| Registry | NCT06951282 |
|---|---|
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 40 (Actual) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Methotrexate Spermatotoxicity |
| Interventions | Selenium, Methotrexate (Dietary supplement, drug) |
| Dates | start 2024-05-02, primary completion 2024-11-02, completion 2024-12-31, first posted 2025-04-30, last updated 2025-04-30 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Methotrexate Spermatotoxicity All trials of Selenium All trials of Methotrexate
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| No selenium or methotrexate group | No intervention | no selenium or methotrexate were given | |
| Selenium group | Active comparator | Dietary Supplement: Selenium | 200 microgram selenium was given daily for 3 months |
| Methotrexate group | Active comparator | Drug: Methotrexate | 0.4 mg/kg/week subcutaneous methotrexate was given for 3 months |
| Selenium and methotrexate group | Active comparator | Dietary Supplement: Selenium; Drug: Methotrexate | 200 microgram selenium was given daily for 3 months along with 0.4 mg/kg/week subcutaneous methotrexate for 3 months |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Ain Shams University | Cairo, Abbassia | Egypt |