Effect of DHEA Plus Coenzyme Q10 Combination Therapy Compared to Coenzyme Q10 Alone on Sperm Concentration in Subfertile Male With Oligospermia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Sperm concentration
研究概览
简要总结
The goal of the clinical trail is to learn weather DHEA plus Coenzyme Q10 works better to improve sperm concentration in subfertile male with oligospermia. We will also learn about the saftey of combination of drugs.
The main question it aims to answer are:
Does taking DHEA plus Coenzyme Q10 improve sperm concentration compared to Coenzyme Q10 alone? Are there any side effects or saftey concerns with DHEA plus Coenzyme Q10?
Researcher will compare DHEA plus Coenzyme Q10 with Coenzyme Q10 to see weather cobination drugs works better in improving sperm count than Coenzyme Q10 alone.
Participant will randomly placed into two group:
Group A (Combination Group): Tablet DHEA 25 mg BD and tablet Coenzyme Q10 100mg BD for 3 months.
Group B (Alone Group): Tablet Coenzyme Q10 100mg BD for 3 months. All participants will follow up at the start and after 3 months of treatment for check up and test.
详细描述
This Randomized controlled trial will be conducted in the Department of Reproductive Endocrinology & Infertility, BMU from the day of approval. Ethical clearance will be obtained from the Institutional Review Board. The study population will be the subfertile men with oligospermia 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 infertility will be done. Infertility will be determined by clinical history. A baseline semen sample will be collected in the laboratory of Reproductive Endocrinology & Infertility, BMU 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.
A total of 52 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 Group B. Group A will receive (DHEA 25mg and Coenzyme Q10 100mg) twice daily and Group B will receive (Coenzyme Q10 100mg) twice daily for 3 months. They will be informed not to take other medications that could affect spermatogenesis during the study period expect after counseling physician.
The side effects and the spontaneous pregnancies will also be recorded. There will be two hospital visits during the dosing period. During the initial visit after recruitment, the participants will be prescribed medicines by some designated prescribing form.
One week later, a telephone interview will be conducted to review for side effects and arrange an early appointment at the patient's request if needed. Patients will be advised for timed sexual intercourse and for urinary pregnancy test in case of missed period. After three months of intervention, a semen analysis and serum testosterone level will be performed.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 20-50 years. Subfertile males with oligospermia (sperm concentration less than16 million/ml)
排除标准
- •Severe oligospermia (less than 5million/ml) Any medical and endocrine disorders like hypertension, diabetes mellitus, hypothyroidism, hyperprolactinemia, renal or liver disease. Any abnormality on genital examination and scrotal sonogram. History of chemotherapy or radiotherapy, genital infection, genital surgery. Antioxidants supplmentation in the last 3 months Drug, alcohol or substance abuse, psycho-sexual abnormalities.
结局指标
主要结局
Sperm concentration
时间窗: 3 months
The number of sperm cells present in one milliliter of semen, measured by microscopic semen analysis according to WHO standards, after 30-60 min of liquifaction, at 37 degree celcius, avereged over two independent reading byt trained laboratory technicians blinded to tratmentt allocation.
次要结局
未报告次要终点
研究者
Mst.Sumyara Khatun
Medical Officer
Bangladesh Medical University