AsthenozoospermiaCoQ10 ALANCT07455890
Alpha Lipoic Acid Plus Coenzyme Q10 Versus Coenzyme Q10 Alone in Asthenozoospermia
A study testing ALA 500mg once daily for 3 month and CoenzymeQ10 in people with Asthenozoospermia, run by Mst.Sumyara Khatun at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Asthenozoospermia
- What is being tested?
- ALA 500mg once daily for 3 month and CoenzymeQ10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
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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Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthenozoospermia
- Being tested
- ALA 500mg once daily for 3 month, CoenzymeQ10
- Keywords
- asthenozoospermia, Alpha-lipoic acid, coenzymeQ10
- Medical subject headings
- Asthenozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALA 500mg once daily for 3 monthCombination product
participants will receive ALA 500mg plus CoQ10 100mg twice daily for 3 months
CoenzymeQ10Dietary supplement
CoenzymeQ10 100mg twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental (ALA+ CoQ10) | Experimental | ALA 500mg plus CoQ10 100mg twice daily for 3 month Receives: Combination Product: ALA 500mg once daily for 3 month; Dietary Supplement: CoenzymeQ10 |
| Comparator arm | Active comparator | CoenzymeQ10 100mg twice daily for 3 month Receives: Dietary Supplement: CoenzymeQ10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sperm motility
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.
Measured: Baseline(pre treatment) and 12 weeks after start of treatment
Secondary outcomes (1)
Progressive sperm motility
Percentage of sperm showing progressive motility
Measured: Baseline(pre treatment) and 12 weeks after start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jul 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthenozoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label parralel design randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mst.Sumyara Khatun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mst.Sumyara Khatun, Bangladesh Medical University
- Investigators
- Jemine Banu, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455890
- Sponsor's protocol ID
- 5141
- Acronym
- CoQ10 ALA
- Status last verified
- Jul 2024
- First submitted
- 3 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hodeeb YM, El-Rewiny EM, Gaafar AM, Zayed AN, Hasan MS, Elsaie ML. The effect of alpha lipoic acid supplementation on sperm functions in idiopathic asthenozoospermic patients: a case-controlled study. Hum Fertil (Camb). 2023 Dec;26(5):949-957. doi: 10.1080/14647273.2021.2025271. Epub 2022 Jan 13.
PubMed 35023797Haghighian HK, Haidari F, Mohammadi-Asl J, Dadfar M. Randomized, triple-blind, placebo-controlled clinical trial examining the effects of alpha-lipoic acid supplement on the spermatogram and seminal oxidative stress in infertile men. Fertil Steril. 2015 Aug;104(2):318-24. doi: 10.1016/j.fertnstert.2015.05.014. Epub 2015 Jun 11.
PubMed 26051095
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alpha-lipoic Acid Plus CoenzymeQ10 in Comparison With CoenzymeQ10 Alone on Sperm Motility in Idiopathic Asthenozoospermia
- ClinicalTrials.gov ID
- NCT07455890
- Acronym / sponsor ID
- CoQ10 ALA / 5141
- Conditions
- Asthenozoospermia
- Keywords
- asthenozoospermia, Alpha-lipoic acid, coenzymeQ10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mst.Sumyara KhatunUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label parralel design randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental (ALA+ CoQ10) | Experimental | Combination Product: ALA 500mg once daily for 3 month, Dietary Supplement: CoenzymeQ10ALA 500mg plus CoQ10 100mg twice daily for 3 month |
| Comparator arm | Active comparator | Dietary Supplement: CoenzymeQ10CoenzymeQ10 100mg twice daily for 3 month |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALA 500mg once daily for 3 monthparticipants will receive ALA 500mg plus CoQ10 100mg twice daily for 3 months | Combination product | Experimental (ALA+ CoQ10) |
| CoenzymeQ10CoenzymeQ10 100mg twice daily for 3 months | Dietary supplement | Comparator arm, Experimental (ALA+ CoQ10) |
Primary outcome
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.
1 secondary outcome
Progressive sperm motility
Time frame: Baseline(pre treatment) and 12 weeks after start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Results publication: PubMed 35023797Hodeeb YM, El-Rewiny EM, Gaafar AM, Zayed AN, Hasan MS, Elsaie ML. The effect of alpha lipoic acid supplementation on sperm functions in idiopathic asthenozoospermic patients: a case-controlled study. Hum Fertil (Camb). 2023 Dec;26(5):949-957. doi: 10.1080/14647273.2021.2025271. Epub 2022 Jan 13.
- Results publication: PubMed 26051095Haghighian HK, Haidari F, Mohammadi-Asl J, Dadfar M. Randomized, triple-blind, placebo-controlled clinical trial examining the effects of alpha-lipoic acid supplement on the spermatogram and seminal oxidative stress in infertile men. Fertil Steril. 2015 Aug;104(2):318-24. doi: 10.1016/j.fertnstert.2015.05.014. Epub 2015 Jun 11.
- Individual participant dataSharing planned: No
Related trials for Asthenozoospermia
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Oligozoospermia and/or Asthenozoospermia
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
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PKB171 Against Placebo in Couples With Mild Male Factor Infertility
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Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jemine Banu study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALA 500mg once daily for 3 month and CoenzymeQ10 in people with Asthenozoospermia, run by Mst.Sumyara Khatun at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sperm motility (time frame: Baseline(pre treatment) and 12 weeks after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07455890, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.