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Immunosuppressant
Uterus Transplant for Infertility (OPRTUNTI Trial)
Phase 2 & 3
Recruiting
Led By Richard J Redett, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up uterus transplantation to 5 years post uterus transplantation
Awards & highlights
No Placebo-Only Group
Summary
This trial will use uterus transplants to help women with uterine factor infertility achieve pregnancy & birth a child. Donors & recipients are carefully screened & followed for up to 21 years.
Who is the study for?
This trial is for women with uterine factor infertility who want to become pregnant and have a child. Candidates must be non-smokers, aged 18-38, with cryopreserved embryos at Johns Hopkins. Donors should have had successful pregnancies before, be aged 25-65, and meet health criteria including BMI ≤35 and no recent malignancies.
What is being tested?
The study tests uterus transplantation from living donors to recipients using immunosuppressive drugs (Imuran and Tacrolimus) to prevent organ rejection. The goal is for the recipient to achieve pregnancy and give birth via Caesarean section. Afterward, the transplanted uterus will be removed.
What are the potential side effects?
Potential side effects include those related to immunosuppression such as increased infection risk, possible organ inflammation due to drug reactions, surgical complications from both donation and transplant procedures, and the need for C-section delivery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ uterus transplantation to 5 years post uterus transplantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~uterus transplantation to 5 years post uterus transplantation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Successful delivery of viable baby
Secondary study objectives
Anxiety as assessed by the General Anxiety Disorder (GAD)-7
Depression as assessed by the Patient Health Questionnaire (PHQ-9)
Drug use as assessed by the Drug Abuse Screening Test (DAST) 10 Drug Use Questionnaire
+8 moreAwards & 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 Transplant RecipientExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
2019
Completed Phase 4
~5510
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,325 Previous Clinical Trials
14,874,840 Total Patients Enrolled
Richard J Redett, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 25 and 65 years old.I agree to have my uterus removed after childbirth or if I don't get pregnant within 5 years.I am a genetic female with an intact uterus.I strongly desire to have a uterus transplant to become pregnant and have a child.I am a female of any race or ethnicity.I am between 18 and 38 years old.I have never had a C-section, abdominal radiation, or other conditions that doctors say would prevent me from donating.My blood type matches with the donor's.My blood type matches the recipient's.I am willing to try getting pregnant through embryo implantation after a uterus transplant.I agree to follow the study's rules and am committed to the treatment plan.I have 4-8 normal embryos frozen at Johns Hopkins or am willing to undergo procedures to achieve this.I haven't had cancer for the past 5 years.I have never smoked or quit smoking more than 6 months ago.I am willing to try getting pregnant through embryo implantation after a uterus transplant.I strongly wish to have a uterus transplant to carry and give birth to a child.You don't have any issues with alcoholism or drug abuse.You are unable to get pregnant because of a problem with your uterus.
Research Study Groups:
This trial has the following groups:- Group 1: Uterus Transplant Recipient
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.
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