Cancer Clinical Trial
Official title:
Male Fertility Pre- and Post- Radiation and Chemotherapy, and Sperm Preservation
NCT number | NCT02431000 |
Other study ID # | 12-02277-XP |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | June 30, 2020 |
Verified date | January 2019 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 13 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Tennessee Health Science Center Center for Reproductive Medicine, ROH, | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee |
United States,
Bahadur G. Fertility issues for cancer patients. Mol Cell Endocrinol. 2000 Nov 27;169(1-2):117-22. Review. — View Citation
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):3256-6 — View Citation
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. 200 — View Citation
Puscheck E, Philip PA, Jeyendran RS. Male fertility preservation and cancer treatment. Cancer Treat Rev. 2004 Apr;30(2):173-80. Review. — View Citation
Rofeim O, Gilbert BR. Normal semen parameters in cancer patients presenting for cryopreservation before gonadotoxic therapy. Fertil Steril. 2004 Aug;82(2):505-6. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Semen and lab parameters pre-cancer treatment. | •Semen Collection during an office visit. If no sample is able to be collected at that time, the visit may be rescheduled for another day. Also, 2 tablespoons of blood will be drawn from the arm by needle stick for hormonal blood tests. Information such as age, weight, and height, and medical history such as previous health problems will be copied from the medical record. | On Day 1/Visit 1 (1 hour and 30 minutes) | |
Primary | Semen and lab parameters post-cancer treatment. | Semen Collection during an office visit. If no sample is able to be collected at that time, the visit may be rescheduled for another day. Also, 2 tablespoons of blood will be drawn from the arm by needle stick for hormonal blood tests. Information such as age, weight, and height, and medical history such as previous health problems will be copied from the medical record. | Day 2/ Visit 2; 4 months after the completion of chemotherapy or radiotherapy | |
Secondary | Pre-therapy thawing evaluation of specific biochemical markers in the serum and in semen samples. | Semen will be frozen following existing freezing protocols. Fifty microliters (50 mL), each specimen, will be stored in formalin for later immunohistochemical examination. Fifty mLs will be frozen for metabolite, protein, and messenger Ribonucleic Acid (mRNA) analyses. These analyses will allow us to understand which sperm function is altered by cancer treatment and possibly identify protective measures to prevent such damage. Analyses will be conducted for all samples in the laboratory of the University of Tennessee Center for Reproductive Medicine at the University of Tennessee Health Science Center. This will allow us to have the same reference ranges for each of the different parameters measured and have a homogeneous evaluation of the results. The sperm specimens will be kept in the laboratory until analyzed and/or until completion of the research study.
Serum hormones levels of all samples from thawed serum samples will be analyzed in a central laboratory (LabCorp). |
On average,analysis will occur within 6 months of the completion of the subject's participation. | |
Secondary | Post-therapy thawing evaluation of specific biochemical markers in the serum and in semen samples. | Semen will be frozen following existing freezing protocols. Fifty mLs of each specimen will be stored in formalin for later immunohistochemical examination. Another 50 mLs will be frozen for metabolite, protein, and messenger Ribo Nucleic Acid analyses. These analyses will allow us to understand which sperm function is altered by cancer treatment and possibly identify protective measures to prevent such damage. Analyses will be conducted for all samples in the laboratory of the University of Tennessee Center for Reproductive Medicine at the University of Tennessee Health Science Center. This will allow us to have the same reference ranges for each of the different parameters measured and have a homogeneous evaluation of the results. The sperm specimens will be kept in the laboratory until analyzed and/or until completion of the research study.
Serum levels of the various hormones will be evaluated for all samples from thawed serum samples in a central laboratory (LabCorp). |
On average,analysis will occur within 6 months of the completion of the subject's participation. |
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