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This study investigates how mutations in the TDRD9 gene affect the response to L-carnitine treatment in men with oligoasthenozoospermia (low sperm count and motility). Men aged 20 to 50 who have been diagnosed with oligoasthenozoospermia and consent to procedures including genetic testing (TDRD9 analysis) may take part. The study is in Phase 3; it is active but not currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria Male participants aged 20-50 years Clinical diagnosis of oligoasthenozoospermia, confirmed by two semen analyses according to WHO 2010/2021 criteria: Sperm concentration \<15 million/mL, and Progressive motility \<32% Attempting conception with a partner for ≥12 months, or referred for infertility evaluation Willing and able to take oral L-carnitine and comply with all study visits and procedures Able and willing to provide written informed consent, including consent for genetic testing (TDRD9 analysis) Exclusion Criteria Known obstructive azoospermia Grade III varicocele requiring surgical correction, unless repaired ≥6 months prior to enrollment Use of fertility supplements or hormonal therapy within the 3 months prior to enrollment (washout required) Active genitourinary infection (e.g., prostatitis) or systemic illness known to affect fertility Known severe systemic disease, including uncontrolled diabetes mellitus or severe hepatic or renal disease Known hypersensitivity or allergy to L-carnitine History of testicular cancer or receipt of chemotherapy within the past 2 years