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IRCT20200122046220N2 IRCT 2021-04-04 Artesh University of Medical Sciences Evaluation of varicocele surgery on deoxyribonucleic acid fragmentation index Evaluation of the effect of new method of varicocele surgery (gobernectomy and) on fertility based on DNA fragmentation index 2020-09-22 anticipated 80 Complete https://irct.ir/trial/50683 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization method was used to create a random sequence.We considered the block size to be 4 so that in each block 2 patients were operated by conventional method and two patients by conventional method + gubernaculectomy.We entered information about the block size and sample size into the sealedenvelope.com website to specify the desired sequence in each block.In this way, 20 blocks of size 4 were identified to randomize the sample size of 80.With this method, we were able to Divide patients into two groups in a balanced and unpredictable way.Also to hide random allocation , custom codes created by the same website were used for each person entered into the study, Blinding description: Participants do not know which surgical technique they undergo.Patients are not conscious during surgery.After surgery it is not possible for the patient to determine the type of technique due to the type of skin incision etc. N/A Infertility associated with varicocele and impaired DFI. Intervention 1: Control group: People over the age of 18 with varicocele and infertility who have impaired Deoxyribonucleic acid Fragmentation Index in semen analysis (DFI > 30%) undergoing varicocele surgery in a standard approach (Closing the spermatic vessels of the cord without the help of a microscope in the inguinal canal). Intervention 2: Intervention group: People over the age of 18 with varicocele and infertility who have impaired Deoxyribonucleic acid Fragmentation Index (DFI > 30%) in semen analysis undergoing varicocele surgery in a standard way plus gubernaculectomy. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: There are no restrictions Where to obtain: Arash Karimi arashkarimi1510@yahoo.com How to obtain: Access to data is done by sending an e-mail to the previous address Comments:
public Arash Karimi Baba Ahmadi
No. 9, Omranipour Alley , Golshan st., Azarbayjan Ave.
Tehran Iran (Islamic Republic of) 1318834651 +98 21 6693 8257 arashkarimi86@yahoo.com Artesh University of Medical Sciences scientific Arash Karimi
No. 9, Omranipour Alley , Golshan st., Azarbayjan Ave.
Tehran Iran (Islamic Republic of) 1318834651 +98 21 6693 8257 arashkarimi86@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Infertile people with second and third degree varicocele Impaired Deoxyribonucleic acid fragmentation index 18 years 50 years Male History of orchitis or testicular cancer Azoospermia History of inguinal or scrotal surgery Systemic inflammatory disease History of testicular trauma, Treatment - Surgery Treatment - Surgery Control group: People over the age of 18 with varicocele and infertility who have impaired Deoxyribonucleic acid Fragmentation Index in semen analysis (DFI > 30%) undergoing varicocele surgery in a standard approach (Closing the spermatic vessels of the cord without the help of a microscope in the inguinal canal) Intervention group: People over the age of 18 with varicocele and infertility who have impaired Deoxyribonucleic acid Fragmentation Index (DFI > 30%) in semen analysis undergoing varicocele surgery in a standard way plus gubernaculectomy Percentage of fertility and DFI improvement after surgery. Timepoint: DFI measurement before and three months after surgery. Method of measurement: Percentage of sperm with defective chromosomes to total sperms. Artesh University of Medical Sciences Approved 2021-01-06 Ethics committee of AJA University of Medical Sciences Unit 2, No. 9 Omrani Alley, Golshan intersection, Azarbayjan Ave. Tehran Tehran Iran (Islamic Republic of)