Preserving testicular tissue in boys facing fertility risks
Testicular Tissue Cryopreservation for Fertility Preservation in Males Facing Fertility Threatening Diagnoses or Treatment Regimens
This study is testing a way to freeze testicular tissue for boys aged 0-17 who might lose their ability to have children due to medical treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 0 Years to 17 Years |
| Sex | Male |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation, Cyclophosphamide |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT02872532 on ClinicalTrials.gov |
What this trial studies
This protocol aims to provide testicular tissue cryopreservation for male pediatric patients aged 0-17 who are at risk of losing their fertility due to medical conditions or treatments such as surgery, chemotherapy, or radiation. The procedure is currently experimental and represents the only option for fertility preservation in pre-pubescent boys. Following the intervention, patients will be monitored one week post-surgery and annually thereafter to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates include male patients aged 0-17 who are scheduled for treatments that may lead to permanent loss of testicular function.
Not a fit: Patients who are not facing fertility-threatening medical conditions or treatments will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable boys at risk of infertility to preserve their reproductive potential for future use.
How similar studies have performed: While testicular tissue cryopreservation is considered experimental, similar approaches in fertility preservation have shown promise in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Candace F. Granberg, MD — Mayo Clinic in Rochester
- Study coordinator: Asma Chattha, MBBS
- Email: chattha.asma@mayo.edu
- Phone: 507-538-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.