Freezing testicular tissue to help preserve fertility in young boys
Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens
NA · University of Pittsburgh · NCT02972801
This study is testing a method to freeze testicular tissue from young boys to help preserve their ability to have children later, especially if they need treatments that could affect their fertility.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Sex | Male |
| Sponsor | University of Pittsburgh (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT02972801 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are young males scheduled for gonadotoxic treatments or surgeries that may compromise their testicular function.
Not a fit: Patients who are not male or those who are not undergoing treatments that pose a risk to their fertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could offer hope for future fertility restoration in young boys facing treatments that threaten their reproductive capabilities.
How similar studies have performed: While this approach is novel for preadolescent boys, similar techniques in fertility preservation for adult males have shown success in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Autoimmune Disorders, Spermatogonial stem cells, Testis, Fertility, Infertility, Oncofertility