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IRCT20181030041503N4 IRCT 2021-08-18 Mashhad University of Medical Sciences The effect of an antioxidant on couple fertility with recurrent abortion Evaluation of the effect of alpha-lipoic acid antioxidant on sperm DNA Fragmentation in the treatment of recurrent abortion 2021-07-23 anticipated 40 Complete https://irct.ir/trial/57390 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization -In this randomized clinical trial 40 patients, two groups were randomly assigned. -Method used to generate random allocation sequence by mentioning the name of the software or site used: Computer random assignment list produced with PASS software, Blinding description: The patient is unaware of the treatment, patients are coded A and B based on random assignment, and the researcher gives the drug to the patient based on patient code A or B. The statistical consultant who analyzes the data is unaware of the grouping. 3 Male infertility. Intervention 1: The intervention group received 300 mg of alpha lipoic acid tablets made by the Raha Daroo Company, 3 daily for 3 months. Intervention 2: The placebo group also receives 300 mg tablets, very similar to the alpha-lipoic acid tablets made by the School of Pharmacy, 3 daily for 3 months This medicine is provided by Raha Daroo 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 I'm looking into the matter
public Fatemeh Shahabian moghaddam
Honarestan
Mashhad Iran (Islamic Republic of) 9178143179 +98 51 3883 0663 shahabianmf971@mums.ac.ir Mashhad University of Medical Sciences scientific Nayereh Khadem
خراسان رضوي، مشهد ،مركز نازايي ميلاد
Mashhad Iran (Islamic Republic of) 9135913556 +98 51 3583 1204 Khademn@mum.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Couples with a history of recurrent miscarriage and DFI >30% willingness to participate in the study Normal karyotype Thyroid, prolactin, and thrombophilic and phospholipid tests are normal no limit no limit Male PCO and chronic anovulation presence of tubal and anatomical disease of the uterus Dissatisfaction with participation in the study presence of underlying disease Allergic drug reaction Side effects of the drug such as hypotension and occasional hypoglycemia and anemia Not taking the medicine regularly N46.9 Male infertility, unspecified Treatment - Drugs Placebo The intervention group received 300 mg of alpha lipoic acid tablets made by the Raha Daroo Company, 3 daily for 3 months The placebo group also receives 300 mg tablets, very similar to the alpha-lipoic acid tablets made by the School of Pharmacy, 3 daily for 3 months This medicine is provided by Raha Daroo Company Examination of sperm DNA fragmentation. Timepoint: Before starting treatment and then, after 3 months of treatment. Method of measurement: Examination of blood samples using SCSA method. Mashhad University of Medical Sciences Approved 2021-07-06 Mashhad university of medical sciences Ethics committee Vice chancellor of Research, Mashhad university of Medical Sciences, Mashhad University of Medical Sciences ,University Avenue.Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)