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Procedure

Uterus Transplant for Infertility

N/A
Waitlist Available
Led By Koji Hashimoto, MD, PhD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be willing and able to receive potent immunosuppressive medications and must be able to follow standard infection prophylaxis protocols
Infertility due to uterine damage from prior injury or infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months after successful implantation of embryo
Awards & highlights

Study Summary

This trial aims to enroll 10 subjects who will have a uterus transplant from a deceased donor. 50-100 patients will be screened to identify these 10 subjects. There are 7 phases to the study, including embryo transfer and pregnancy/delivery.

Who is the study for?
This trial is for women aged 21-45 with uterine factor infertility, who've had a hysterectomy or have congenital absence/malformation of the uterus. Participants must be willing to undergo extensive medical procedures including IVF, major surgery, and high-risk pregnancy. They should agree to psychiatric evaluation and take immunosuppressive drugs post-transplant.Check my eligibility
What is being tested?
The study tests the feasibility of deceased donor uterine transplantation in women unable to carry a pregnancy due to lack of a functional uterus. It involves screening candidates, IVF treatment before transplant, monitoring through potential pregnancy after embryo transfer, and follow-up care.See study design
What are the potential side effects?
Potential side effects include complications from general anesthesia, surgical risks from gynecologic operations and cesarean delivery, high-risk pregnancy issues, reactions to immunosuppressive medications required post-transplantation (increased infection risk), and possible need for another hysterectomy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to take strong immune-weakening medications and follow infection prevention guidelines.
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My infertility is due to previous damage to my uterus.
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I am between 21-45 years old and my embryos were created when I was 21-39.
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I am willing to undergo surgeries and procedures related to pregnancy, including a possible hysterectomy.
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I am willing to get vaccines like flu, pneumonia, HPV, and hepatitis B.
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I am between 21-45 years old and my embryos were created when I was 21-39.
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I have had my uterus removed.
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I am willing to undergo major surgeries and procedures related to pregnancy and fertility.
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I have had a hysterectomy.
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I am willing and able to take strong immune-weakening medications and follow infection prevention guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months after successful implantation of embryo
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months after successful implantation of embryo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Transplantation
Secondary outcome measures
rate of neonatal complications
rate of pregnancy complications after IVF and uterus transplant

Trial Design

1Treatment groups
Experimental Treatment
Group I: Uterus TransplantationExperimental Treatment1 Intervention
Women will undergo deceased donor uterine transplantation after IVF.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,365,065 Total Patients Enrolled
2 Trials studying Infertility
40 Patients Enrolled for Infertility
Koji Hashimoto, MD, PhDPrincipal InvestigatorThe Cleveland Clinic
2 Previous Clinical Trials
45 Total Patients Enrolled
Cristiano Quintini, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Uterus Transplant (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02573415 — N/A
Infertility Research Study Groups: Uterus Transplantation
Infertility Clinical Trial 2023: Uterus Transplant Highlights & Side Effects. Trial Name: NCT02573415 — N/A
Uterus Transplant (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02573415 — N/A
Infertility Patient Testimony for trial: Trial Name: NCT02573415 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrolling for this experiment still an option?

"According to clinicaltrials.gov, this experiment is not presently seeking participants. Initially posted on October 1st 2015 and last updated September 20th 2022, the investigation is inactive at present; however, there are 245 other trials actively recruiting patients right now."

Answered by AI

Does this research encompass participants aged 75 and above?

"The requirements for this trial mandate that the applicant to be between 18 and 45 years old. Alternatively, 14 studies are available to people younger than eighteen and 34 trials offer options for those above 65."

Answered by AI

Am I eligible to sign up for this experiment?

"This research requires 10 individuals suffering from primary uterine infertility in the 21-45 age range, with embryos produced between 21-39. The necessary prerequisites include undergoing psychological and social work evaluations, general anaesthesia, IVF procedures, a high risk pregnancy and cesarean delivery followed by hysterectomy to remove the graft. Additionally, participants must be capable of taking immunosuppressive medications and following infection prevention protocols; those who have had prior hysterectomies or congenital birth defects preventing conception are excluded."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Ohio
How old are they?
18 - 65
What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I've tried to find other studys I had to have a surgery right away and now I can't have kids with my husband I would love to be able to have a chance and a family with me and my husband.
PatientReceived 2+ prior treatments
~1 spots leftby Oct 2025