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IRCT20230403057812N1 IRCT 2023-06-10 Mashhad University of Medical Sciences Omega-3 supplementation in infertile men Effect of omega-3 supplementation on semen profile (semen volume, sperm count, sperm motility, sperm morphology) in infertile men 2023-07-01 anticipated 58 Complete https://irct.ir/trial/69444 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be determined by random block method with blocks of 4 and using random numbers table of Random Allocation Software. Blocking and allocation sequence for concealment will be done by a person not involved in the research. Allocation ratio of samples will be 1:1 and they will be placed in two groups. Then, based on the obtained blocks and according to the allocation sequence, the drugs will be given to the patients. The method is that we determine the number of blocks according to the sample size. Each block is numbered and is used for 4 patients. For example, if block number 2 is selected and its treatment group is ABAB, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment A, and the fourth patient will receive treatment B, Blinding description: After obtaining consent, the patients are included in the study and then they are divided into two control and intervention groups. Because the patients of the control group receive placebo, the intervention and control groups will not be distinguishable. Medicine and placebo are completely similar to each other in terms of shape, color and route of administration. 3 male infertility. Intervention 1: Intervention group: in this group, in addition to routine treatment, oral omega-3 treatment with a dose of 1000 mg per day is performed for 3 months. According to the time period of spermatogenesis (about 74 days) and previous studies, the treatment time with Omega 3 supplement was three months and its dose was considered to be 1000 mg daily. Due to the different dose of docosahexaenoic acid (DHA) in omega 3 thousand mg supplements available in Iran, for all patients, an omega 3 supplement containing the same amount of DHA (about 465 mg) is used. In this study, the capsule made by Karen company is used. Intervention 2: Control group: in the control group, in addition to the necessary and routine treatments to improve the spermogram disorder, a placebo is used daily for three months. Placebo capsule is prepared from Tasnim company. 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 There is no further information
public Niki Taziki
Faculty of Medicine, East Gate of University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 tazikin951@mums.ac.ir Mashhad University of Medical Sciences scientific Niki Taziki
Faculty of Medicine, East Gate of University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 tazikin951@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Infertile men aged 20-45 years with abnormal spermogram Not taking omega 3 supplements in the last 6 months 20 years 45 years Male Presence of known underlying disease for spermogram disorder Smoking and alcohol consumption Having jobs where there is a possibility of damage to sperm DNA due to high temperature N46.1 Oligospermia Treatment - Drugs Placebo Intervention group: in this group, in addition to routine treatment, oral omega-3 treatment with a dose of 1000 mg per day is performed for 3 months. According to the time period of spermatogenesis (about 74 days) and previous studies, the treatment time with Omega 3 supplement was three months and its dose was considered to be 1000 mg daily. Due to the different dose of docosahexaenoic acid (DHA) in omega 3 thousand mg supplements available in Iran, for all patients, an omega 3 supplement containing the same amount of DHA (about 465 mg) is used. In this study, the capsule made by Karen company is used. Control group: in the control group, in addition to the necessary and routine treatments to improve the spermogram disorder, a placebo is used daily for three months. Placebo capsule is prepared from Tasnim company. Spermogram disorders (semen fluid volume, sperm count, sperm movement rate, sperm shape). Timepoint: At the beginning of the study, the spermogram sample is examined, and then after three months of daily consumption of omega-3 tablets, the spermogram sample is examined again. Method of measurement: Sperm sample analyzer. Mashhad University of Medical Sciences Approved 2022-05-31 Ethics committee of Mashhad University of Medical Sciences Faculty of Medicine, University Campus, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)