factor Infertility, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05646992: Recruiting Phase 2 study of Uterine Factor Infertility, sponsored by Johns Hopkins University.
NCT05646992 is a Phase 2 study of Uterine Factor Infertility that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05646992, a Phase 2 study of Uterine Factor Infertility, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Successful implantation of fertilized embryo which is then carried to term with the baby delivered by Cesarean section.
Conditions Studied
Interventions
- DRUG Tacrolimus
- PROCEDURE Uterine Allotransplantation
- DRUG Imuran
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2043-02-28 |
| Phase | Phase 2 |
What NCT05646992 shows while recruiting
NCT05646992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Uterine Factor Infertility appearing as the primary indexed condition, and to 3 interventions - of which Tacrolimus is the first listed.
NCT05646992 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05646992 about?
NCT05646992 is a clinical study titled "Uterus Transplantation to Treat Infertility". 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 ...
What is the current status of trial NCT05646992?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-03-01. Estimated completion is 2043-02-28.
What conditions does trial NCT05646992 study?
This clinical trial studies the following conditions: Uterine Factor Infertility.
What interventions are being tested in trial NCT05646992?
The interventions under investigation include: Tacrolimus (DRUG), Uterine Allotransplantation (PROCEDURE), Imuran (DRUG).
Who is sponsoring clinical trial NCT05646992?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05646992 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05646992's enrollment target sits among peer trials
40 1362nd of 2000 higher than 543 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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