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Completed

NCT Number: NCT02975245

Short Term Genetic Effects of Chemotherapy on Male Germ Cells

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Semen collection and analysis

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2016
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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