Short Term Genetic Effects of Chemotherapy on Male Germ Cells

Cancer Clinical Trial

Official title:

Short Term Genetic Effects of Chemotherapy on Male Germ Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02975245
• Other study ID #: PRO12080254
• Status: Recruiting
• Start date: February 2013
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Rachel Neelley
• Phone: 412-641-7475
• Email: fertilitypreservation[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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