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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

Tracking Information
First Submitted Date October 12, 2016
First Posted Date November 23, 2016
Last Update Posted Date December 27, 2022
Study Start Date January 2010
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2016)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Testicular Tissue Cryopreservation for Fertility Preservation
Official Title Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
testicular tissue
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.
Condition
  • Cancer
  • Autoimmune Disorders
Intervention Procedure: Testicular biopsy
Testicular biopsy is performed to obtain testicular tissue for cryopreservation
Study Groups/Cohorts Testicular tissue biopsy
Testicular biopsy
Intervention: Procedure: Testicular biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 4, 2022)		 1000
Original Estimated Enrollment
 (submitted: November 21, 2016)		 250
Estimated Study Completion Date January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Rachel Neelley 412-641-7475 ext 1 fertilitypreservation@upmc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02972801
Other Study ID Numbers PRO09120485
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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
Supporting Materials: 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.
Current Responsible Party Kyle Orwig, University of Pittsburgh
Original Responsible Party Same as current
Current Study Sponsor University of Pittsburgh
Original Study Sponsor Same as current
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
Investigators
Principal Investigator: Kyle Orwig, PhD University of Pittsburgh/University of Pittsburgh Medical Center
PRS Account University of Pittsburgh
Verification Date December 2022