Testicular Tissue Cryopreservation for Fertility Preservation
NCT ID: NCT02972801
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2010-01-06
2026-01-01
Brief Summary
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Detailed Description
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This study will harvest testicular tissue from eligible patients. Separate portions of the harvested tissue and/or cells will be 1) designated for research and 2) cryopreserved and maintained for participating patients as a resource for future elective procedures to attempt fertility restoration.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Testicular tissue biopsy
Testicular biopsy
Testicular biopsy
Testicular biopsy is performed to obtain testicular tissue for cryopreservation
Interventions
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Testicular biopsy
Testicular biopsy is performed to obtain testicular tissue for cryopreservation
Eligibility Criteria
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Inclusion Criteria
* 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 an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
MALE
No
Sponsors
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Medical College of Wisconsin
OTHER
University of Chicago
OTHER
Helen DeVos Children's Hospital
OTHER
Seattle Children's Hospital
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Kyle Orwig
Professor
Principal Investigators
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Kyle Orwig, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh/University of Pittsburgh Medical Center
Locations
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Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Jen Anglin
Role: primary
Other Identifiers
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STUDY19020220
Identifier Type: -
Identifier Source: org_study_id