NCT06387498 Testicular Tissue Cryopreservation (TTC)
| NCT ID | NCT06387498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Fertility Issues |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-09-28 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2020-09-28 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Male at any age. 2. 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) 3. Or have a medical condition or malignancy that requires removal of all or part of one or both testicles. 4. 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. 5. Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options. 6. 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. 7. 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. 8. 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 Criteria Patients will be ineligible for participation in this study if they are: 1. Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent. 2. Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
Contact & Investigator
Kristine Corkum, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06387498 clinical trial?
This trial is open to male participants only, studying Fertility Issues. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06387498 currently recruiting?
Yes, NCT06387498 is actively recruiting participants. Contact the research team at Kristine.Corkum@childrenscolorado.org for enrollment information.
Where is the NCT06387498 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06387498 clinical trial?
NCT06387498 is sponsored by University of Colorado, Denver. The principal investigator is Kristine Corkum, MD at University of Colorado, Denver. The trial plans to enroll 60 participants.