Short Term Genetic Effects of Chemotherapy on Male Germ Cells

NCT ID: NCT02975245

Last Updated: 2025-09-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Men receiving chemotherapy

Semen collection and analysis

Semen collection and analysis

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Kyle Orwig

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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STUDY20040140

Identifier Type: -

Identifier Source: org_study_id

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