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Testicular Tissue Cryopreservation Study

This study is for men of any age who are at high risk of becoming infertile due to a medical condition or treatment, such as chemotherapy. For some, freezing testicular tissue (testicular tissue cryopreservation) is the only option to preserve their fertility. The study aims to see if it's practical and acceptable to collect and freeze testicular tissue from these patients. This involves a surgical procedure to take a small piece of testicular tissue. Researchers will look at how many eligible patients have the procedure, how many successfully have their tissue frozen, and any safety concerns over seven years. This research could provide a way for these patients to have fertility restoration options in the future.

Study design
This is an interventional study planning to enroll 60 male participants. The study is focused on a procedure called testicular tissue biopsy and cryopreservation.
What's involved
You would undergo a surgical procedure to obtain testicular tissue. Safety will be monitored every six months throughout the study, which could last up to 7 years.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety for up to 7 years. Feasibility of the procedure is assessed up to 3 months after prescribed gonadotoxic therapy and up to 48 hours after the biopsy.

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NCT06387498

Testicular Tissue Cryopreservation (TTC)

Recruiting
NAAll AgesInterventionalPrevention
University of Colorado, Denver
~60 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:Testicular tissue biopsy and cryopreservation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure
Measured over Up 3 months after prescribed gonadotoxic therapy
+5 more outcomes measured

Conditions

Fertility Issues

Explore related trials

Fertility IssuesFertility Preservation

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Kristine Corkum, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Kristine Corkum, MD
[email protected]
(720) 777-6174
Email the study team

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Eligibility criteria

Inclusion

Cyclophosphamide equivalent dose (CED) ≥4 g/m2
Total body irradiation (TBI)
Testicular radiation \>2.5 Gy
Cisplatin 500 mg/m2
Bone Marrow Transplant (BMT) 3. Or have a medical condition or malignancy that requires removal of all or part of one or both testicles. 4. Or have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function. 5. Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options. 6. Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services. 7. Consent for serum tests for infectious diseases \[including Hepatitis B Surface Antigen, Hepatitis C Virus (HCV) Antibody, and Human Immunodeficiency Virus (HIV) antigen/antibody screen to be performed at the time of testicular tissue harvesting. 8. Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent American College of Cardiology/American Heart Association (ACC/AHA) Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.

What this trial measures

  • Feasibility, as Assessed via the Percentage of Eligible Patients who do a ProcedureUp 3 months after prescribed gonadotoxic therapy

    Determine feasibility of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. Calculated by the percentage of eligible patients that elect to proceed with TTC.

  • Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to CryopreserveUp to 48 hours after testicular tissue biopsy

    Determine feasibility of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. Calculated by the number of study participants whose tissue was successfully cryopreserved.

  • Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse EventEvery six months throughout the life of the study (up to 7 years)

    The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with at least one of the following adverse events: 1) Bleeding, 2) Post-op infection, or 3) Long-term pain.

  • Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event24 hours of the procedure

    The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with bleeding.

  • Safety, as Assessed via the Number of Participants with At Least One Pre-specifiedwithin 72 hours of the procedure

    The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with post-op infection.

  • Safety, as Assessed via the Number of Participants with At Least One Pre-specifiedAssessed at 6 months

    The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with long-term pain.