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Testicular Tissue Freezing for Infertility (TTC Trial)

N/A
Recruiting
Led By Leslie Appiah, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function
Must not have
Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at a new way to preserve fertility in male patients who may become infertile due to their disease or treatment. They want to see if freezing a piece of testicular tissue is

Who is the study for?
This trial is for male patients of any age who may become infertile due to a medical condition or treatments that are harmful to reproductive cells. It's specifically aimed at those for whom freezing testicular tissue is the only option to preserve fertility.
What is being tested?
The study focuses on taking a small sample of testicular tissue and freezing it (cryopreservation) with the goal of preserving future fertility. The feasibility and acceptability of this procedure in patients at risk of infertility will be evaluated.
What are the potential side effects?
Potential side effects might include discomfort, bruising, or infection at the biopsy site where tissue is taken from the testicles. Long-term effects are uncertain since this is an experimental procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for treatment that may permanently affect my ability to produce sperm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a health condition that makes anesthesia and surgery riskier for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve
Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure
Safety, as Assessed via the Number of Participants with At Least One Pre-specified
+1 more
Secondary study objectives
Acceptability, as Assessed via Annual Survey Regret Score

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: Testicular Tissue CryopreservationExperimental Treatment1 Intervention
Enrolled participants will undergo a testicular tissue biopsy. The method and amount of tissue procurement will be at the discretion of the surgeon.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,803 Previous Clinical Trials
2,822,063 Total Patients Enrolled
12 Trials studying Infertility
30,328 Patients Enrolled for Infertility
Leslie Appiah, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
43,466 Total Patients Enrolled
1 Trials studying Infertility
26,704 Patients Enrolled for Infertility
~26 spots leftby Dec 2027
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