Freezing testicular tissue to help preserve fertility in young boys

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on testicular tissue cryopreservation, an experimental procedure aimed at preserving fertility for young male patients who are not yet producing mature sperm. The study involves harvesting testicular tissue from eligible boys who are scheduled to undergo treatments that may affect their fertility, such as chemotherapy or surgery. The harvested tissue will be frozen for potential future use when new reproductive therapies become available. This approach aims to provide a means of fertility preservation for preadolescent boys who currently lack established options.

Why it matters

Who can join: the full rules

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.

Where it's running

• Magee-Womens Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Kyle Orwig, PhD — University of Pittsburgh/University of Pittsburgh Medical Center
• Study coordinator: Jen Anglin
• Email: fertilitypreservation@upmc.edu
• Phone: 412-641-7475

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.