Kocaeli University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- sperm motility (%)
研究概览
简要总结
Infertility is defined as the inability to become pregnant despite 12 months of regular and unprotected intercourse. Male factors include defects in sperm concentration, morphology and motility, among which low sperm motility (asthenozoospermia) is one of the most common types of male infertility and affects approximately 40% of all cases.
It has become clear that protein defects in spermatozoa and semen can cause fertilization failure by affecting sperm motility, and it is necessary to define proteins and related pathways precisely because they have an important role in the treatment phase.
Increasing evidence shows that free oxygen radicals that occur as a result of oxidative stress (OS) play a very important role in the etiology of male infertility.
A systematic review including 29 studies (19 randomized clinical trials and 10 prospective studies) examined the effect of antioxidant food supplementation and reported a positive effect on baseline semen parameters, advanced sperm function, outcomes of assisted reproductive therapy, and live birth rate.
Conversely, few studies have failed to confirm any positive effect of antioxidant therapy and even report a negative effect on male fertility. Therefore, there is no clear consensus on the clinical efficacy of antioxidant therapy yet.
Since the pathogenesis has not yet been clearly demonstrated, treatments are not based on evidence, but based on clinical experience.
Our aim was to randomly divide infertile male patients who applied to our clinic with the complaint of infertility and found asthenozoospermia (restricted sperm motility) in their semen analysis into two arms and examine the effects of antioxidant food supplementation on sperm motility and proteomic structure with a placebo-comparative, prospective, double-blind study (LC-MS/MS). analysis) is to reveal the metabolic pathways that may lead to restriction of movement. The effect of antioxidant food support on sperm parameters and free oxygen radical levels in the control spermiogram after 3 (three) months of treatment to be given to the patients will be measured by ELISA method and compared with pre-treatment values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Being in the age range of 20-40
- •Be infertile ( 12 months intercourse without any contraception)
- •Due to infertility, you should apply to us and have a spermiogram detection of asthenozoospermia
- •Patients whose spouses have normal gynecological examinations
- •Patients with normal physical examinations
- •Patients with normal hormonal values (FSH, LH,PRL,Testosterone,Estrogen) -
排除标准
- •previous treatment for infertility
- •Previously due to infertility or for any reason take antioxidant food supplements
- •Surgery or physical examination due to varicocele detection of varicocele
- •Detection of endocrine disorder (Defect in serum blends)
- •Smokers and alcohol addiction
- •Detection of infection in the genital tract
- •Having a chronic illness -
研究组 & 干预措施
A
The treated group
干预措施: Proxeed Plus 2*1 A arm (Biological)
B
The placebo group
干预措施: Placebo (Biological)
结局指标
主要结局
sperm motility (%)
时间窗: 12 weeks
semen analysis (microscopic analysis)
次要结局
- Proteomics analysis(8 weeks)
- oxidative stress(4 weeks)