Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Measure the change in semen parameters after 26 Weeks of coenzyme q10.
研究概览
简要总结
To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility
详细描述
Decreased serum CoQ10 concentrations as well as a decrease in the CoQ10H2 to-ubiquinone ratio have been demonstrated in diseases associated with OS. A strong correlation among sperm count, motility and ubiquinol-10 levels in seminal fluid has also been reported.
The aim of the present study is to investigate whether the effects of the exogenous administration of ubiquinol in the improvement of semen parameters in Pakistani men population.
Patients who full filled the inclusion criteria and gave informed written consent will be included in the trial. Patient will start to take medication and will take it for 26 weeks.
All men undergo a thorough physical examination, a detail history, serum biochemical and hematological laboratory tests and measurement of serum sex and thyroid hormone levels. A questionnaire will be used to collect information on demographic characteristics. Two semen samples 1 and 2 month apart will be obtained after 3 to 5 days of sexual abstinence and process within 1 hour of ejaculation. The mean of the two will be used for statistical analysis. Semen analyses will be performed using WHO recommended methods.
3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •To sign the Informed Consent form
- •Patients will be recruited in the study if they will fulfilled the criteria of history of primary infertility of more than 2 years, abnormal sperm count and motility
- •age between 20 and 50 years
- •No known medical or surgical condition which can result in infertility
排除标准
- •Voluntary withdrawal
- •Poor compliance of visit/treatment
- •A history of cancer chemotherapy or radiotherapy
- •A history of genital disease such as cryptorchidism and varicocele; a history of genital surgery
- •Body mass index 30 kg/m or greater; any endocrinopathy
- •Ychromosome microdeletions or karyotype abnormalities
- •leukocytospermia
- •Drug or substance abuse; tobacco use;
- •Use of anticonvulsants, androgens or antiandrogens
- •Significant liver (serum bilirubin greater than 2.0 mg/dl)
- •Renal function (serum creatinine greater than 2.0 mg/dl) impairment
- •Patients with severe oligozoospermia (less than 5 X 106/ml), azoospermia and testicular volume less than 12 ml will also excluded from study.
研究组 & 干预措施
coenzyme Q10
Dose of 200 mg of CoQ10 taken daily by mouth from day 1 till 26 weeks
干预措施: Coenzyme Q10 (Drug)
结局指标
主要结局
Measure the change in semen parameters after 26 Weeks of coenzyme q10.
时间窗: 26 weeks
To measure the change in semen parameters after 26 Weeks of coenzyme q10. Designated as safety issue: No
次要结局
- Adverse Event(26 weeks)