Effects of Alpha-lipoic Acid Plus CoenzymeQ10 in Comparison With CoenzymeQ10 Alone on Sperm Motility in Idiopathic Asthenozoospermia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total sperm motility
研究概览
简要总结
The goal of the clinical trial is to learn if Alpha-lipoic acid plus Coenzymeq10 work to treat asthenozoospermia in subfertile male. It will also learn about the safety of drug Alpha-lipoic acid plus Coenzymeq10. The main queations it aim to answer are: Does drug Alpha-lipoic acid plus CoenzymeQ10 increase sperm motility in participents? What medical problems do participants have when taking Alpha-lipoic acid plus Coenzymeq10? Reseachers will compare drug Alpha-lipoic acid plus Coenzymeq10 combination to Coenzymeq10 alone to see if alpha-lipoic acid plus Coenzymeq10 combination drugs work better. Participants will experimental group: Alpha-lipoic acid 500mg once daily plus coenzymeq10 100mg twice daily for 3 months. Comparator group: CoenzymeQ10 100mg twice daily for 3 months. visit the clinic after 3 monyhs of treatment for check up and tests.
详细描述
This study will be conducted in the Department of Reproductive Endocrinology & Infertility, BSMMU. Ethical clearance will be obtained from the Institutional Review Board. The study population will be the infertile men with abnormal semen parameters according to WHO Laboratory manual 6 th Edition in 2021, fulfilling the inclusion and exclusion criteria.
A baseline semen analysis for the evaluation of male subfertility will be done. The study population will be the diagnosed case of male subfertility with asthenozoospermia. Subfertility will be determined by clinical history. Asthenozoospermia will be determined by semen analysis (WHO criteria 2021). A baseline semen sample will be collected in the laboratory of Reproductive Endocrinology & Infertility, BSMMU by masturbation in a sterile plastic container.
The sperm parameter will be checked by Makler Counting Chamber. An aliquot (0.5 ml) of each well-mixed semen sample will be placed on the Makler counting chamber, and the coverslip will be applied. The spermatozoa will be allowed to sediment for 3 minutes. Recognizable spermatozoa will be counted in 10 squares with x20 objective of a light microscope and recorded as spermatozoa in millions/mL of semen.
Those with abnormal semen parameters will have a thorough physical examination and routine laboratory screening. Blood will be taken for baseline hormone measurements of total testosterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), Thyroid stimulating hormone (TSH) & Prolactin, FBS, 2HA 75gm at Department of Biochemistry and Molecular Biology, BSMMU. The eligibility for the trial will be decided with inclusion and exclusion criteria. The eligible participants will be briefed in detail regarding the objective, rationality and potential benefits of the study. The patients will be counselled regarding the drugs and unexpected side effects and informed written consent will be taken. Participants will be informed that they can withdraw from the study wherever they want without any consequences. All the data will be noted in the clinical record form.
A total of 50 patients will be included in the study according to the inclusion and exclusion criteria. Eligible men will be randomly allocated into either Group A or
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
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 20-45 years. Subfertile males with asthenozoospermia
- •Severe oligoasthenoteratozoospermia Endocrinopathies Patients who have additional factors of infertility such as varicocele or ejaculatory duct obstruction. History of chemotherapy or radiotherapy, genital infection, genital surgery. Any medical and endocrine disorders like hypertension, diabetes mellitus, hypothyroidism , hyperprolactinemia, renal. Antioxidants supplmentation in the last three months Drug, alcohol or substance abuse, psycho-sexual abnormalities.
排除标准
- 未提供
研究组 & 干预措施
Experimental (ALA+ CoQ10)
ALA 500mg plus CoQ10 100mg twice daily for 3 month
干预措施: ALA 500mg once daily for 3 month (Combination Product)
Experimental (ALA+ CoQ10)
ALA 500mg plus CoQ10 100mg twice daily for 3 month
干预措施: CoenzymeQ10 (Dietary Supplement)
Comparator arm
CoenzymeQ10 100mg twice daily for 3 month
干预措施: CoenzymeQ10 (Dietary Supplement)
结局指标
主要结局
Total sperm motility
时间窗: Baseline(pre treatment) and 12 weeks after start of treatment
Percentage of sperm showing progressive motility on microscopic examination, measured using WHo manual standards, after 30-60 minutes liquifaction, at 37 degree celcius, averaged over two independent readings by trained laboratory technicians blinded to treatment allocation.
次要结局
- Progressive sperm motility(Baseline(pre treatment) and 12 weeks after start)
研究者
Mst.Sumyara Khatun
Medical Officer
Bangladesh Medical University