Alpha Lipoic Acid Plus Coenzyme Q10 Versus Coenzyme Q10 Alone in Asthenozoospermia (CoQ10 ALA)

March 3, 2026 updated by: Mst.Sumyara Khatun

Effects of Alpha-lipoic Acid Plus CoenzymeQ10 in Comparison With CoenzymeQ10 Alone on Sperm Motility in Idiopathic Asthenozoospermia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Shahbag
      • Dhaka, Shahbag, Bangladesh, 1000
        • Bangladesh Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental (ALA+ CoQ10)
ALA 500mg plus CoQ10 100mg twice daily for 3 month
Combination product: ALA 500mg once daily for 3 month
participants will receive ALA 500mg plus CoQ10 100mg twice daily for 3 months
Dietary supplement: CoenzymeQ10
CoenzymeQ10 100mg twice daily for 3 months
Active Comparator: Comparator arm
CoenzymeQ10 100mg twice daily for 3 month
Dietary supplement: CoenzymeQ10
CoenzymeQ10 100mg twice daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sperm motility
Time Frame: 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.
Baseline(pre treatment) and 12 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progressive sperm motility
Time Frame: Baseline(pre treatment) and 12 weeks after start
Percentage of sperm showing progressive motility
Baseline(pre treatment) and 12 weeks after start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mst.Sumyara Khatun

Investigators

  • Study Director: Jemine Banu, Bangladesh Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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