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Testicular Tissue Cryopreservation for Fertility Preservation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02972801
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : December 27, 2022
Sponsor:
Collaborators:
Children's National Research Institute
Children's Hospital of Orange County
Children's Hospital Medical Center, Cincinnati
Ann & Robert H Lurie Children's Hospital of Chicago
Medical College of Wisconsin
Connecticut Children's Medical Center
Nationwide Children's Hospital
Washington University School of Medicine
Alfred I. duPont Hospital for Children
University of Miami
University of Chicago
Cook Children's Medical Center
Helen DeVos Children's Hospital
Seattle Children's Hospital
University of Texas
Oregon Health and Science University
Hackensack Meridian Health
Indiana University Health
Information provided by (Responsible Party):
Kyle Orwig, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment
Cancer Autoimmune Disorders Procedure: Testicular biopsy

Detailed Description:

Fertility status has an important impact on the post-treatment quality of life for cancer survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow transplantation). Semen cryopreservation is an established fertility preserving therapy, but is not accessible or appropriate for all men. Currently there are no therapies to preserve the future fertility of preadolescent boys. However, new reproductive therapies are under development and may one day offer "fertile hope" to those survivors that do not currently have access to fertility preserving therapies. Clinical management of fertility threatening diseases and treatments must have foresight of the gonadotoxic side effects and the potential for infertility. When no established fertility sparing options are available, it is reasonable to offer harvesting and cryopreservation of testicular tissue as a possible means of fertility preservation.

This study will harvest testicular tissue from eligible patients. Separate portions of the harvested tissue and/or cells will be 1) designated for research and 2) cryopreserved and maintained for participating patients as a resource for future elective procedures to attempt fertility restoration.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens
Study Start Date : January 2010
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Testicular tissue biopsy
Testicular biopsy
 Procedure: Testicular biopsy
Testicular biopsy is performed to obtain testicular tissue for cryopreservation


Outcome Measures
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Primary Outcome Measures :
  1. Presence of spermatogonial stem cells in the testicular tissue as determined by histology. [ Time Frame: 5 years ]
    A segment of testicular specimen (~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining


Biospecimen Retention:   Samples With DNA
testicular tissue

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients who will undergo an infertility-causing treatment and for whom standard of care fertility preservation procedures are not available will be identified by their physician.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972801


Contacts
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Contact: Rachel Neelley 412-641-7475 ext 1 fertilitypreservation@upmc.edu

Locations
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United States, Pennsylvania
Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Rachel Neelley    412-641-7475    fertilitypreservation@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Children's National Research Institute
Children's Hospital of Orange County
Children's Hospital Medical Center, Cincinnati
Ann & Robert H Lurie Children's Hospital of Chicago
Medical College of Wisconsin
Connecticut Children's Medical Center
Nationwide Children's Hospital
Washington University School of Medicine
Alfred I. duPont Hospital for Children
University of Miami
University of Chicago
Cook Children's Medical Center
Helen DeVos Children's Hospital
Seattle Children's Hospital
University of Texas
Oregon Health and Science University
Hackensack Meridian Health
Indiana University Health
Investigators
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Principal Investigator: Kyle Orwig, PhD University of Pittsburgh/University of Pittsburgh Medical Center
More Information
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Responsible Party: Kyle Orwig, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02972801    
Other Study ID Numbers: PRO09120485
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: December 27, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: We will share IPD with the patient (and only the patient) within one year of enrollment. We 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.
Keywords provided by Kyle Orwig, University of Pittsburgh:
Spermatogonial stem cells
Testis
Fertility
Infertility
Oncofertility
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases