Testicular Tissue Cryopreservation for Fertility Preservation in Males Facing Fertility Threatening Diagnoses or Treatment Regimens
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Number of pregnancies and live births after transplantation of cryopreserved testicular tissue
Overview
Brief 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.
Detailed Description
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.
After completion of study intervention, patients are followed up at 1-week post-surgery and then yearly thereafter.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to 17 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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:
- •"Fertile Hope - Risks of Azoospermia" brochure that details typical agents and treatment regimens in each risk category,
- •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
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.
Outcomes
Primary Outcomes
Number of pregnancies and live births after transplantation of cryopreserved testicular tissue
Time Frame: 10-20 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Candace F. Granberg, M.D.
Principal Investigator
Mayo Clinic