Clinical trial NCT02687880: Testicular Tissue Cryopreservation for Fertility Preservation in Male Patients Facing Infertility-causing Diseases or Treatment Regimens
Official title: Testicular Tissue Cryopreservation for Fertility Preservation in Male Patients Facing Infertility-causing Diseases or Treatment Regimens
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility
Cryopreservation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 0
Sex: MALE
Minimum age (years): 31
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Status of frozen tissue
timeFrame: 1 year post-procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Serena Dovey, MD
role: PRINCIPAL_INVESTIGATOR
References: