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Short Term Genetic Effects of Chemotherapy on Male Germ Cells

Short Term Genetic Effects of Chemotherapy on Male Germ Cells

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02975245
Enrollment
200
Registered
2016-11-29
Start date
2013-02-28
Completion date
2025-04-30
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Male infertility, Germ cells, Chemotherapy, Sperm

Brief summary

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.

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.

Interventions

PROCEDURESemen collection and analysis

Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the differences in DNA between sperm collected before chemotherapy to sperm collected after the first round of chemotherapy using whole exome sequencing.5 yearsSperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.

Secondary

MeasureTime frameDescription
changes in sperm quality from sperm collected before the initiation of chemotherapy to sperm collected after first round of chemotherapy using sperm count test.5 yearsSperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026