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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 weeks
Treatment ~ Varies
Follow Up ~uterus transplantation to 5 years post uterus transplantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and uterus transplantation to 5 years post uterus transplantation for reporting.

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 more

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 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
2,327 Previous Clinical Trials
14,874,755 Total Patients Enrolled
Richard J Redett, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Azathioprine (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05646992 — Phase 2 & 3
Uterine Factor Infertility Research Study Groups: Uterus Transplant Recipient
Uterine Factor Infertility Clinical Trial 2023: Azathioprine Highlights & Side Effects. Trial Name: NCT05646992 — Phase 2 & 3
Azathioprine (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05646992 — Phase 2 & 3
~27 spots leftby Feb 2033