Memphis, Tennessee 38119


Purpose:

PURPOSE: Primary objective: To assess the feasibility and outcomes of male fertility preservation by sperm freezing prior to starting treatment requiring alkylating agents and/or total body irradiation. Secondary objective: To assess pre- and post-treatment sperm production and hormonal status by measurement of serum anti-mullerian hormone (AMH), inhibin-B, follicle stimulating hormone (FSH), luteinizing hormone (LH), testosterone, and androstendione.


Study summary:

RATIONALE: In June 2006, the American Society of Clinical Oncology published a series of recommendations on fertility preservation for patients with cancer, concluding that "To preserve the full range of options, fertility preservation, approaches should be considered as early as possible during treatment planning". These guidelines reflect the greater attention that has been given in recent years to the fertility complications that can occur as a result of cancer treatment (eg, chemotherapies and radiation). Different cancer treatments such as cytotoxic therapy can lead to azoospermia and sterility for an unknown period. Whether the type of cancer significantly affects semen quality or not is under debate. In some studies, semen quality of cancer patients did not differ significantly from those without, but other studies have indicated a significant decrease in sperm quality in some malignancies such as testicular cancer and Hodgkin. Fertility and reproductive function are the principal concerns in 80% of successfully treated men with cancer. Although cancer survivors can become parents by adoption or gamete donation, most would prefer to have biologic parenthood and biologically related children. POPULATION: Adult and post-pubertal males, 13 years of age or older, presenting to our clinic because diagnosed with cancer, who wish to preserve their future fertility. If minors, parents or guardians have to give consent to the procedure while the boys give their assent. DESIGN: This is a prospective observational cohort study. PROCEDURES: Subject Recruitment and Screening Subjects will be recruited by referral from the Memphis area cancer centers and physicians whose patients express the desire to have pre-treatment sperm cryopreservation. Minors will be recruited by referral from the St. Jude Children's Research Hospital (SJCRH) and Methodist-Le Bonheur physicians. These subjects will undergo an informed consent process in accordance with University of Tennessee Health Science Center and SJCRH Institutional Review Board. If the five years of storage are up before subjects are ready to claim it, it will be their responsibility to keep the account open by paying a fee of about $300.00 per any additional year in storage. If they withdraw from the study before the five years are up, they will be free to claim the sperm from storage or to leave it there until the five years are up. Afterwards, they will be responsible for the annual fees. Long term Semen Freezing : After freezing, sperm samples will be sent to FairFax Cryobank in Austin, Texas for long-term storage. A storage agreement plan has been pre-arranged with FairFax and University of Tennessee Medical Group. Follow-up clinical information will be collected only when patients return for fertility treatment, if coming to our facility. No follow-up evaluation will be performed if the patients decide to have their specimens shipped to their new hometown or fertility clinic. However, patients will be asked to contact the investigators regarding their serum/tissue sample use and fertility outcomes. If no contact in this regard is made, patients will be re-contacted by the investigators once every year, if at that time they are 18 years old, or older, and if the five-year storage has expired.


Criteria:

Inclusion Criteria: - male, aged 13 years or older, - diagnosed with cancer, but not yet undergoing therapy - willing to participate in this clinical trial - signed Informed consent document Exclusion Criteria: - under 13 years old - have already begun Chemo or radiotherapy


NCT ID:

NCT02431000


Primary Contact:

Principal Investigator
Laura Detti, M.D.
Associate Professor, UTennessee Health Science Center

Laura Detti, M.D
Phone: 901-448-1622
Email: ldetti@uthsc.edu


Backup Contact:

Email: abpayne@uthsc.edu
Annette B. Hickerson, R.N.
Phone: 901-448-4784


Location Contact:

Memphis, Tennessee 38119
United States

Laura Detti, M.D.
Phone: 901-515-3100
Email: ldetti@uthsc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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