Evaluation of the effects of Propolis Supplementation on Semen Parameters, Oxidative Stress Biomarkers, Sperm DNA Fragmentation and the Expression of Long Non-Coding RNA HOTAIR in Infertile Men with Asthenozoospermia

Determining the effects of propolis supplementation on sperm parameters, oxidative stress , sperm DNA fragmentation and HOTAIR LncRNA expression in infertile men with asthenozoospermia.

Clinical trial with control group, parallel, double-blind, randomized block method on 60 patients.

Patients referring to the infertility clinic of Imam Khomeini Hospital in Ahvaz, after being diagnosed by a specialist doctor, will be included in the study if they have informed consent and meet the inclusion criteria. Patients are randomly divided into two groups receiving propolis and placebo. Participants and evaluators and researchers do not know which group they are in

Inclusion criteria; Willingness to participate in the study At least one year passed since the decision to have children and not using contraceptives Age 20 to 50 years suffering from asthenozoospermia with total sperm motility less than 40% in the semen sample of unknown origin. Exclusion criteria; The presence of a known cause of infertility (hormonal disorders, epididymal duct obstruction and epididymovarcitis), Drug abuse ,Alcohol use Having a chronic disease (diabetes, kidney disease, chronic liver disease), Varicocele, Infectious diseases characterized by fever and leukocytosis. body mass index (BMI) higher than 30 and less than 18.5 kg/m2

Patients are randomly divided into two groups(propolis or placebo). The propolis group will be given propolis capsules (500 mg 3 times a day) and the placebo group will be given placebo capsules.

Semen parameters, oxidative stress , sperm DNA fragmentation and (HOX antisense intergenic RNA) LncRNA ( (HOTAIR)expression

In this study, the permutation block randomization method will be used. In this two-group clinical trial, the size of the blocks will be considered randomly, 4, 6, and 8 (in this method, the number of people assigned to each group is equal in each of the blocks). The randomization tool is R software, which is used to generate random sequences. For concealment, we use random allocation concealment. This method is used to perform a random sequence on the study participants. In such a way that the assigned group is not known before assigning a person. This method is performed using opaque sealed envelopes with random sequence.

Placebo and propolis supplement both have the same size capsules with similar colors. The volume and weight filled in both capsules are equal to each other. Propolis and placebo supplements are packaged in identical packages with the coding of drug A and drug B. The person responsible for the packaging of propolis supplements and placebo will determine the type of supplement or placebo without knowing the content by providing the code, which has no role in the implementation and analysis of the study data. In this study, the moderators (including student, supervisors and consultants) as well as patients will be unaware of the type of supplement received by each patient.