Testicular Tissue Cryopreservation for Fertility Preservation
A
Amanda J. Saraf, DO
Primary Investigator
Enrolling By Invitation
100 years and younger
Male
Phase
N/A
1000 participants needed
3 Locations
Brief description of study
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
This study will harvest testicular tissue from eligible patients, identified by their physician, who will undergo an infertility-causing treatment and for whom standard of care fertility preservation procedures are not available. Separate portions of the
harvested tissue and/or cells will be 1) designated for research and 2) cryo-preserved and for participating patients as a resource for future elective procedures to attempt restoration.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer, Autoimmune Disorders
-
Age: - 100 Years
-
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
01 Aug 2024.
Study ID: PRO09120485, PHO-UPMC-TTC, 13902
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
