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

NCT02687880 | Withdrawn

• 1 other identifier: 15-2047
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility; Cryopreservation

Outcome Measures

Primary Outcomes (1)

• Status of frozen tissue

  Subjects will be contacted to determine status of frozen tissue.

  1 year post-procedure

Study Arms (1)

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

Interventions

Testicular biopsy PROCEDURE

Subjects will undergo a surgical procedure to harvest their testicular tissue.

All Subjects

Eligibility Criteria

• Age: 31 Days - 39 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Male age 30 days (non-inclusive) to 39 years (inclusive).
• 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.
• Have a medical condition or malignancy that requires removal of all or part of one or both testicles.
• 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.
• 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.
• 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.
• 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.
• Undergo a full history and physical examination.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

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.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Serena Dovey, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 22, 2016
• Study Start: December 30, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share