Infertility. Male infertility
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All men diagnosed with infertility or sperm analysis disorders People with gingivitis or mild to moderate periodontitis Willingness to participate in the study and provision of written informed consent Men with a minimum age of 20 and a maximum age of 50
Exclusion criteria
Exclusion criteria: Known genetic causes of infertility (e.g., genetic azoospermia) Presence of significant systemic diseases (e.g., diabetes, hormonal disorders) that may affect fertility History of testicular abnormalities (e.g., testicular atrophy, cryptorchidism, hypogonadism) History of testicular trauma or surgery Chronic prostatitis Varicocele Major viral infections (e.g., hepatitis) Previous infertility interventions or related surgeries (e.g., IVF or other assisted reproductive techniques)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Semen volume: Total ejaculate volume (mL). Sample collected by masturbation into a sterile plastic container after 3–5 days of sexual abstinence. Timepoint: Pre-intervention and 3 months post-intervention. Method of measurement: Measured in mL using a graduated pipette or calibrated cylinder after complete liquefaction, following WHO guidelines. Analysis performed within 30 minutes of collection.;Sperm concentration: Number of spermatozoa per milliliter of ejaculate (million sperm/mL). Timepoint: Pre-intervention and 3 months post-intervention. Method of measurement: Determined using a Neubauer hemocytometer (manual count) or Computer-Assisted Semen Analysis (CASA) if available, according to WHO guidelines. Sample collected after 3–5 days abstinence and analyzed within 30 minutes. Reported as million sperm/mL.;Sperm motility: Percentage of motile sperm in the sample (total motility = progressive + non-progressive). Progressive motility may be reported separately if required. Timepoint: Pre-intervention and 3 months post-intervention. Method of measurement: Assessed by light microscopy (typically ×400) according to WHO criteria; percentage of motile sperm recorded. If CASA is used, motility subcategories (progressive, non-progressive, immotile) will be reported. Analysis within 30 minutes of collection.;Sperm morphology: Percentage of sperm with normal morphology according to the WHO morphology criteria. Timepoint: Pre-intervention and 3 months post-intervention. Method of measurement: Slides prepared and stained and morphology assessed under microscopy according to WHO criteria. Results reported as percentage normal forms. Assessment performed by trained personnel. | — |
Secondary
| Measure | Time frame |
|---|---|
| Periodontal status: Gingivitis, Mild Periodontitis, Moderate Periodontitis, Healthy. Timepoint: Pre-intervention and 3 months post-intervention. Method of measurement: Periodontal assessment includes Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), Clinical Attachment Loss (CAL), and Bleeding on Probing (BOP). Indices are recorded according to Silness and Löe criteria. PD measured at six sites per tooth; CAL reported in millimeters. Periodontal status classified as Gingivitis (=2 sites with GI>0, no CAL) or Periodontitis (presence of CAL), further categorized by severity: Mild (1–2 mm CAL), Moderate (3–4 mm CAL), or Healthy. | — |
Countries
Iran (Islamic Republic of)
Contacts
Birjand University of Medical Sciences