Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2015-05-31
2020-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Male Chemo/Radiotherapy Candidates
Adult and post-pubertal males, 13 years of age or older, presenting to clinic because diagnosed with cancer, who wish to preserve their future fertility. Sperm and blood collected for analysis. If minors, parents or guardians have to give consent to the procedure while the boys give their assent.
This is a prospective observational cohort study.
Sperm and blood collected for analysis
Sperm Collection and Freezing (Cryopreservation), Blood Collection for analysis
Interventions
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Sperm and blood collected for analysis
Sperm Collection and Freezing (Cryopreservation), Blood Collection for analysis
Eligibility Criteria
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Inclusion Criteria
* diagnosed with cancer, but not yet undergoing therapy
* willing to participate in this clinical trial
* signed Informed consent document
Exclusion Criteria
* have already begun Chemo or radiotherapy
13 Years
MALE
No
Sponsors
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University of Tennessee
OTHER
Responsible Party
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Principal Investigators
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Laura Detti, M.D.
Role: PRINCIPAL_INVESTIGATOR
Associate Professor, UTennessee Health Science Center
Locations
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University of Tennessee Health Science Center Center for Reproductive Medicine, ROH,
Memphis, Tennessee, United States
Countries
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References
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Bahadur G. Fertility issues for cancer patients. Mol Cell Endocrinol. 2000 Nov 27;169(1-2):117-22. doi: 10.1016/s0303-7207(00)00364-6.
Lee SJ, Schover LR, Partridge AH, Patrizio P, Wallace WH, Hagerty K, Beck LN, Brennan LV, Oktay K; American Society of Clinical Oncology. American Society of Clinical Oncology recommendations on fertility preservation in cancer patients. J Clin Oncol. 2006 Jun 20;24(18):2917-31. doi: 10.1200/JCO.2006.06.5888. Epub 2006 May 1.
Lass A, Akagbosu F, Abusheikha N, Hassouneh M, Blayney M, Avery S, Brinsden P. A programme of semen cryopreservation for patients with malignant disease in a tertiary infertility centre: lessons from 8 years' experience. Hum Reprod. 1998 Nov;13(11):3256-61. doi: 10.1093/humrep/13.11.3256.
Rofeim O, Gilbert BR. Normal semen parameters in cancer patients presenting for cryopreservation before gonadotoxic therapy. Fertil Steril. 2004 Aug;82(2):505-6. doi: 10.1016/j.fertnstert.2003.12.045.
Puscheck E, Philip PA, Jeyendran RS. Male fertility preservation and cancer treatment. Cancer Treat Rev. 2004 Apr;30(2):173-80. doi: 10.1016/j.ctrv.2003.07.005.
Sabanegh ES Jr, Ragheb AM. Male fertility after cancer. Urology. 2009 Feb;73(2):225-31. doi: 10.1016/j.urology.2008.08.474. Epub 2008 Nov 26.
Schover LR. Rates of postcancer parenthood. J Clin Oncol. 2009 Jan 20;27(3):321-2. doi: 10.1200/JCO.2008.19.7749. Epub 2008 Dec 15. No abstract available.
Skinner R, Wallace WH, Levitt GA; UK Children's Cancer Study Group Late Effects Group. Long-term follow-up of people who have survived cancer during childhood. Lancet Oncol. 2006 Jun;7(6):489-98. doi: 10.1016/S1470-2045(06)70724-0.
Williams DH 4th, Karpman E, Sander JC, Spiess PE, Pisters LL, Lipshultz LI. Pretreatment semen parameters in men with cancer. J Urol. 2009 Feb;181(2):736-40. doi: 10.1016/j.juro.2008.10.023. Epub 2008 Dec 16.
Other Identifiers
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12-02277-XP
Identifier Type: -
Identifier Source: org_study_id