The aim of this study is to investigate the impact of co-administration of Pentoxifylline and Zinc sulfate on oxidative stress, apoptosis, and inflammation, sperm capacitation and parameters in infertile men.
This study will be performed as a double-blind randomized clinical trial on idiopathic infertile men (including oligoasthenosospermia, dyspnea, astheno-teratozoospermia, oligo-astheno-teratozoospermia) referred to Shafa Infertility Clinic. Patient satisfaction, non-use of contraceptives, men aged 25 to 43 years and idiopathic infertility according to WHO criteria (World Health, 2010) are our study criteria. A food questionnaire is also taken from them to identify patients. Any medication that may affect sperm production should be discontinued within three months of the study. Sampling and administration of pentoxifylline and zinc: Preparation and analysis of semen samples are performed according to WHO 2010 recommendations. Semen samples are prepared by masturbating after a 3 to 5 day abstinence period. Two semen samples from these men, one before and the other after the intervention, are evaluated for basic parameters. For liquefaction, semen samples are incubated for 30 to 60 minutes at 37 ° C. Microscopic tests are performed to evaluate indicators such as sperm concentration in semen, motility and sperm morphology. Objectives and study methods are explained to patients who meet the inclusion criteria. Written consent is then obtained from the candidate. Body mass index (BMI) is assessed for patients. Also, at the beginning of the study, 5 cc of blood is taken from patients to measure reproductive hormones.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive two placebo tablets daily
Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive two trental tablets daily
count of sperm
count of sperm(In per million - with the help of a neobar slide and microscopic observation
Time frame: One week after starting the medication
motility of sperm
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
Time frame: One week after starting the medication
morphology of sperm
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
Time frame: One week after starting the medication
Malon di aldehyd evaluate
Malondialdehyde (nmol/mL), will be measured using related experimental kits
Time frame: One week after starting the medication
ROS evaluate
reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits
Time frame: One week after starting the medication
TAC (Total Antioxidant Capacity) evaluate
total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits
Time frame: One week after starting the medication
FSH hormon
FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
Time frame: One week after starting the medication
LH hormon
LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
Time frame: One week after starting the medication
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Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive one zinc sulfate tablet daily
Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive two pentoxifylline tablets+ one zinc tablet daily
Testosteron hormon
testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit
Time frame: One week after starting the medication
TNF α( Tissue necrosis Factor)
TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit
Time frame: One week after starting the medication
Interleukin-6 (IL-6)
Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit
Time frame: One week after starting the medication
Sperm DNA Fragmentation Assay(SDFA)
DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
Time frame: One week after starting the medication