Unexplained Male Infertility. Male infertility, unspecified
Conditions
Interventions
Intervention group: Participants receive one tablet containing Bifidobacterium longum at a dose of ten to the power of nine colony-forming units in the form of WellGut IBS tablets and one sachet of po
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Normal semen parameters DNA Fragmentation Index ( DFI) > 20% Age range 20 to 45 years No history of genetic diseases No history of reproductive system-related disorders No history of reproductive system-related surgeries Abstinence from sexual intercourse for 2 to 3 days
Exclusion criteria
Exclusion criteria: Obesity Endocrine disorders and reproductive system-related diseases Presence of varicocele History of cardiovascular diseases History of sexually transmitted infections (STIs) Acute urinary tract infection (including Mycoplasma or Chlamydia) Leukocytospermia Exposure to toxic substances affecting the reproductive system Smoking or alcohol consumption Individuals with Klinefelter syndrome History of endocrine disorders or reproductive system-related diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sperm DNA fragmentation index (DNA Fragmentation Index, DFI). Timepoint: Baseline (before the first dose); after 10 weeks of daily probiotic supplementation (post-final dose). At each time point, semen samples are collected after 2 to 3 days of sexual abstinence. Method of measurement: Sperm DNA Fragmentation Index (DFI) is measured using the Sperm Chromatin Dispersion (SCD) assay with a commercial kit according to the manufacturer’s instructions. At least 300 spermatozoa per sample are assessed and the percentage of sperm with fragmented DNA is calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sperm parameters according to World Health Organization 2021 guidelines. Timepoints. Timepoint: Before starting probiotic supplementation and after 10 weeks of daily consumption. Method of measurement: Semen analysis according to World Health Organization 2021.;Oxidative stress (ROS) in semen plasma. Timepoint: Before starting probiotic supplementation and after 10 weeks of daily consumption. Method of measurement: Measurement of Oxidative Stress (ROS) Using a Specific Diagnostic Kit and Photometric Method.;Total antioxidant capacity in semen plasma. Timepoint: Before starting probiotic supplementation and after 10 weeks of daily consumption. Method of measurement: Total Antioxidant Capacity Measurement Using Specific Diagnostic Kit and Photometric Method.;The concentration of Interleukin-1 beta in the seminal plasma. Timepoint: Before starting probiotic supplementation and after 10 weeks of daily consumption. Method of measurement: Measured using specific enzyme-linked immunosorbent assay kits according to the manufacturer’s instructions.;The concentration of Interleukin-6 in the seminal plasma. Timepoint: Before starting probiotic supplementation and after 10 weeks of daily consumption. Method of measurement: Measured using specific enzyme-linked immunosorbent assay kits according to the manufacturer’s instructions.;The concentration of Tumor Necrosis Factor alpha in the seminal plasma. Timepoint: Before starting probiotic supplementation and after 10 weeks of daily consumption. Method of measurement: Measured using specific enzyme-linked immunosorbent assay kits according to the manufacturer’s instructions.;The concentration of Nuclear Factor kappa B in the seminal plasma. Timepoint: Before starting probiotic supplementation and after 10 weeks of daily consumption. Method of measurement: Measured using specific enzyme-linked immunosorbent assay kits according to the manufacturer’s instructions.;Identification of microplastic polymer types (PVC, PS, PP, PE, etc.) | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZohreh Nazmara
Iran University of Medical Sciences
Outcome results
None listed