Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study
- Conditions
- Methotrexate Spermatotoxicity
- Interventions
- Dietary Supplement: Selenium
- Registration Number
- NCT06951282
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Selenium group Selenium 200 microgram selenium was given daily for 3 months Methotrexate group Methotrexate 0.4 mg/kg/week subcutaneous methotrexate was given for 3 months Selenium and methotrexate group Selenium 200 microgram selenium was given daily for 3 months along with 0.4 mg/kg/week subcutaneous methotrexate for 3 months Selenium and methotrexate group Methotrexate 200 microgram selenium was given daily for 3 months along with 0.4 mg/kg/week subcutaneous methotrexate for 3 months
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ain Shams University
🇪🇬Cairo, Abbassia, Egypt