Testicular Tissue Cryopreservation (TTC)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06387498
Status
Recruiting
Apply to this trial

Conditions

  • Fertility Issues

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 28, 2020
Status verified
Sep 2025
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
Jocelyn Phipers, RN
[email protected]
303-724-7807
Kristine Corkum, MD
[email protected]
Kristine Corkum, MD (PRINCIPAL_INVESTIGATOR)

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University of Colorado· Aurora, CO

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