Short Term Genetic Effects of Chemotherapy on Male Germ Cells
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About
This study will determine the short-term effects of chemotherapy on sperm DNA.The study involves the collection of semen sample through ejaculation prior to initiation of chemotherapy and up to three time points after initiation of chemotherapy.
Full description
While medical advances in the area of cancer treatment have successfully improved the overall detection and treatment of many cancers affecting men and women alike, these very treatment modalities can adversely affect their reproductive capacity.
Certain types of chemotherapy, such as alkylating agents, are notorious for placing patients at high risk for infertility. For men, the best recommendation for patients undergoing such therapy is to cryopreserve semen prior to initiation of chemotherapy. Unfortunately, this may not always occur. Some patients have been noted to present to discuss fertility preservation options after completing their first cycle of chemotherapy. In this situation, they will most likely still have sperm which was produced prior to chemotherapy that can be collected even if the stem cells producing the sperm have been damaged or destroyed. However, there are no national guidelines addressing this particular situation. Typically, physicians may advise men to avoid conception anywhere from three months to two years after the final dose of chemotherapy to ensure all exposed germ cells have passed through and only newly formed germ cells remain.
It is crucial to further assess the effects of chemotherapeutic agents on male germ cells in the short window of time between exposure and potential sterility. If a safe time frame could be determined to collect sperm after a single dose of chemotherapy, then these men could be given a second chance to retain their fertility potential.
Enrollment
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Volunteers
Inclusion criteria
- Be scheduled to undergo treatment with chemotherapeutic agents for a medical indication
- Be able to produce semen samples prior to chemotherapy and one week after first round of chemotherapy
Exclusion criteria
- Men who have previously been treated with chemotherapeutic agents.
- Men with significant oligospermia or azospermia.
Trial design
200 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Rachel Neelley
Data sourced from clinicaltrials.gov
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