Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study

Ain Shams University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Methotrexate Spermatotoxicity

Treatments: Drug: Methotrexate; Dietary Supplement: Selenium

Study type: Interventional

Funder types: Other

Identifiers

NCT06951282

MD70/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

No selenium or methotrexate group

No Intervention group

Description:

no selenium or methotrexate were given

Selenium group

Active Comparator group

Description:

200 microgram selenium was given daily for 3 months

Treatment:

Dietary Supplement: Selenium

Methotrexate group

Active Comparator group

Description:

0.4 mg/kg/week subcutaneous methotrexate was given for 3 months

Treatment:

Drug: Methotrexate

Selenium and methotrexate group

Active Comparator group

Description:

200 microgram selenium was given daily for 3 months along with 0.4 mg/kg/week subcutaneous methotrexate for 3 months

Treatment:

Dietary Supplement: Selenium

Drug: Methotrexate