Testicular Tissue Cryopreservation in Children
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004891
NCT ID: NCT02872532
Sponsor Protocol Number: 15-004891
About this study
This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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:
- “Fertile Hope – Risks of Azoospermia” brochure that details typical agents and treatment regimens in each risk category 1);
- The Summed Alkylating Agent dose score (Green et al., 2009); or
- 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/m2.
- 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.
- 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 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 HIV.
- Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent ACC/AHA Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.
- Eligibility will be recorded using a written checklist based on the criteria listed above and will be verified by an investigator prior to initiating experimental interventions.
Exclusion Criteria:
- 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.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available