Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study

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

Study Overview

• Status: Completed
• Conditions: Methotrexate Spermatotoxicity
• Intervention / Treatment: Dietary supplement: Selenium; Drug: Methotrexate

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 00202
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• adult males from 18-60 years old for the 2 methotrexate (MTX) study groups, the males included were chosen from patients already planned to start MTX treatment for psoriasis

Exclusion Criteria:

• History of drug intake that can affect semen parameters i.e., cytotoxic drugs, anti-androgens, sulfasalazine, gonadal hormones, nitrofurans or salicylic acid within previous three months.
• History of smoking within the last three months.
• Chronic disorders such as diabetes mellitus, hypertension, obesity, chronic liver or renal disease.
• Organic diseases that can affect fertility i.e., varicocele, testicular tumor or undescended testis.
• Genitourinary diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No selenium or methotrexate group; no selenium or methotrexate were given
Active Comparator: Selenium group; 200 microgram selenium was given daily for 3 months	Dietary supplement: Selenium; 200 microgram selenium was given daily for 3 months
Active Comparator: Methotrexate group; 0.4 mg/kg/week subcutaneous methotrexate was given for 3 months	Drug: Methotrexate; 0.4 mg/kg/week sub cutaneous methotrexate for 3 months
Active Comparator: Selenium and methotrexate group; 200 microgram selenium was given daily for 3 months along with 0.4 mg/kg/week subcutaneous methotrexate for 3 months	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glutathione peroxidase level	Seminal glutathione peroxidase level was measured in the four studied groups at baseline and after 3 month duration	from enrollment to 3 months
semen volume	Semen volume in (ml) was measured in all patients of the 4 studied groups at baseline and after 3 months	from enrollment to 3 months
Sperm count / ejaculate	Sperm count / ejaculate in (million) was measured in all patients of the 4 studied groups at baseline and after 3 months	from enrollment to 3 months
Sperm concentration / ml	Sperm concentration / ml in (million) was measured in all patients of the 4 studied groups at baseline and after 3 months	from enrollment to 3 months
Sperm motility	percentage of sperm progressive, non progressive and total motility were measured in all patients of the 4 studied groups at baseline and after 3 months	from enrollment to 3 months
Sperm morphology	percentage of sperms with normal morphology was measured in all patients of the 4 studied groups at baseline and after 3 months	from enrollment to 3 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Actual): November 2, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Antimetabolites, Antineoplastic; Antimetabolites; Dermatologic Agents; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Trace Elements; Micronutrients; Antioxidants; Protective Agents; Methotrexate; Selenium
• Other Study ID Numbers: MD70/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No