Testicular Tissue Cryopreservation for Fertility Preservation
A
Amanda J. Saraf, DO
Primary Investigator
Enrolling By Invitation
Male
Phase
N/A
1000 participants needed
3 Locations
Overview
Testicular tissue cryopreservation is an experimental procedure where a young boy'sular 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 usedhe future to restore fertility when experimental techniques emerge from the research.
Description
Fertility status has an important impact on the post-treatment quality of life for cancerurvivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow). Semen cryopreservation is an established fertility preserving therapy, butble or appropriate for all men. Currently there are no therapies to preservehe 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 potentialy. When no established fertility sparing options are available, it isble to offer harvesting and cryopreservation of testicular tissue as a possible meansy 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 andd for participating patients as a resource for future elective procedures to attempty restoration.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Cancer, Autoimmune Disorders
-
Gender: Male
Inclusion Criteria:
- Be male at any age.
- Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for thevention of a medical condition or malignancy with risk of causingd complete loss of subsequent testicular function.
- Or, have a medical condition or malignancy that requires removal of all or part of oneboth testicles.
- Have newly diagnosed or recurrent disease. Those who were not enrolled at the time ofdiagnosis (i.e., patients with recurrent disease) are eligible if they haveviously received therapy that is viewed as likely to result in complete andular function.
- Have two testicles if undergoing elective removal of all or part of a testicle fory preservation only. Note: removal of both testicles will limit fertilityvation options.
- Sign an approved informed consent and authorization permitting the release of personalhealth information. The patient and/or the patient's legally authorized guardian mustknowledge in writing that consent for specimen collection has been obtained, indance 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(based on the most recent ACC/AHA Guideline for Perioperative Cardiovascularvaluation 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 givingully informed consent.
- Diagnosed with an underlying medical condition that significantly increases their riskhesia and surgery.
Updated on
15 May 2024.
Study ID: PRO09120485
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
