An observational study in Cancer, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by University of Pittsburgh · Observational
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 200 is close to the median of 204 across 1,683 observational studies indexed under Neoplasms.
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Males between the ages of 18 and 50 who are scheduled to undergo chemotherapy for medical indication.
Exclusion Criteria:
Semen collection and analysis
Procedure: Semen collection and analysis
Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.
the differences in DNA between sperm collected before chemotherapy to sperm collected after the first round of chemotherapy using whole exome sequencing.
Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.
Time frame: 5 years
changes in sperm quality from sperm collected before the initiation of chemotherapy to sperm collected after first round of chemotherapy using sperm count test.
Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.
Time frame: 5 years
Plan to share: Undecided
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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