NCT02975245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

12.2 years

First QC Date

November 21, 2016

Last Update Submit

September 15, 2025

Conditions

Cancer

Keywords

Male infertilityGerm cellsChemotherapySperm

Outcome Measures

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.

    Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.

    5 years

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.

    5 years

Study Arms (1)

Men receiving chemotherapy

Semen collection and analysis

Procedure: Semen collection and analysis

Interventions

Semen collection and analysisPROCEDURE

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

Men receiving chemotherapy

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Men who have previously been treated with chemotherapeutic agents.
  • Men with significant oligospermia or azospermia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Semen sample

MeSH Terms

Conditions

NeoplasmsInfertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Kyle Orwig, PhD

    University of Pittsburgh/University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 29, 2016

Study Start

February 1, 2013

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

US(1)