Clinical Trial: Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Temozolomide Induced Changes in Semen/Sperm Analysis in Men With Newly Diagnosed, Progressive or Recurrent Primary Malignant Brain Tumors

Brief Summary:

RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors may help doctors learn about the long-term effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.


Detailed Summary:

OBJECTIVES:

Primary

  • Assess if temozolomide induces any changes in standard semen or sperm analysis parameters (i.e., volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology) in patients with newly diagnosed, recurrent, or progressive primary malignant brain tumors.

OUTLINE: This is a pilot study.

During treatment with temozolomide, patients undergo semen or sperm sample collection at baseline, 3 months, and 6 months for semen analysis. Samples are analyzed for volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: assess any changes in standard semen/sperm analysis parameters [ Time Frame: 6 months ]

assess if Temozolomide induces any changes in standard semen/sperm analysis parameters (volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology)


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Wake Forest University Health Sciences

Dates:
Date Received: July 10, 2007
Date Started: August 2004
Date Completion:
Last Updated: January 17, 2017
Last Verified: July 2013