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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 belowSelect...
My infertility is due to previous damage to my uterus.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months after successful implantation of embryo
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months after successful implantation of embryo
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
1,052 Previous Clinical Trials
1,371,104 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of high blood pressure, diabetes, or major heart, liver, kidney, or brain disease.I quit smoking more than 3 months ago.You have a body mass index (BMI) higher than 30, which means you are overweight.Some women are born without a uterus, while others may have a uterus that is malformed or damaged, preventing pregnancyI had cervical cancer stage 1a or 1b and it's been over 3 years.I do not have HIV, tuberculosis, or active hepatitis B or C.I have not had a serious infection in the last 3 months.You have a specific type of infertility called uterine factor infertility.I know I have a low lying or abnormal kidney shape due to Rokitansky syndrome.My infertility is due to previous damage to my uterus.I am between 21-45 years old and my embryos were created when I was 21-39.I am willing to undergo surgeries and procedures related to pregnancy, including a possible hysterectomy.I am willing to get vaccines like flu, pneumonia, HPV, and hepatitis B.I am between 21-45 years old and my embryos were created when I was 21-39.You have a problem with using drugs or alcohol too much.I have had a hysterectomy.I am willing and able to take strong immune-weakening medications and follow infection prevention guidelines.You were born without a uterus or have a uterus that is not formed correctly, which makes it difficult for you to become pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Uterus Transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Infertility Patient Testimony for trial: Trial Name: NCT02573415 — N/A
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