Male infertility. Male infertility
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Iranian academic center for education culture and research