NCT00499798

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Brain and Central Nervous System Tumors
• Chemotherapeutic Agent Toxicity
• Infertility

Timeline

• Start date: 2004-08-01
• Primary completion: 2009-06-01
• Completion: 2014-09-01
• First posted: 2007-07-11
• Last updated: 2017-05-30

Locations

1 site across 1 country: United States