Testicular Tissue Cryopreservation (TTC) (TTC)

Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens.

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.

Study Overview

• Status: Recruiting
• Conditions: Fertility Issues
• Intervention / Treatment: Procedure: Testicular tissue biopsy and cryopreservation

Detailed Description

For male patients who currently have no options for fertility preservation, this research proposal will enable optimization of testicular tissue procurement and processing, cryopreservation, and diagnosis/elimination of malignant cell contamination to ensure safety for future fertility-restoring treatments. While results from animal models and human organ donor experiments support the efficacy of testicular tissue/cell cryopreservation for fertility preservation and subsequent restoration, rigorous safety and efficacy data in human patients who will undergo infertility-causing therapies is lacking. However, the patients being recruited for this study currently have no options for future therapies aimed at fertility preservation without the preservation of their testicular tissue/cells prior to treatment. Thus, the current study will provide a potential resource for future fertility restoration.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jocelyn Phipers; Phone Number: 303-724-7807; Email: Jocelyn.Phipers@cuanschutz.edu
• Study Contact Backup: Name: Leslie Appiah, MD; Phone Number: 720-926-1970; Email: LESLIE.APPIAH@CUANSCHUTZ.EDU

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Jocelyn Phipers, RN; Phone Number: 303-724-7807; Email: jocelyn.phipers@cuanschutz.edu
      • Contact: Leslie Appiah, MD; Email: LESLIE.APPIAH@CUANSCHUTZ.EDU
      • Principal Investigator: Leslie Appiah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, HCV Antibody, and Human Immunodeficiency Virus (HIV) AG/AB 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability, as Assessed via Annual Survey Regret Score	The Decision Regret Scale measures distress or remorse after a health care decision. Possible scores range from 0-100, with higher scores indicating high regret.	Annually until the age of majority for the male participant

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Leslie Appiah, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Fertility preservation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 20-2286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No