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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
Infertility due to uterine damage from prior injury or infection
Must be between the ages of 21-45 and the embryos must have been produced between the age of 21-39 (age at the time the embryos are produced, not current age)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months after successful implantation of embryo
Awards & highlights
No Placebo-Only Group

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.
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.
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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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.
Select...
I have had a hysterectomy.
Select...
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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,050 Previous Clinical Trials
1,370,795 Total Patients Enrolled
2 Trials studying Infertility
40 Patients Enrolled for Infertility
Koji Hashimoto, MD, PhDPrincipal InvestigatorThe Cleveland Clinic
2 Previous Clinical Trials
48 Total Patients Enrolled
Cristiano Quintini, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
73 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
~1 spots leftby Oct 2025