Testicular Tissue Cryopreservation in Children (NCT02872532) | Clinical Trial Compass
RecruitingNot Applicable
Testicular Tissue Cryopreservation in Children
United States200 participantsStarted 2016-08-16
Plain-language summary
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.
Who can participate
Age range0 Years – 17 Years
SexMALE
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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:
* 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 pa…
What they're measuring
1
Number of pregnancies and live births after transplantation of cryopreserved testicular tissue