The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc on Semen Parameters, Reproductive Hormones, DNA Fragmentation, and Some Biochemical, and Inflammatory Parameters in Men With Idiopathic Infertility
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- lipid proxidation
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 23 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •infertile men
- •have had at least one year of unprotected intercourse infertility
- •asthenozoospermia
排除标准
- •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
研究组 & 干预措施
pentoxifylline group
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
干预措施: Pentoxifylline (Drug)
Zinc Sulfate group
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
干预措施: Zinc Sulfate 220 mg Capsules (Drug)
pentoxifylline+ zinc group
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
干预措施: Zinc Sulfate 220 mg Capsules (Drug)
pentoxifylline+ zinc group
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
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
lipid proxidation
时间窗: One week
Malondialdehyde (nmol/mL), is measured using related experimental kits
sperm concentration
时间窗: 1 day
count of sperm(In per million - with the help of a neobar slide and microscopic observation
spem motility
时间窗: 1 day
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
reactive oxygen species
时间窗: One week
eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits
FSH hormon
时间窗: One week
FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit
sperm morphology
时间窗: 1 day
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
total antioxidant capacity
时间窗: One week
total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits
LH hormon
时间窗: 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
时间窗: One week
testosterone (nanomolar per liter) is measured from the blood serum of volunteers using ELISA kit
(Tissue necrosis Factor)
时间窗: One week
TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit
interleukin-6
时间窗: One week
interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit
Sperm DNA Fragmentation Assay(SDFA)
时间窗: One week
DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
次要结局
- BAX expression(3 month)
- caspase 3 expression(3 months)
- Bcl2 expression(3 months)
研究者
Zeynab
Principal Investigator
Arak University of Medical Sciences