NCT06951282

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

April 4, 2025

Last Update Submit

April 26, 2025

Conditions

Methotrexate Spermatotoxicity

Outcome Measures

Primary Outcomes (6)

  • Glutathione peroxidase level

    Seminal glutathione peroxidase level was measured in the four studied groups at baseline and after 3 month duration

    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

    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

    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

    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

    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

    from enrollment to 3 months

Study Arms (4)

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

Dietary Supplement: Selenium

Methotrexate group

ACTIVE COMPARATOR

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

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

Dietary Supplement: SeleniumDrug: Methotrexate

Interventions

SeleniumDIETARY_SUPPLEMENT

200 microgram selenium was given daily for 3 months

Selenium and methotrexate groupSelenium group
MethotrexateDRUG

0.4 mg/kg/week sub cutaneous methotrexate for 3 months

Methotrexate groupSelenium and methotrexate group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 00202, Egypt

Location

MeSH Terms

Interventions

SeleniumMethotrexate

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMineralsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 30, 2025

Study Start

May 2, 2024

Primary Completion

November 2, 2024

Study Completion

December 31, 2024

Last Updated

April 30, 2025

Record last verified: 2025-03

Locations

EG(1)