Testicular Tissue Cryopreservation in Children

This study is looking at a procedure called testicular tissue cryopreservation, which involves removing and freezing testicular tissue. This is offered to boys aged 0 to 17 who have cancer or other conditions, or are facing treatments like surgery, chemotherapy, or radiation, that might cause them to lose their ability to have children later in life. The main goal is to see how many pregnancies and live births happen 10 to 20 years after this frozen tissue is transplanted. This procedure is currently considered experimental. The study aims to enroll 200 participants, but its current status is unclear.

Study design: This is an interventional study with a planned enrollment of 200 male participants aged 0 to 17 years.
What's involved: You would undergo a procedure to remove testicular tissue. After the procedure, you would have a follow-up visit at 1 week and then yearly.
Compensation: Not stated in the trial record.
Follow-up: Participants are followed up at 1 week post-surgery and then yearly thereafter, with the primary endpoint measured at 10-20 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Testicular Tissue Cryopreservation in Children

Recruiting

NAAges 0–17InterventionalTreatment

Mayo Clinic

~200 participants

Updated 2025-12-08 on ClinicalTrials.gov

What's tested:Testicular tissue 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

Number of pregnancies and live births after transplantation of cryopreserved testicular tissue

Measured over 10-20 years

Conditions

Cancer

Cancer-Related Condition

Infertility

NCT02872532

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Mayo Clinic in Rochester
Rochester, Minnesotastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Candace F. Granberg, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Asma Chattha, MBBS

[email protected]

507-538-0127

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

Be male 0-17 years of age

Meet at least one of the following four conditions:

Be 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. Risk categories based on treatment regimens are indicated below. Investigators will utilize three sources to calculate risk: 1. "Fertile Hope - Risks of Azoospermia" brochure that details typical agents and treatment regimens in each risk category, 2. The Summed Alkylating Agent dose score (Green et al., 2009) or 3. The Cyclophosphamide Equivalent Dose method (Green et al., 2014). Because of the complexity of many treatment regimens, patient risk categorization will be at the discretion of the investigators.

High Risk

\>= 80% risk of prolonged azoospermia, Fertile Hope Brochure

Summed alkylating agent dose score \>= 3

Cyclophosphamide equivalent dose \>= 7,500mg/m\^2

Intermediate risk (21-79% risk of prolonged azoospermia, Fertile Hope)

Low Risk ( =\< 20% risk of prolonged azoospermia, Fertile Hope)

Eligibility is limited to patients in the High risk category and/or intermediate risk after discussion with pediatric oncology, fertility preservation team, and the patient/family

Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles

Or, have a medical condition (genetic or autoimmune) that results in decline in fertility (e.g. Klinefelter syndrome)

Or, have a newly diagnosed or recurrent disease affecting fertility. Those who were not enrolled at the time of initial diagnosis (i.e. patients with recurrent disease) are eligible if they have not previous received therapy that is viewed as likely to result in complete and permanent loss of testicular function

Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options. Or have 1 testicle but limited potential for future fertility due to underlying condition, malignancy, prior surgery or previous torsion and no other fertility preservation methods are available except for testicular tissue cryopreservation

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 United States (U.S.) Department of Health and Human Services

Consent for serum screening tests for infectious diseases to be performed at the time of testicular tissue harvesting. The immediate testing will include but not be limited to testing for Hepatitis B, Hepatitis C, and human immunodeficiency virus (HIV)

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

Note: In cases of torsion of testicles or other medical conditions that result in impairment of testicular function, patients can be consented and included in the study, if during the testicular surgery the provider finds that the patient still has viable tissue that can be cryopreserved.

Exclusion

Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.

Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.

Previous recipients of gonadotoxic chemotherapy or radiation therapy thought to have resulted in impairment of testicular function.

What this trial measures

Number of pregnancies and live births after transplantation of cryopreserved testicular tissue10-20 years

Trialytics