Alpha Lipoic Acid Plus Coenzyme Q10 Versus Coenzyme Q10 Alone in Asthenozoospermia

Overview

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.

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 12 Group B. Group A will receive Alpha-lipoic acid 500mg plus CoenzymeQ10 200mg per day and Group B will receive CoenzymeQ10 200mg alone for 12 weeks. They will be informed not to take other medications that could affect spermatogenesis during the study period; like Testosterone, Methotrexate, Tricyclice Anti-Depressant Selective Seretonin Receptor Inhibitor, Nifedipine, Diltiazem, Tamsulosin, Phenytoin, Na valproate etc. Then pre-treatment and post-treatment semen parameters, including sperm motility, sperm concentration and sperm morphology will be assessed. The total motile sperm count (ejaculate volume X sperm concentration X motile fraction) will be calculated. 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 will be performed.