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| Name | Class |
|---|---|
| Medical College of Wisconsin | OTHER |
| University of Chicago | OTHER |
| Helen DeVos Children's Hospital | OTHER |
| Seattle Children's Hospital |
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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.
Fertility status has an important impact on the post-treatment quality of life for cancer survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow transplantation). Semen cryopreservation is an established fertility preserving therapy, but is not accessible or appropriate for all men. Currently there are no therapies to preserve the future fertility of preadolescent boys. However, new reproductive therapies are under development and may one day offer "fertile hope" to those survivors that do not currently have access to fertility preserving therapies. Clinical management of fertility threatening diseases and treatments must have foresight of the gonadotoxic side effects and the potential for infertility. When no established fertility sparing options are available, it is reasonable to offer harvesting and cryopreservation of testicular tissue as a possible means of fertility preservation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testicular tissue biopsy | Experimental | Testicular biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testicular biopsy | Procedure | Testicular biopsy is performed to obtain testicular tissue for cryopreservation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of spermatogonial stem cells in the testicular tissue as determined by histology. | A segment of testicular specimen (~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jen Anglin | Contact | 412-641-7475 | 1 | fertilitypreservation@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kyle Orwig, PhD | University of Pittsburgh/University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
THe investigators will share IPD with the patient (and only the patient) within one year of enrollment. The investigators share study protocol and ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.
De-identified research data will be shared with collaborators via e-mail, and with the broader scientific community via publication and presentations at national/international meetings.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001327 | Autoimmune Diseases |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| OTHER |
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