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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Procedure: Semen collection and analysis

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: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males between the ages of 18 and 50 who are scheduled to undergo chemotherapy for medical indication.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Men receiving chemotherapy; Semen collection and analysis	Procedure: Semen collection and analysis; Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.

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.	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.	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: University of Pittsburgh
• Investigators: Principal Investigator: Kyle Orwig, PhD, University of Pittsburgh/University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimated): November 29, 2016

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Chemotherapy; Sperm; Male infertility; Germ cells
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility; Neoplasms; Infertility, Male
• Other Study ID Numbers: STUDY20040140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No