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Evaluation of the effects of combined antioxidant supplements on sperm quality in infertile men

Evaluating the Effects of Different Combined Antioxidant Regimens on Sperm Parameters, DNA Fragmentation, and Chromatin Integrity in Men

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251219068382N1
Enrollment
90
Registered
2026-04-26
Start date
2026-04-04
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male infertility. Male infertility

Interventions

Intervention 1: Intervention group 1:Participants in this group will receive oral Selenium (200 µg/day, in the form of selenomethionine) together with L-carnitine tartrate (2000 mg/day). L-carnitine w

Sponsors

Iranian academic center for education culture and research
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Men aged 20 to 45 years No history of diabetes or hypertension Diagnosed with male factor infertility Body Mass Index less than 30 No varicocele No use of medications affecting sperm parameters

Exclusion criteria

Exclusion criteria: Sperm concentration less than 10 million per milliliter Occupations associated with severe heat or stress Cigarette smoking, alcohol consumption, or substance abuse Presence of systemic diseases affecting male fertility

Design outcomes

Primary

MeasureTime frame
Percentage of spermatozoa with deoxyribonucleic acid fragmentation in semen samples. Timepoint: At baseline (before intervention) and after completion of the intervention period (12 weeks). Method of measurement: Sperm DNA fragmentation was assessed using a standardized laboratory assay (e.g., Sperm Chromatin Dispersion test) according to the manufacturer’s instructions.;Sperm chromatin integrity index in semen samples. Timepoint: At baseline before initiation of supplementation and at the end of the intervention period on days 75 to 90. Method of measurement: Sperm chromatin integrity will be evaluated using Chromomycin A3 staining. After preparation and fixation of semen smears, samples will be stained with Chromomycin A3 dye. Fluorescence intensity will be assessed using a fluorescence microscope. The percentage of spermatozoa showing positive fluorescence will be calculated as an indicator of abnormal chromatin packaging and reduced chromatin integrity.

Secondary

MeasureTime frame
Sperm concentration per milliliter of semen. Timepoint: At baseline (before intervention) and after completion of the intervention period (12 weeks). Method of measurement: Sperm concentration will be measured using semen analysis according to the World Health Organization laboratory manual guidelines with the use of a Makler counting chamber or Neubauer hemocytometer in a specialized andrology laboratory.;Percentage of total sperm motility in semen samples. Timepoint: At baseline (before intervention) and after completion of the intervention period (12 weeks). Method of measurement: Total sperm motility will be assessed by microscopic evaluation of fresh semen samples according to the World Health Organization laboratory manual criteria.;Percentage of spermatozoa with normal morphology in semen samples. Timepoint: At baseline (before intervention) and after completion of the intervention period (12 weeks). Method of measurement: Sperm morphology will be evaluated using Papanicolaou staining and microscopic assessment according to strict World Health Organization criteria.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohsen Miresmaeili

Iranian academic center for education culture and research

miresmaeili @ sau.ac.ir+98 35 3826 4080

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026