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IRCT20211217053436N1 IRCT 2022-01-27 Mashhad University of Medical Sciences The effect of varicocelectomy and mast cell stabilizer on sperm DNA fragmentation effect of varicocelectomy and/or mast cells stabilizer on sperm DNA fragmentation in infertile patients with varicocele 2020-08-29 anticipated 123 Complete https://irct.ir/trial/60824 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using Excel software or dedicated randomization sites. Each group is assigned a code (for example, A, B, C). We write the codes in the order of the specified order on separate sheets. We put each sheet in a separate concealment envelope and close the lid. After referring each qualified patient and obtaining informed consent from him, an envelope is opened for the patient and according to the code written in it (A, B, C) the patient is placed in one of the three study groups. N/A Infertility caused by varicocele. Intervention 1: Control group: In the control group, individuals undergo only varicocelectomy microsurgery and the outcome is evaluated after 3 months. (Surgery only). Intervention 2: First Intervention group: Those who are treated with 1 mg of oral ketotifen tablet (Which were usually the product of various domestic pharmaceutical companies and no specific brand was considered.) twice a day for three months. (Pharmaceutical only). Intervention 3: Second Intervention group: Those who have undergone varicocelectomy microsurgery and are still treated daily with 1 mg of ketotifen tablet (Which were usually the product of various domestic pharmaceutical companies and no specific brand was considered.) for three months. (Both surgery and medication). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Until the sample volume capacity is completed
public Alireza Akhavan Rezayat
Ahmad Abad st.
Mashhad Iran (Islamic Republic of) 9178914833 +98 51 3843 2256 akhavanra@mums.ac.ir Mashhad University of Medical Sciences scientific Alireza Akhavan Rezayat
Ahmad Abad st.
Mashhad Iran (Islamic Republic of) 9178914833 +98 51 3843 2256 akhavanra@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Infertile men due to varicocele (in reproductive age) Informed consent no limit no limit Male Allergic reaction to drug Drug complication Leukocytospermia Azoospermia Diabetics I86.1 Scrotal varices Treatment - Surgery Treatment - Drugs Treatment - Other Control group: In the control group, individuals undergo only varicocelectomy microsurgery and the outcome is evaluated after 3 months. (Surgery only) First Intervention group: Those who are treated with 1 mg of oral ketotifen tablet (Which were usually the product of various domestic pharmaceutical companies and no specific brand was considered.) twice a day for three months. (Pharmaceutical only) Second Intervention group: Those who have undergone varicocelectomy microsurgery and are still treated daily with 1 mg of ketotifen tablet (Which were usually the product of various domestic pharmaceutical companies and no specific brand was considered.) for three months. (Both surgery and medication) Sperm DNA fragmentation. Timepoint: Before intervention and 3 months after intervention. Method of measurement: DNA Fragmentation Index percentage. Semen Analysis. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Semen Analysis. Mashhad University of Medical Sciences Approved 2021-01-26 Ethics committee of mashhad university of medical sciences Qaem hospital, urology department, Ahmad Abad street Mashhad Razavi Khorasan Iran (Islamic Republic of)