Testicular Tissue Cryopreservation (TTC)
Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens.
University of Colorado, Denver
60 participants
Sep 28, 2020
INTERVENTIONAL
Conditions
Summary
The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility.
Eligibility
Inclusion Criteria13
- Male at any age.
- 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. Be in significant risk of infertility as defined by:
- Cyclophosphamide equivalent dose (CED) ≥4 g/m2
- Total body irradiation (TBI)
- Testicular radiation \>2.5 Gy
- Cisplatin 500 mg/m2
- Bone Marrow Transplant (BMT)
- Or have a medical condition or malignancy that requires removal of all or part of one or both testicles.
- Or 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 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 Human Services.
- Consent for serum tests for infectious diseases \[including Hepatitis B Surface Antigen, Hepatitis C Virus (HCV) Antibody, and Human Immunodeficiency Virus (HIV) antigen/antibody screen 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 American College of Cardiology/American Heart Association (ACC/AHA) Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.
Exclusion Criteria3
- Patients will be ineligible for participation in this study if they are:
- 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.
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Interventions
Surgical Procurement of Testicular Tissue: At early stages of technology development, simple orchiectomy (removal of one entire testicle) may give the best chance of preserving sufficient cells for effective therapy. However, incisional biopsy of up to 25% of tissue from one testis (wedge resection) will also be presented to the patient as an alternative option. The amount of testicular parenchyma removed will be at the discretion of the surgeon.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06387498