Recruiting

Testicular Tissue Cryopreservation

Sponsor:

University of Colorado, Denver

Code:

NCT06387498

Conditions

Fertility Issues

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Testicular tissue biopsy and cryopreservation

Study Details

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.

Conditions

Fertility Issues

Study ID

NCT06387498

Start date

Sep 28, 2020

Status verified date

Sep, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Testicular Tissue Cryopreservation

Enrolled participants will undergo a testicular tissue biopsy. The method and amount of tissue procurement will be at the discretion of the surgeon.

Interventions

Testicular tissue biopsy and cryopreservation

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.

Primary outcome measure

  • Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure [ Time Frame: Up 3 months after prescribed gonadotoxic therapy ]
  • Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve [ Time Frame: Up to 48 hours after testicular tissue biopsy ]
  • Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event [ Time Frame: Every six months throughout the life of the study (up to 7 years) ]
  • Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event [ Time Frame: 24 hours of the procedure ]
  • Safety, as Assessed via the Number of Participants with At Least One Pre-specified [ Time Frame: within 72 hours of the procedure ]
  • Safety, as Assessed via the Number of Participants with At Least One Pre-specified [ Time Frame: Assessed at 6 months ]

Central Contacts and Locations

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Kristine Corkum, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Keywords

  • Fertility preservation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-09-16.