Testicular Tissue Cryopreservation for Fertility Preservation

NCT02972801 | Recruiting DMC

• 1 other identifier: STUDY19020220
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Testicular tissue cryopreservation is an experimental procedure where a young boy's testicular tissue is retrieved and frozen. This technique is reserved for young male patients who are not yet producing mature sperm, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline.

Conditions

Cancer; Autoimmune Disorders

Keywords

Spermatogonial stem cells; Testis; Fertility; Infertility; Oncofertility

Outcome Measures

Primary Outcomes (1)

• Presence of spermatogonial stem cells in the testicular tissue as determined by histology.

  A segment of testicular specimen (\~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining

  5 years

Study Arms (1)

Testicular tissue biopsy

EXPERIMENTAL

Testicular biopsy

Procedure: Testicular biopsy

Interventions

Testicular biopsy PROCEDURE

Testicular biopsy is performed to obtain testicular tissue for cryopreservation

Testicular tissue biopsy

Eligibility Criteria

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

You may qualify if:

• Be male at any age.
• Be 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.
• Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles.
• 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 all or part 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
• Consent for serum screening tests for infectious diseases \[HIV-1, HIV-2, Hepatitis B, Hepatitis C\], 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 ACC/AHA Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.
• Participating in long term follow-up is a requirement of the protocol.

You may not qualify if:

• 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 Pittsburgh: lead
• Medical College of Wisconsin: collaborator
• University of Chicago: collaborator
• Helen DeVos Children's Hospital: collaborator
• Seattle Children's Hospital: collaborator

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Autoimmune Diseases; Infertility

Condition Hierarchy (Ancestors)

Immune System Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Kyle Orwig, PhD

  University of Pittsburgh/University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jen Anglin

CONTACT

412-641-7475; fertilitypreservation@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: November 23, 2016
• Study Start: January 6, 2010
• Primary Completion (Estimated): December 28, 2029
• Study Completion (Estimated): May 31, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: THe investigators will share IPD with the patient (and only the patient) within one year of enrollment. The investigators share study protocol and ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.
• Access Criteria: De-identified research data will be shared with collaborators via e-mail, and with the broader scientific community via publication and presentations at national/international meetings.

Locations

US (1)