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IRCT20151128025274N4 IRCT 2018-03-28 Ahvaz University of Medical Sciences The effect of vitamin D supplementation on male infertility The effect of vitamin D supplementation on spermatogram, seminal and serum levels of oxidative stress indices in idiopathic oligoasthenospermia infertile men: triple blind clinical trial 2018-04-29 anticipated 86 Complete https://irct.ir/trial/29983 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients in each of the study groups (supplements or placebo) will be done by statistical software using classified randomized blocking method (4 blocks) based on age ( 20 to 40 and 40 to 49) and sperm concentration ( 5-15 and 15-20 million per milliliter). In addition, in order to reduction selection bias error, allocation concealment will be used. This will be done by assigning unit codes to each person's drugs, Blinding description: In order to reduction selection bias error, allocation concealment method will be used.This will be done by assigning unit codes to each person's drugs. In this way, the participants, the researcher and the statistical analyst, will be kept blind to assignment of the study groups. N/A Male Infertility. Intervention 1: Intervention group: Patients in the intervention group will receive vitamin D supplementation (in tablet form) at a dose of 4,000 units per day for 12 weeks. Vitamin D supplementation will be provided by Ahvaz Jundishapur Pharmaceutical Technology Development Center. Intervention 2: Control group: Patients in the control group will receive placebo (in tablet form) per day for 12 weeks. Placebo tab is apparently similar to the vitamin D supplement, but containing maltodextrin. The placebo will be provided by the Ahvaz Jundishapur Pharmaceutical Technology Development Center. 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 am not sure that I have permission to share the data.
public Leila Maghsoumi-Norouzabad
Golestan Highway, Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 6135715751 +98 61 3373 8330 l.maghsumi55@gmail.com Ahvaz University of Medical Sciences scientific Ahmad Zare Javid
Golestan Highway, Ahvaz Jundishapur University of Medical Sciences
Ahvaz Iran (Islamic Republic of) 6135715751 +98 61 1373 8330 ahmaddjavid@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Willing to participate in the study and filling out the informed consent form They should be infertile (no conception after 12 months intercourse without any contraception) Age 20-49 y.o. Idiopathic oligoasthenozoospermia according to WHO criteria Vitamin D levels ≤ 30 ng, ml Normal hormonal profile 20 years 49 years Male Any known causes of infertility (such as infection in genitourinary (GU) tract, anatomical abnormality in GU tract, immunological and etc.) Any chronic disease and any surgery in GU tract Any antioxidant supplements consumption, drug treatment or alcohol consumption during last 3 months Candidate for ICSI (sperm injection inside the cytoplasm) Contact with pesticides, heavy metals and solvents Severe physical activity and body mass index (BMI) higher than 30 and less than 18.5 kg,m2 N46 Male infertility Treatment - Drugs Placebo Intervention group: Patients in the intervention group will receive vitamin D supplementation (in tablet form) at a dose of 4,000 units per day for 12 weeks. Vitamin D supplementation will be provided by Ahvaz Jundishapur Pharmaceutical Technology Development Center. Control group: Patients in the control group will receive placebo (in tablet form) per day for 12 weeks. Placebo tab is apparently similar to the vitamin D supplement, but containing maltodextrin. The placebo will be provided by the Ahvaz Jundishapur Pharmaceutical Technology Development Center. Total sperm count. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Spermatogram. Sperm Motility. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Spermatogram. Serum and seminal Total Antioxidant Capacity. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: ELISA. Serum and seminal Malondialdehyde. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: ELISA. Seminal 8-hydroxy Deoxy guanosine. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: ELISA. Serum 25 hydroxyvitamin D. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: ELISA. Serum and seminal calcium. Timepoint: Before the start of the intervention and 12 weeks after the intervention. Method of measurement: Calorimetry. Serum phosphate. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: Calorimetry. Spermatozoa intracellular calcium. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: ELISA. Serum Parathormon. Timepoint: Before intervention and 12 weeks after the intervention. Method of measurement: ELISA. Ahvaz University of Medical Sciences Approved 2018-02-23 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Golestan Highway, Deputy of Research and Technology; Ahvaz Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)