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

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.

Study Overview

• Status: Withdrawn
• Conditions: Infertility; Cryopreservation
• Intervention / Treatment: Procedure: Testicular biopsy

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 39 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Status of frozen tissue	Subjects will be contacted to determine status of frozen tissue.	1 year post-procedure

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Serena Dovey, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 15-2047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO