Short Term Genetic Effects of Chemotherapy on Male Germ Cells
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Magee-Womens Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Men receiving chemotherapy
Semen collection and analysis
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Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the differences in DNA between sperm collected before chemotherapy to sperm collected after the first round of chemotherapy using whole exome sequencing.
Time Frame: 5 years
|
Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in sperm quality from sperm collected before the initiation of chemotherapy to sperm collected after first round of chemotherapy using sperm count test.
Time Frame: 5 years
|
Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kyle Orwig, PhD, University of Pittsburgh/University of Pittsburgh Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20040140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
product manufactured in and exported from the U.S.
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