RECRUITING

Testicular Tissue Cryopreservation for Fertility Preservation

Conditions

Cancer Autoimmune Disorders Spermatogonial stem cells Testis Fertility Infertility Oncofertility

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2010-01

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02972801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Rachel Neelley

CONTACT

412-641-7475

fertilitypreservation@upmc.edu

Principal Investigator

Kyle Orwig, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh/University of Pittsburgh Medical Center

Study Locations (Sites)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Kyle Orwig, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh/University of Pittsburgh Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-01

Study Completion Date2026-01

Study Record Updates

Study Start Date2010-01

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

Spermatogonial stem cells
Testis
Fertility
Infertility
Oncofertility

Additional Relevant MeSH Terms

Cancer
Autoimmune Disorders