Recruiting

Fertility Preservation

Sponsor:

University of Pittsburgh

Code:

NCT02972801

Conditions

Cancer

Autoimmune Disorders

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Testicular biopsy

Study Details

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

Study ID

NCT02972801

Start date

Jan 6, 2010

Status verified date

Apr, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

Dec 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

1500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Testicular tissue biopsy

Testicular biopsy

Interventions

Testicular biopsy

Testicular biopsy is performed to obtain testicular tissue for cryopreservation

Primary outcome measure

  • Presence of spermatogonial stem cells in the testicular tissue as determined by histology. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Jen Anglin

412-641-7475fertilitypreservation@upmc.edu

Locations

Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jen Anglin

412-641-7475fertilitypreservation@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Spermatogonial stem cells
  • Testis
  • Fertility
  • Infertility
  • Oncofertility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-04-22.