Methotrexate Spermatotoxicity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSelenium
200 microgram selenium was given daily for 3 months
DRUGMethotrexate
0.4 mg/kg/week sub cutaneous methotrexate for 3 months
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed