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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02687880
• Other study ID #: 15-2047
• Status: Withdrawn
• Start date: December 30, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: July 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 31 Days to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cryopreservation
• Infertility

Intervention

Procedure:
• Testicular biopsy
Subjects will undergo a surgical procedure to harvest their testicular tissue.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Status of frozen tissue	Subjects will be contacted to determine status of frozen tissue.	1 year post-procedure