Clinical trial NCT06387498: Testicular Tissue Cryopreservation (TTC)
Official title: Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fertility Issues
Keywords: Fertility preservation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure
timeFrame: Up 3 months after prescribed gonadotoxic therapy
measure: Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve
timeFrame: Up to 48 hours after testicular tissue biopsy
measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event
timeFrame: Every six months throughout the life of the study (up to 7 years)
measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event
timeFrame: 24 hours of the procedure
measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified
timeFrame: within 72 hours of the procedure
measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified
timeFrame: Assessed at 6 months
Secondary outcomes:
measure: Acceptability, as Assessed via Annual Survey Regret Score
timeFrame: Annually until the age of majority for the male participant
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leslie Appiah, MD
role: PRINCIPAL_INVESTIGATOR
References: