NCT02972801 Testicular Tissue Cryopreservation for Fertility Preservation
| NCT ID | NCT02972801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2010-01-06 |
| Primary Completion | 2029-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2010-01-06 with a primary completion date of 2029-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Testicular tissue cryopreservation is an experimental procedure where a young boy's testicular tissue is retrieved and frozen. This technique is reserved for young male patients who are not yet producing mature sperm, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline.
Eligibility Criteria
Inclusion Criteria: * Be male at any age. * 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. * Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles. * Have newly diagnosed or recurrent disease. 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 all or part 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 * Consent for serum screening tests for infectious diseases \[HIV-1, HIV-2, Hepatitis B, Hepatitis C\], to be performed at the time of testicular tissue harvesting. * 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. * Participating in long term follow-up is a requirement of the protocol. 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.
Contact & Investigator
Kyle Orwig, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh/University of Pittsburgh Medical Center
Frequently Asked Questions
Who can join the NCT02972801 clinical trial?
This trial is open to male participants only, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02972801 currently recruiting?
Yes, NCT02972801 is actively recruiting participants. Contact the research team at fertilitypreservation@upmc.edu for enrollment information.
Where is the NCT02972801 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT02972801 clinical trial?
NCT02972801 is sponsored by University of Pittsburgh. The principal investigator is Kyle Orwig, PhD at University of Pittsburgh/University of Pittsburgh Medical Center. The trial plans to enroll 1,500 participants.
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