Varicocele. Scrotal varices
Conditions
Interventions
Intervention 1: Intervention group: Participants allocated to the lycopene group will receive oral lycopene supplementation at a dose of 20 mg daily for 12 weeks following microsurgical varicocelectom
Sponsors
Artesh University of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Male participants aged 18–45 years with a clinical diagnosis of unilateral or bilateral varicocele (grade 2 or 3 according to the Dubin and Amelar classification) impaired semen quality based on WHO 2021 criteria (including sperm concentration <15 × 106/mL, total motility <40%, progressive motility <32%, or normal morphology <4%) a documented history of infertility defined as failure to achieve pregnancy after at least 12 months of unprotected intercourse candidates for elective microsurgical varicocelectomy willingness to comply with the study protocol and provide written informed consent
Exclusion criteria
Exclusion criteria: Presence of systemic diseases affecting fertility (such as diabetes mellitus, thyroid disorders, or other endocrine abnormalities) use of fertility-related treatments, antioxidants, or nutritional supplements within the preceding 6 months current or recent (within the past 6 months) tobacco use or excessive alcohol consumption (>14 units per week) body mass index (BMI) greater than 30 kg/m² istory of testicular malignancy, cryptorchidism, orchitis, or other contraindications to surgery; abnormal baseline hormonal profiles (including elevated FSH or LH levels or reduced testosterone suggestive of primary testicular failure) positive semen culture indicating genital tract infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sperm concentration(×106/mL). Timepoint: Baseline (pre-surgery) and 12 weeks post-surgery. Method of measurement: Semen analysis according to WHO 2021 guidelines.;Total sperm motility (%). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: WHO 2021 semen analysis.;Progressive sperm motility (%). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: WHO 2021 semen analysis.;Normal sperm morphology (%). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: WHO 2021 semen analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Antioxidant Capacity (TAC, mmol/L). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: spectrophotometric assay.;Total Oxidant Status (TOS, µmol/L). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: spectrophotometric assay.;Oxidative Stress Index (OSI, AU). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: Calculated from TAC and TOS values.;Serum Follicle-stimulating hormone (FSH, mIU/mL). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: chemiluminescence immunoassay.;Serum Luteinizing hormone (LH, mIU/mL). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: chemiluminescence immunoassay.;Serum total testosterone (ng/dL). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: Chemiluminescence immunoassay.;Sperm DNA Fragmentation Index (DFI, %). Timepoint: Baseline and 12 weeks post-surgery. Method of measurement: TUNNEL assay.;Adverse events. Timepoint: throughout the 12-week study period. Method of measurement: standardized questionnaires. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArya Behzadi
Artesh University of Medical Sciences
Outcome results
None listed