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Testicular Tissue Cryopreservation for Fertility Preservation in Male Patients Facing Infertility-causing Diseases or Treatment Regimens

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ClinicalTrials.gov Identifier: NCT02687880
Recruitment Status : Not yet recruiting
First Posted : February 22, 2016
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Many chemotherapy and radiation-containing regimens for cancer or prior to bone marrow transplantation can cause sterility in children and young adults. In addition, some human disease conditions (e.g., Klinefelter's) are associated with infertility. Semen cryopreservation is available as a fertility-preserving option for post pubertal boys and adult men, but many do not take advantage of this option due in part to lack of information, illness, and/or time constraints relative to their treatment plan. Currently, no fertility-preserving options are available for prepubescent boys who are not yet producing sperm. The primary objective of the proposed study is to 1) Optimize techniques for cryopreserving testicular tissue, 2) Assess malignant contamination in testicular tissues and 3) develop methods to enrich spermatogonial stem cells and remove malignant contamination from testicular tissue. In addition, this study will process and cryopreserve tissue and/or cells for participating patients as a resource for future elective procedures to attempt fertility restoration.

Condition or disease Intervention/treatment
Infertility Cryopreservation Procedure: Testicular biopsy

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Testicular Tissue Cryopreservation for Fertility Preservation in Male Patients Facing Infertility-causing Diseases or Treatment Regimens
Estimated Study Start Date : December 30, 2018
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Group/Cohort Intervention/treatment
All Subjects
All subjects will undergo a surgical procedure (Testicular biopsy) to harvest their testicular tissue. In most cases, this will be done as part of their routine care but it is possible the subject may elect to have the procedure as part of a "research only" biopsy.
Procedure: Testicular biopsy
Subjects will undergo a surgical procedure to harvest their testicular tissue.




Primary Outcome Measures :
  1. Status of frozen tissue [ Time Frame: 1 year post-procedure ]
    Subjects will be contacted to determine status of frozen tissue.


Biospecimen Retention:   Samples With DNA
This study will provide a pool of research tissue that will be used to develop and test methods for manipulation and cryopreservation of testicular tissue. Progress in these investigations may open up a range of new fertility preservation techniques to patients that currently have no options. At the same time, a substantial portion of the patient's tissue will be cryopreserved and reserved for his own future use.


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Ages Eligible for Study:   31 Days to 39 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males 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.
Criteria

Inclusion Criteria:

  1. Male age 30 days (non-inclusive) to 39 years (inclusive).
  2. 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.
  3. Have a medical condition or malignancy that requires removal of all or part of one or both testicles.
  4. Have newly diagnosed or recurrent disease.

    a) 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.

  5. Have two testicles if undergoing elective removal of a testicle for fertility preservation only.

    b) Note: removal of both testicles will limit fertility preservation options.

  6. Fully executed approved informed consent and authorization permitting the release of personal health information.

    c) 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 Human Services.

  7. Consent for serum screening tests for infectious diseases [HIV-1, HIV-2, hepatitis B, hepatitis C, RDR (syphilis), CMV, HLTV-1, and HTLV-2], to be performed at the time of testicular tissue harvesting.
  8. Undergo a full history and physical examination.
  9. 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.

Exclusion Criteria:

  1. Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
  2. 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 ClinicalTrials.gov identifier (NCT number): NCT02687880


Contacts
Contact: Natalie Crump, MS 303-724-3378 natalie.crump@ucdenver.edu

Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Serena Dovey, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02687880     History of Changes
Other Study ID Numbers: 15-2047
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female