Frozen hope: new study aims to help boys become fathers after cancer
NCT ID NCT02872532
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study offers boys aged 0-17 the chance to freeze testicular tissue before undergoing treatments like chemotherapy or radiation that could cause permanent infertility. The tissue is stored for potential future use to achieve pregnancy. Researchers will track whether transplanted tissue leads to successful pregnancies and live births.
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 cryopreservation (procedure)
- What this could lead to
- If successful, this could allow boys who lose fertility due to cancer treatment to father biological children later in life.
- What could go wrong
- This is an early-stage collection study; it's unknown if the frozen tissue will successfully restore fertility. The procedure itself carries surgical risks.
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
-
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
-
About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2016
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
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
-
0 to 17 years
- Sex
-
Male participants only
- Healthy volunteers
-
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: (All inclusion criteria must be met.) * 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 Criteria: (Any exclusion criteria will disqualify.) * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can colorectal surgery patients go home in two days?
- Can a personal navigator help young cancer patients through treatment?
- Can a smartwatch predict which cancer patients return to hospital?
- Two-Drug combo aims to stall advanced breast cancer
- The hidden handshake that decides whether an embryo implants
- Blood thinner flush could boost tumor biopsy success