Testicular Tissue Cryopreservation (TTC)

NCT06387498 | Recruiting DMC

• 1 other identifier: 20-2286
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Fertility preservation

Outcome Measures

Primary Outcomes (6)

• Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure

  Determine feasibility of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. Calculated by the percentage of eligible patients that elect to proceed with TTC.

  Up 3 months after prescribed gonadotoxic therapy

• Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve

  Determine feasibility of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. Calculated by the number of study participants whose tissue was successfully cryopreserved.

  Up to 48 hours after testicular tissue biopsy

• Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event

  The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with at least one of the following adverse events: 1) Bleeding, 2) Post-op infection, or 3) Long-term pain.

  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

  The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with bleeding.

  24 hours of the procedure

• Safety, as Assessed via the Number of Participants with At Least One Pre-specified

  The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with post-op infection.

  within 72 hours of the procedure

• Safety, as Assessed via the Number of Participants with At Least One Pre-specified

  The investigators will determine the safety of testicular tissue cryopreservation (TTC) in male patients receiving gonadotoxic therapies who desire fertility preservation. The number of participants with long-term pain.

  Assessed at 6 months

Secondary Outcomes (1)

• Acceptability, as Assessed via Annual Survey Regret Score

  Annually until the age of majority for the male participant

Study Arms (1)

Testicular Tissue Cryopreservation

EXPERIMENTAL

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

Procedure: Testicular tissue biopsy and cryopreservation

Interventions

Testicular tissue biopsy and cryopreservation PROCEDURE

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.

Testicular Tissue Cryopreservation

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Cryopreservation

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Study Officials

• Kristine Corkum, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristine Corkum, MD

CONTACT

(720) 777-6174; Kristine.Corkum@childrenscolorado.org

Jocelyn Phipers

CONTACT

303-724-7807; Jocelyn.Phipers@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: April 29, 2024
• Study Start: September 28, 2020
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)