Methotrexate SpermatotoxicityPhase 1/2NCT06951282
Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study
A Phase 1/2 study testing Selenium and Methotrexate in people with Methotrexate Spermatotoxicity, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Methotrexate Spermatotoxicity
- What is being tested?
- Selenium and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2024to 31 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Methotrexate Spermatotoxicity
- Being tested
- Selenium, Methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDietary supplement
200 microgram selenium was given daily for 3 months
MethotrexateDrug
0.4 mg/kg/week sub cutaneous methotrexate for 3 months
| Study group | Role | What they receive |
|---|---|---|
| No selenium or methotrexate group | No intervention | no selenium or methotrexate were given |
| Selenium group | Active comparator | 200 microgram selenium was given daily for 3 months Receives: Dietary Supplement: Selenium |
| Methotrexate group | Active comparator | 0.4 mg/kg/week subcutaneous methotrexate was given for 3 months Receives: Drug: Methotrexate |
| Selenium and methotrexate group | Active comparator | 200 microgram selenium was given daily for 3 months along with 0.4 mg/kg/week subcutaneous methotrexate for 3 months Receives: Dietary Supplement: Selenium; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutathione peroxidase level
Seminal glutathione peroxidase level was measured in the four studied groups at baseline and after 3 month duration
Measured: from enrollment to 3 months
semen volume
Semen volume in (ml) was measured in all patients of the 4 studied groups at baseline and after 3 months
Measured: from enrollment to 3 months
Sperm count / ejaculate
Sperm count / ejaculate in (million) was measured in all patients of the 4 studied groups at baseline and after 3 months
Measured: from enrollment to 3 months
Sperm concentration / ml
Sperm concentration / ml in (million) was measured in all patients of the 4 studied groups at baseline and after 3 months
Measured: from enrollment to 3 months
Sperm motility
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
Measured: from enrollment to 3 months
Sperm morphology
percentage of sperms with normal morphology was measured in all patients of the 4 studied groups at baseline and after 3 months
Measured: from enrollment to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start2 May 2024
- Primary completion2 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methotrexate SpermatotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951282
- Sponsor's protocol ID
- MD70/2024
- Status last verified
- Mar 2025
- First submitted
- 4 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study
- ClinicalTrials.gov ID
- NCT06951282
- Acronym / sponsor ID
- MD70/2024
- Conditions
- Methotrexate Spermatotoxicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No selenium or methotrexate group | No intervention | –no selenium or methotrexate were given |
| Selenium group | Active comparator | Dietary Supplement: Selenium200 microgram selenium was given daily for 3 months |
| Methotrexate group | Active comparator | Drug: Methotrexate0.4 mg/kg/week subcutaneous methotrexate was given for 3 months |
| Selenium and methotrexate group | Active comparator | Dietary Supplement: Selenium, Drug: Methotrexate200 microgram selenium was given daily for 3 months along with 0.4 mg/kg/week subcutaneous methotrexate for 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selenium200 microgram selenium was given daily for 3 months | Dietary supplement | Selenium and methotrexate group, Selenium group |
| Methotrexate0.4 mg/kg/week sub cutaneous methotrexate for 3 months | Drug | Methotrexate group, Selenium and methotrexate group |
Primary outcome
Glutathione peroxidase level
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Selenium and Methotrexate in people with Methotrexate Spermatotoxicity, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glutathione peroxidase level (time frame: from enrollment to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.