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Completed

NCT Number: NCT06951282

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

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Key information

Conditions

Methotrexate Spermatotoxicity

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ain Shams University

Cairo, Abbassia, 00202, Egypt

About this 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selenium

Dietary Supplement

200 microgram selenium was given daily for 3 months

methotrexate

Drug

0.4 mg/kg/week sub cutaneous methotrexate for 3 months

Primary outcomes

  1. Glutathione peroxidase level

    Time frame: from enrollment to 3 months

    Seminal glutathione peroxidase level was measured in the four studied groups at baseline and after 3 month duration

  2. semen volume

    Time frame: from enrollment to 3 months

    Semen volume in (ml) was measured in all patients of the 4 studied groups at baseline and after 3 months

  3. Sperm count / ejaculate

    Time frame: from enrollment to 3 months

    Sperm count / ejaculate in (million) was measured in all patients of the 4 studied groups at baseline and after 3 months

  4. Sperm concentration / ml

    Time frame: from enrollment to 3 months

    Sperm concentration / ml in (million) was measured in all patients of the 4 studied groups at baseline and after 3 months

  5. Sperm motility

    Time frame: from enrollment to 3 months

    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

  6. Sperm morphology

    Time frame: from enrollment to 3 months

    percentage of sperms with normal morphology was measured in all patients of the 4 studied groups at baseline and after 3 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.