Testicular Tissue Cryopreservation in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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Testicular tissue cryopreservation is currently considered experimental but offers the only opportunity for fertility preservation in pre-pubescent boys faced with a fertility threatening diagnosis or treatment plan.

Official Title
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Testicular Tissue Cryopreservation for Fertility Preservation in Males Facing Fertility Threatening Diagnoses or Treatment Regimens

Conditions
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Cancer

Intervention / Treatment
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* Procedure: Testicular tissue cryopreservation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (All inclusion criteria must be met.) Be male 0-17 years of age. Meet at least one of the following four conditions: a. 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, or 3. the Cyclophosphamide Equivalent Dose method. Because of the complexity of many treatment regimens, patient risk categorization will be at the discretion of the investigators. i. High Risk (1. ≥80% risk of prolonged azoospermia, Fertile Hope Brochure; 2. Summed alkylating agent dose score ≥3; 3. Cyclophosphamide equivalent dose ≥7,500mg/m2). ii. Intermediate Risk (21-79% risk of prolonged azoospermia, Fertile Hope). iii. Low Risk (≤20% risk of prolonged azoospermia, Fertile Hope). iv. Eligibility is limited to patients in the High Risk category. b. Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles. c. Or, have a medical condition (genetic or autoimmune) that results in decline in fertility (e.g. Klinefelter syndrome). d. 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 previously 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. 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. 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.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testicular tissue<br>Children faced with a fertility threatening diagnosis or treatment plan will be offered testicular tissue cryopreservation, particularly if pre-pubescent and without other options to preserve fertility. | Procedure: Testicular tissue cryopreservation<br>* Testicular tissue will be removed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pregnancies and live births after transplantation of cryopreserved testicular tissue |  | 10-20 years |