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. Identifier: NCT02972801
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : January 4, 2018
Children's 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
Information provided by (Responsible Party):
Kyle Orwig, University of Pittsburgh

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 Phase
Cancer Autoimmune Disorders Procedure: Testicular biopsy Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Testicular tissue biopsy
Testicular biopsy
Procedure: Testicular biopsy
Testicular biopsy is performed to obtain testicular tissue for cryopreservation

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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, RDR (Syphilis), CMV, HTLV-1, and HTLV-2], 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.

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 identifier (NCT number): NCT02972801

Contact: Hanna Pulaski, PhD 412-641-7475
Contact: Karen Peters 412-641-7475

United States, Pennsylvania
Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kyle E Orwig, PhD    412-641-2460   
Sponsors and Collaborators
University of Pittsburgh
Children's 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

Responsible Party: Kyle Orwig, Professor, University of Pittsburgh Identifier: NCT02972801     History of Changes
Other Study ID Numbers: PRO09120485
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
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.

Keywords provided by Kyle Orwig, University of Pittsburgh:
Spermatogonial stem cells

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases