Men Infertility
Conditions
Brief summary
The aim of this study was to investigate the therapeutic effect of co-administration of pentoxifylline and zinc on sperm apoptosis in men with idiopathic infertility
Detailed description
This study is being performed as a double-blind randomized clinical trial on idiopathic infertile men referred to the infertility clinic of Shafa 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. Any medication that may affect the course of spermatogenesis should be discontinued during the study. Semen samples are taken from patients (before and after interventions) and apoptosis tests are performed on semen samples.
Interventions
DRUGZinc Sulfate 220 mg Capsules
Zinc is an element that is involved in the activity of antioxidant enzymes. For example, the superoxide dismutase needs copper and zinc to function properly. Infertile men with asthenospermia receive 220 mg zinc sulfate tablets for 3 months
DRUGPentoxifylline
Oral use of pentoxifylline is effective in treating cardiovascular disease, cerebrovascular disease, and other conditions associated with local circulatory disorders. Pentoxifylline affects blood viscosity. Infertile men with asthenospermia receive 400 mg pentoxifylline tablets for 3 months
Sponsors
Arak University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
23 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* infertile men * have had at least one year of unprotected intercourse infertility * asthenozoospermia
Exclusion criteria
* Men with varicocele * Hypersensitivity to pentoxifylline & zinc, * pelvic organic pathologies * congenital adrenal hyperplasia * thyroid dysfunction * Cushing's syndrome * hyper prolactinemia * androgen secreting neoplasia * severe hepatic * pancreatitis * kidney diseases * gallbladder diseases * Patients with alcohol consumption * Patients who use cigarettes and drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm DNA Fragmentation Assay(SDFA) | One week | DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm). |
| testosteron hormon [ Time Frame: One week after starting the medication ] testosterone | One week | testosterone (nanomolar per liter) is measured from the blood serum of volunteers using ELISA kit |
| (Tissue necrosis Factor) | One week | TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit |
| interleukin-6 | One week | interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit |
| sperm concentration | 1 day | count of sperm(In per million - with the help of a neobar slide and microscopic observation |
| spem motility | 1 day | motility of sperm: Calculate the percentage of motile sperm using microscopic observation |
| sperm morphology | 1 day | Calculate the percentage of sperm with a normal shape with the help of Papanic staining |
| lipid proxidation | One week | Malondialdehyde (nmol/mL), is measured using related experimental kits |
| reactive oxygen species | One week | eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits |
| total antioxidant capacity | One week | total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits |
| FSH hormon | One week | FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit |
| LH hormon | One week | LH (IU / L) is measured from the blood serum of volunteers using ELISA kit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bcl2 expression | 3 months | Bcl-2 gen(in p.c) using real-time PCR and Western blot |
| caspase 3 expression | 3 months | expression of caspase 3 gen(in p.c) using real-time PCR and Western blot |
| BAX expression | 3 month | BAX expression \[ Time Frame: 3 months \] expression of BAX gen(in p.c) using real-time PCR and Western blot |
Countries
Iran
Contacts
Primary Contactzeynab dadgar, dr
Backup Contacthamzeh amiri, dr
Outcome results
None listed