Clinical trial NCT06951282: Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study
Official title: Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Methotrexate Spermatotoxicity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glutathione peroxidase level
timeFrame: from enrollment to 3 months
measure: semen volume
timeFrame: from enrollment to 3 months
measure: Sperm count / ejaculate
timeFrame: from enrollment to 3 months
measure: Sperm concentration / ml
timeFrame: from enrollment to 3 months
measure: Sperm motility
timeFrame: from enrollment to 3 months
measure: Sperm morphology
timeFrame: from enrollment to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
References: