The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc in Men With Idiopathic Asthenozoospermia
- Conditions
- Men Infertility
- Interventions
- Registration Number
- NCT05178953
- Lead Sponsor
- Arak University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 160
- infertile men
- have had at least one year of unprotected intercourse infertility
- asthenozoospermia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zinc Sulfate group Zinc Sulfate 220 mg Capsules Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. Candidates receive one zinc sulfate tablet(229 mg) daily for 3 month,(Zinc Sulfate 220mg Capsules) Other Names: zinc sulfate pentoxifylline group Pentoxifylline Group 1: Patients receiving pentoxifylline (TRENTAL 400 mg tablets, OSPS; 400 mg, twice daily) Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. These volunteers receive two pentoxifylline tablets(400 mg) daily for 3 month, (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily) Other names: Trental pentoxifylline+ zinc group Zinc Sulfate 220 mg Capsules Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. Candidates receive one zinc sulfate(220mg) tablet+ two pentoxifylline tablets(400 mg) daily for 3 month (TRENTAL 400 mg modified release tablets, OSPS; 400 mg +Zinc Sulfate 220mg Capsules) Other Names: zinc sulfate pentoxifylline+ zinc group Pentoxifylline Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. Candidates receive one zinc sulfate(220mg) tablet+ two pentoxifylline tablets(400 mg) daily for 3 month (TRENTAL 400 mg modified release tablets, OSPS; 400 mg +Zinc Sulfate 220mg Capsules) Other Names: zinc sulfate
- Primary Outcome Measures
Name Time Method lipid proxidation One week Malondialdehyde (nmol/mL), is measured using related experimental kits
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
reactive oxygen species One week eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits
FSH hormon One week FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit
sperm morphology 1 day Calculate the percentage of sperm with a normal shape with the help of Papanic staining
total antioxidant capacity One week total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits
LH hormon One week LH (IU / L) is measured from the blood serum of volunteers using ELISA kit
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 DNA Fragmentation Assay(SDFA) One week DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
- Secondary Outcome Measures
Name Time Method BAX expression 3 month BAX expression \[ Time Frame: 3 months \]
expression of BAX gen(in p.c) using real-time PCR and Western blotcaspase 3 expression 3 months expression of caspase 3 gen(in p.c) using real-time PCR and Western blot
Bcl2 expression 3 months Bcl-2 gen(in p.c) using real-time PCR and Western blot
Trial Locations
- Locations (2)
Arak university of medical science
🇮🇷Arak, Markazi, Iran, Islamic Republic of
Infertility Center
🇮🇷Arak, Markazi, Iran, Islamic Republic of