Uterine Factor InfertilityPhase 2/3OPRTUNTINCT05646992
Uterus Transplantation to Treat Infertility
A Phase 2/3 study testing Uterine Allotransplantation, Tacrolimus and Imuran in people with Uterine Factor Infertility, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Factor Infertility
- What is being tested?
- Uterine Allotransplantation, Tacrolimus and Imuran
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 28 Feb 2043
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recipient Inclusion Criteria:
- Genotypic female of any race, color, or ethnicity.
- Uterine factor infertility.
- Aged 18-38 years at time of egg retrieval.
- Strong desire to undergo uterus transplant in order to become pregnant and give birth to a child.
- Embryo cryopreservation with embryos located at Johns Hopkins:
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- Has a minimum of 4-8 cryopreserved normal embryos following Preimplantation Genetic Screening (PGS-screening).
- OR o Is willing to undergo egg retrieval, in vitro fertilization, and PGS-screening to cryopreserve a minimum of 4-8 normal embryos.
- Willingness to undergo embryo implantation after uterus transplantation to achieve pregnancy.
- In the opinion of the study team, makes a reasonable effort to identify and refer her own potential uterus donor to the study team.
- Completes the protocol informed consent form.
- Non-smoker, defined by having never smoked or having quit >6 consecutive months prior to screening.
- No co-existing medical condition which, in the opinion of the study team, could affect the immunosuppression protocol, surgical procedure, or ability to be pregnant or bear a child. (See Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of uterus transplantation.)
- Negative serum pregnancy test.
- Blood type compatible with donor.
- Negative crossmatch with donor.
- Patient agrees to comply with the protocol and states a dedication to the treatment regime.
- Agrees to uterus explanation following birth of a child and or 5 years without successful pregnancy.
- Donor Inclusion Criteria:
- Genotypic female with an intact uterus.
- Medical history includes known successful pregnancy (e.g., gravid uterus).
- Aged 25 - 65 years.
- Consents to uterus donation and required pre-donation screening.
- For females of child-bearing potential: Negative serum pregnancy test.
- Blood type compatible with recipient.
- Negative crossmatch with recipient.
- Donor and Recipient Inclusion Criteria:
- USA citizen or equivalent.
- No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
- BMI ≤35
- o A higher BMI may be accepted at the discretion of the study team.
- Negative for HIV at transplant.
- Negative for malignancy for past 5 years.
Who cannot join
- Donor and Recipient Exclusion Criteria:
- Positive for any of the following conditions:
- Insulin-dependent diabetes mellitus.
- Untreated sepsis.
- HIV (active or seropositive).
- Active tuberculosis.
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- Active Hepatitis B infection.
- Active Hepatitis C infection.
- Viral encephalitis.
- Toxoplasmosis.
- Current/recent (within 3 months of donation/screening consent) IV drug abuse.
- Significant cardiac disease
- Significant vascular disease o
- Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigens (HLA) antibodies.
- Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.
- Mixed connective tissue diseases and collagen diseases that can result in poor wound healing after surgery.
- Severe neurologic deficits.
- Patients considered unsuitable per the consulted Psychiatric/Psychologic appraisal.
- A history of medical non-compliance.
- Donor Only Exclusion Criteria:
- Previous injury to the uterus including giving birth by Cesarean section.
- History of radiation therapy to the abdominal area.
- Other medical conditions, as determined by the study physicians, that would preclude donation.
- Recipient Only Exclusion Criteria:
- Conditions that, in the opinion of the study team, may expose the recipient to unacceptable risks under immunosuppressive treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Jane Littleton, AG-ACNP, FNP, 410-614-5551, jlittl38@jhmi.edu
Richard J. Redett, MD
About this study
Official title: OPRTUNTI: Offering Potential for Reproduction Through Transplantation of Uterus iN the Treatment of 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 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.
Read more
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.
Read the detailed description
This is a prospective clinical cohort study to establish temporary allogenic uterus transplantation as a feasible and effective reconstructive strategy for the treatment of uterine factor infertility.
Suitable candidates will proceed through as many as nine study stages:
- Stage 1: Telephone Screening Interview
- Stage 2: Blood Work Screening
- Stage 3: In Vitro Fertilization (IVF) \& Embryo Cryopreservation
- Stage 4: Full Screening
- Stage 5: Transplantation
- Stage 6: Embryo Transfer
- Stage 7: Pregnancy to Childbirth
- Stage 8: Uterus Explantation
- Stage 9: Longitudinal Follow-Up
Potential participants will first be screened by phone for general eligibility, motivations for transplantation, and probable identification of a living donor. Potential donors will be interviewed by an Independent Living Donor Advocate to determine eligibility. Suitable candidates and candidates' potential living donors will then undergo blood work screening to determine if it's an acceptable pairing for donation and transplantation. Next, if the recipient does not already have embryos banked at a Johns Hopkins Hospital facility, she will participate in IVF and embryo cryopreservation per standard of care protocols. After a sufficient number of fertilized embryos have been successfully stored, the participant and her living donor will undergo full study screening. Donor/recipient pairs deemed suitable for transplantation based on screening results will be scheduled for and undergo transplant surgery. Post-uterus donation, the donor will be followed according to post-hysterectomy surgery patient care protocols. Post transplantation, the recipient will continue under the care of the study team as a transplant patient as well as under the care of gynecologists, obstetricians, and maternal fetal medicine experts. Depending on the transplant recipient's post-operative course, embryo transfer may be attempted as early as 2 months post-transplant. Should the patient become pregnant, obstetrics will follow the participant's and her fetus' progress. Whether or not the recipient successfully carries a pregnancy or births a child, uterus explantation is an anticipated endpoint of this protocol. Patients will be counseled that participants may have the transplant to birth up to two offspring or for about five years, whichever comes first, after which removal of the uterus should be considered.
Study data on uterus transplant recipients will be collected for 5 years post-transplantation under this protocol, or for the entire time the participant has the graft, plus five years post-explantation. All attempts will be made to collect data on the offspring born as a result of this protocol through the offspring's 21st birthday.
- Conditions
- Uterine Factor Infertility
- Being tested
- Uterine Allotransplantation, Tacrolimus, Imuran
- Keywords
- Uterus/Transplantation, Uterus/Surgery, Vascularized Composite Allotransplantation (VCA), Immunosuppression, Mayer-Rokitansky-Küster-Hauser (MRKH), Allotransplantation, Humans, Female, Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine AllotransplantationProcedure or surgery
Temporary allogenic uterus transplantation from a living donor with the goal of achieving pregnancy and delivering viable baby.
TacrolimusDrug
Also called FK506
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.
ImuranDrug
Also called Azathioprine
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
| Study group | Role | What they receive |
|---|---|---|
| Uterus Transplant Recipient | Experimental | Uterus recipients, who are otherwise healthy, adult, genotypic females affected by uterine factor infertility, will undergo the surgically innovative uterus transplantation procedure combined with short-term use of conventional calcineurin inhibitor-based immunosuppression in to support a fetus to a viable delivery via Caesarian section. Receives: Procedure: Uterine Allotransplantation; Drug: Tacrolimus; Drug: Imuran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful delivery of viable baby
Successful implantation of fertilized embryo which is then carried to term with the baby delivered by Cesarean section.
Measured: Uterus transplantation to 5 years post uterus transplantation
Secondary outcomes (11)
Number of hazardous drinkers as assessed by Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
A brief alcohol screen that reliably identifies patients who are hazardous drinkers or have active alcohol use disorders
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Stress as assessed by the Brief Coping Orientation to Problems Experienced (COPE)
A 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Resilience as assessed by the Connor Davidson Resilience Scale (CD-RISC)-10
A unidimensional self-reported scale consisting of 10-items measuring resilience.
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Relationship quality as assessed by the Dyadic Adjustment Scale (DAS) [if having child with a partner]
A 32-item measure designed to assess the relationship quality of intact (married or cohabiting) couples.
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Drug use as assessed by the Drug Abuse Screening Test (DAST) 10 Drug Use Questionnaire
A 10-item self-report instrument which assesses drug use, not including alcohol or tobacco use, in the past 12 months.
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Depression as assessed by the Patient Health Questionnaire (PHQ-9)
A brief, self-administered questionnaire that assesses depression symptoms.
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Overall health status as assessed by the Medical Outcome Study Short Form-36 (SF-36)
A 36 item survey used to assess overall health status using 8 scaled scores for Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, and Mental health
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
PTSD as assessed by the Posttraumatic Stress Disorder Checklist (PCL-5 PTSD Checklist)
A 20-item self-report measure of the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) symptoms of Posttraumatic Stress Disorder PTSD
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Anxiety as assessed by the General Anxiety Disorder (GAD)-7
A 7-item self-report used to identify patients with anxiety.
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Positive outcomes as assessed by the Post-Traumatic Growth Inventory (PTGI)
A 21-item self-report measure used to assess positive outcomes after extremely stressful and potentially traumatic events.
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Life satisfaction as assessed by the Psychological Measures by Satisfaction with Life Scale (SWLS)
SWLS is a measure of life satisfaction. Uses scale to rate from 1-7, Where 1 indicates strongly disagree to 7 indicating strongly agree.
Measured: Pre-Transplantation Screening through 5 years post uterus explantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Mar 2023
- Primary completion28 Feb 2033 (estimated)
- Study completion28 Feb 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Factor InfertilityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard J Redett, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646992
- Sponsor's protocol ID
- IRB00166167
- Acronym
- OPRTUNTI
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPRTUNTI: Offering Potential for Reproduction Through Transplantation of Uterus iN the Treatment of Infertility
- ClinicalTrials.gov ID
- NCT05646992
- Acronym / sponsor ID
- OPRTUNTI / IRB00166167
- Conditions
- Uterine Factor Infertility
- Keywords
- Uterus/Transplantation, Uterus/Surgery, Vascularized Composite Allotransplantation (VCA), Immunosuppression, Mayer-Rokitansky-Küster-Hauser (MRKH), Allotransplantation, Humans, Female
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2033 (estimated)
- Study completion
- 28 Feb 2043 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective clinical cohort study to establish temporary allogenic uterus transplantation as a feasible and effective reconstructive strategy for the treatment of uterine factor infertility.
Suitable candidates will proceed through as many as nine study stages:
- Stage 1: Telephone Screening Interview
- Stage 2: Blood Work Screening
- Stage 3: In Vitro Fertilization (IVF) \& Embryo Cryopreservation
- Stage 4: Full Screening
- Stage 5: Transplantation
- Stage 6: Embryo Transfer
- Stage 7: Pregnancy to Childbirth
- Stage 8: Uterus Explantation
- Stage 9: Longitudinal Follow-Up
Potential participants will first be screened by phone for general eligibility, motivations for transplantation, and probable identification of a living donor. Potential donors will be interviewed by an Independent Living Donor Advocate to determine eligibility. Suitable candidates and candidates' potential living donors will then undergo blood work screening to determine if it's an acceptable pairing for donation and transplantation. Next, if the recipient does not already have embryos banked at a Johns Hopkins Hospital facility, she will participate in IVF and embryo cryopreservation per standard of care protocols. After a sufficient number of fertilized embryos have been successfully stored, the participant and her living donor will undergo full study screening. Donor/recipient pairs deemed suitable for transplantation based on screening results will be scheduled for and undergo transplant surgery. Post-uterus donation, the donor will be followed according to post-hysterectomy surgery patient care protocols. Post transplantation, the recipient will continue under the care of the study team as a transplant patient as well as under the care of gynecologists, obstetricians, and maternal fetal medicine experts. Depending on the transplant recipient's post-operative course, embryo transfer may be attempted as early as 2 months post-transplant. Should the patient become pregnant, obstetrics will follow the participant's and her fetus' progress. Whether or not the recipient successfully carries a pregnancy or births a child, uterus explantation is an anticipated endpoint of this protocol. Patients will be counseled that participants may have the transplant to birth up to two offspring or for about five years, whichever comes first, after which removal of the uterus should be considered.
Study data on uterus transplant recipients will be collected for 5 years post-transplantation under this protocol, or for the entire time the participant has the graft, plus five years post-explantation. All attempts will be made to collect data on the offspring born as a result of this protocol through the offspring's 21st birthday.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterus Transplant Recipient | Experimental | Procedure: Uterine Allotransplantation, Drug: Tacrolimus, Drug: ImuranUterus recipients, who are otherwise healthy, adult, genotypic females affected by uterine factor infertility, will undergo the surgically innovative uterus transplantation procedure combined with short-term use of conventional calcineurin inhibitor-based immunosuppression in to support a fetus to a viable delivery via Caesarian section. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (33 listed)
- Genotypic female of any race, color, or ethnicity.
- Uterine factor infertility.
- Aged 18-38 years at time of egg retrieval.
- Strong desire to undergo uterus transplant in order to become pregnant and give birth to a child.
- Embryo cryopreservation with embryos located at Johns Hopkins:
Key exclusion criteria (25 listed)
- Positive for any of the following conditions:
- Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigens (HLA) antibodies.
- Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.
- Mixed connective tissue diseases and collagen diseases that can result in poor wound healing after surgery.
- Severe neurologic deficits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine AllotransplantationTemporary allogenic uterus transplantation from a living donor with the goal of achieving pregnancy and delivering viable baby. | Procedure or surgery | Uterus Transplant Recipient |
| TacrolimusAlso: FK506Used 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 | Uterus Transplant Recipient |
| ImuranAlso: AzathioprineUsed 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 | Drug | Uterus Transplant Recipient |
Primary outcome
Successful delivery of viable baby
Time frame: Uterus transplantation to 5 years post uterus transplantation
Successful implantation of fertilized embryo which is then carried to term with the baby delivered by Cesarean section.
11 secondary outcomes
Number of hazardous drinkers as assessed by Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Stress as assessed by the Brief Coping Orientation to Problems Experienced (COPE)
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Resilience as assessed by the Connor Davidson Resilience Scale (CD-RISC)-10
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Relationship quality as assessed by the Dyadic Adjustment Scale (DAS) [if having child with a partner]
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Drug use as assessed by the Drug Abuse Screening Test (DAST) 10 Drug Use Questionnaire
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Depression as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Overall health status as assessed by the Medical Outcome Study Short Form-36 (SF-36)
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
PTSD as assessed by the Posttraumatic Stress Disorder Checklist (PCL-5 PTSD Checklist)
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Anxiety as assessed by the General Anxiety Disorder (GAD)-7
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Positive outcomes as assessed by the Post-Traumatic Growth Inventory (PTGI)
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Life satisfaction as assessed by the Psychological Measures by Satisfaction with Life Scale (SWLS)
Time frame: Pre-Transplantation Screening through 5 years post uterus explantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard J Redett, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Uterine Allotransplantation, Tacrolimus and Imuran in people with Uterine Factor Infertility, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Littleton, CRNP, MSN (410-955-6875, jlittl38@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful delivery of viable baby (time frame: Uterus transplantation to 5 years post uterus transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.