Could freezing testicular tissue save fertility for boys and men?
NCT ID NCT06387498
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This study looks at whether it's possible and safe to freeze testicular tissue for males of any age who face infertility due to medical treatments like chemotherapy or radiation. Researchers will collect a small sample of testicular tissue through a biopsy and freeze it for potential future use. The goal is to see how many eligible patients choose the procedure and how many have their tissue successfully preserved, while also tracking any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- testicular tissue biopsy and cryopreservation
- What this could lead to
- If successful, this could offer a way to preserve fertility for males who might otherwise become infertile due to medical treatments or conditions.
- What could go wrong
- This is an early feasibility study with only 60 participants. The procedure carries risks like bleeding, infection, or long-term pain, and it's not yet known if the frozen tissue can later restore fertility.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male at any age. 2. 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. Be in significant risk of infertility as defined by: * 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. Exclusion Criteria Patients will be ineligible for participation in this study if they are: 1. Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent. 2. Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado
RECRUITINGAurora, Colorado, 80045, United States
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