Testicular Tissue Cryopreservation for Fertility Preservation
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|ClinicalTrials.gov Identifier: NCT02972801|
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : December 27, 2022
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|Condition or disease||Intervention/treatment|
|Cancer Autoimmune Disorders||Procedure: Testicular biopsy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2025|
Testicular tissue biopsy
Procedure: Testicular biopsy
Testicular biopsy is performed to obtain testicular tissue for cryopreservation
- Presence of spermatogonial stem cells in the testicular tissue as determined by histology. [ Time Frame: 5 years ]A segment of testicular specimen (~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972801
|Contact: Rachel Neelley||412-641-7475 ext email@example.com|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Rachel Neelley 412-641-7475 firstname.lastname@example.org|
|Principal Investigator:||Kyle Orwig, PhD||University of Pittsburgh/University of Pittsburgh Medical Center|
|Responsible Party:||Kyle Orwig, Professor, University of Pittsburgh|
|Other Study ID Numbers:||
|First Posted:||November 23, 2016 Key Record Dates|
|Last Update Posted:||December 27, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||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.|
Informed Consent Form (ICF)
|Time Frame:||We will share IPD with the patient (and only the patient) within one year of enrollment. We share study protocol and ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.|
|Access Criteria:||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.|
Spermatogonial stem cells
Immune System Diseases