Short Term Genetic Effects of Chemotherapy on Male Germ Cells
NCT ID: NCT02975245
Last Updated: 2025-09-19
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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COMPLETED
200 participants
OBSERVATIONAL
2013-02-28
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Men receiving chemotherapy
Semen collection and analysis
Semen collection and analysis
Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.
Interventions
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Semen collection and analysis
Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* Be able to produce semen samples prior to chemotherapy and one week after first round of chemotherapy
Exclusion Criteria
* Men with significant oligospermia or azospermia.
18 Years
50 Years
MALE
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Kyle Orwig
Professor
Principal Investigators
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Kyle Orwig, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh/University of Pittsburgh Medical Center
Locations
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Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY20040140
Identifier Type: -
Identifier Source: org_study_id
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