Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study

NCT06951282 — Phase 1 / Phase 2, Completed, 40 participants, Ain Shams University

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RegistryNCT06951282
StatusCompleted
PhasePhase 1 / Phase 2
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment40 (Actual)
SponsorAin Shams University (Other)
ConditionsMethotrexate Spermatotoxicity
InterventionsSelenium, Methotrexate (Dietary supplement, drug)
Datesstart 2024-05-02, primary completion 2024-11-02, completion 2024-12-31, first posted 2025-04-30, last updated 2025-04-30
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Methotrexate Spermatotoxicity All trials of Selenium All trials of Methotrexate

-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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
No selenium or methotrexate groupNo interventionno selenium or methotrexate were given
Selenium groupActive comparatorDietary Supplement: Selenium200 microgram selenium was given daily for 3 months
Methotrexate groupActive comparatorDrug: Methotrexate0.4 mg/kg/week subcutaneous methotrexate was given for 3 months
Selenium and methotrexate groupActive comparatorDietary Supplement: Selenium; Drug: Methotrexate200 microgram selenium was given daily for 3 months along with 0.4 mg/kg/week subcutaneous methotrexate for 3 months
  • 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

+Outcome measures

Primary outcomes

  • Glutathione peroxidase level [from enrollment to 3 months]: Seminal glutathione peroxidase level was measured in the four studied groups at baseline and after 3 month duration
  • semen volume [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
  • Sperm count / ejaculate [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
  • Sperm concentration / ml [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
  • Sperm motility [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
  • Sperm morphology [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

+Eligibility

Sex: Male, ages: 18 Years to 60 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Ain Shams UniversityCairo, AbbassiaEgypt