Cryopreservation of testicular tissue for fertility preservation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on male patients who are at risk of infertility due to disease or gonadotoxic treatments. It aims to evaluate the feasibility and acceptability of testicular tissue cryopreservation as a method for preserving fertility. The study involves the procurement and processing of testicular tissue, followed by cryopreservation, while ensuring safety from malignant cell contamination. The goal is to provide a potential resource for future fertility restoration in patients who currently have no options for preserving their fertility.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Kristine Corkum, MD — University of Colorado, Denver
• Study coordinator: Kristine Corkum, MD
• Email: Kristine.Corkum@childrenscolorado.org
• Phone: (720) 777-6174

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.