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

The effect of vitamin D supplementation on spermatogram, seminal and serum levels of oxidative stress indices in idiopathic oligoasthenospermia infertile men

Clinical controlled trial, with parallel groups, triple blind and randomized

Present study is a triple blind randomized controlled clinical trials that will be done on idiopathic oligoasthenospermia infertile patients with deficient or insufficient levels of vitamin D referring to the urologist in Jahad daneshgahi Infertility Center in Ahvaz.

Inclusion criteria: willing to participate in the study and filling out the informed consent form; no conception after 12 months intercourse without any contraception); 20-49 y.o.; idiopathic oligoasthenozoospermia according to WHO criteria; vitamin D levels ≤ 30 ng, ml; Normal hormonal profile. Exclusion criteria: any known causes of infertility; any chronic disease and 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.

Patients in the intervention group will receive vitamin D tablet at a dose of 4,000 units per day for 12 weeks. Patients in the placebo group, will receive placebo tablets which is apparently similar to vitamin D, but contains maltodextrin.

Serum and seminal Total antioxidant capacity (TAC) and Malondialdehyde (MDA); seminal fluid 8-Hydroxy Deoxy guanosine concentration (8-OHDG); seminal fluid calcium and spermatozoa intracellular calcium; serum Levels of vitamin D (25 hydroxyvitamin D), calcium, phosphorus and parathormone

Changing the sampeling completion date. Due to the lack of timely completion of the intervention because of the coronavirus prevalence sampeling was delayed.

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.

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.