NCT06951282

Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the potential protective role of selenium on semen parameters and its effect on seminal glutathione peroxidase level in patients on MTX therapy

Detailed description

The aim of this study is to assess the potential protective role of selenium on semen parameters and its effect on seminal glutathione peroxidase level in patients on MTX therapy. informed consent was obtained from each patient after explanation of the purpose of the study. All patients were subjected to history taking and general and local examination. Baseline semen analysis and seminal glutathione peroxidase (GPX) were done for all patients and then they were divided into four groups each has 10 patients. The no Se or MTX group was not eligible for neither Se nor MTX intake. The Se group started Se intake in a daily dose of 200 µg according to the United States National Academy of Sciences for 3 months. Patients of both MTX groups (MTX group \& MTX and Se group) were chosen from psoriatic patients already planned to start MTX treatment with subcutaneous dose of 0.3-0.4 mg/kg/week. The MTX and Se group started Se intake in a daily dose of 200 µg according to the United States National Academy of Sciences for 3 months. After 3 months, semen analysis and seminal GPX level were repeated.

Conditions

• Methotrexate Spermatotoxicity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Selenium	200 microgram selenium was given daily for 3 months
DRUG	Methotrexate	0.4 mg/kg/week sub cutaneous methotrexate for 3 months

Timeline

• Start date: 2024-05-02
• Primary completion: 2024-11-02
• Completion: 2024-12-31
• First posted: 2025-04-30
• Last updated: 2025-04-30

Locations

1 site across 1 country: Egypt