AsthenozoospermiaNCT07252518
Effect of Pentoxifylline + CoQ10 vs CoQ10 Alone on Sperm Motility in Subfertile Men With Asthenozoospermia
A study testing Coenzyme Q 10 and Pentoxifylline 400 MG Oral Tablet in people with Asthenozoospermia, run by Mst.Sumyara Khatun at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to learn if drug Pentoxifylline plus Coenzyme Q10 work to treat asthenozoospermia in subfertile male. It will also learn about the safety of drug Pentoxifylline plus Coenzyme Q10. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Asthenozoospermia
- What is being tested?
- Coenzyme Q 10 and Pentoxifylline 400 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Oct 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Sub fertile men with asthenozoospermia(Total motility20% to less than 42%) according to WHO semen analysis,2021.
- Age 20-50 years.
Who cannot join
- Severe oligoasthenoteratozoospermia
- Any medical, endocrine and genetic disorders, history of chemotherapy or radiotherapy, genital infection, genital surgery.
- Antioxidants supplmentation in the last 3 months
- Drug, alcohol or substance abuse, psycho-sexual abnormalities.
- Any known hypersensitivity to xanthine related product, recent cerebral or retinal haemorrhage Severe oligoasthenoteratozoospermia
- Any medical, endocrine and genetic disorders, history of chemotherapy or radiotherapy, genital infection, genital surgery.
Show all 9Show fewer
- Antioxidants supplmentation in the last 3 months
- Drug, alcohol or substance abuse, psycho-sexual abnormalities.
- Any known hypersensitivity to xanthine related product, recent cerebral or retinal haemorrhage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh Medical University
Dhaka, Shahbag, 1000
Mst Sumyara Khatun Medical officer, MS, +8801746046581, sumirmc09@gmail.com
Kazi Jannatul ferdouse, +8801715595597, jannatulferdouse420@gmail.com
About this study
Official title: Effect of Pentoxifylline Plus Coenzyme Q10 Combination Therapy Compared to Coenzyme Q10 Alone on Sperm Motility in Sub-fertile Male With Asthenozoospermia
The goal of this clinical trial is to learn if drug Pentoxifylline plus Coenzyme Q10 work to treat asthenozoospermia in subfertile male. It will also learn about the safety of drug Pentoxifylline plus Coenzyme Q10. The main questions it aims to answer are:
Does drug Pentoxifylline plus Coenzyme Q10 increase the motility of sperm in participants? What medical problems do participants have when taking drug Pentoxifylline plus Coenzyme Q10 ? Researchers will compare drug Pentoxifylline plus Coenzyme Q10 combination to Coenzyme Q10 alone to see if drug Pentoxifylline plus Coenzyme Q10 combination works better.
Read more
Participants will:
Experimental Group:Pentoxifylline 400mg twice dailyand Coenzyme Q10 100mg twice daily for 3 months.
Comparator Group: Coenzyme Q10 100mg twice daily for 3 months Visit the clinic after three months of treatment for checkups and tests
Read the detailed description
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. A total 56 sub-fertile men with asthenozoospermia (Total motility 20% to <42%), according to WHO Laboratory manual 6th Edition in 2021, fulfilling the inclusion and exclusion criteria.will be approached for informed written consent after discussing the purpose and procedure of the study. Participants will be recruited from our OPD-2, room no-301 and referred outdoor room no-108, department of Reproductive Endocrinology \& Infertility.Baseline infertility investigations and semen analysis will be done. Detailed socio-demographic data, history, and investigations will be recorded in a predesigned data sheet. Eligible men who will give their informed consent will be randomized to either. Random sequence generation will be done by someone not involved in the study. Allocation concealment will be done by serially numbered closed opaque envelopes. Each envelope will be labeled with a serial number and will have a card noting the intervention type. Allocation will never be changed after opening the closed envelopes.At baseline, a minimum of two specimen will be collected at 4 weeks intervaland the second results showing asthenozoospermia will be considered as the baseline results.Semen sample will be collected after maintaining 3-5 days of abstinence, in the semen collection room no-110 of Reproductive Endocrinology \& Infertility, BMU by masturbation in a sterile plastic container. After getting the samples, they will be allowed to liquefy at 37 degrees Celsius and then will be analyzed according WHO,2021, in the laboratory of Reproductive Endocrinology \& Infertility department. 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. Motility evaluation will be performed within 3-5 minutes after application of the sample to avoid errors due to tendency of sperm to migrate from the periphery. All non-motile sperms will be counted within 9 or 16 squares. Then motile sperms will be counted in the same area and the grade of motility will be estimated from +1 to +4. This procedure will be repeated in another area of the grid,as well as from another 3-4 drops and the average will be calculated.
Experimental Group will receive (Pentoxifylline 400mg and Coenzyme Q10 100mg) twice daily and ComparatorGroup 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.
- Conditions
- Asthenozoospermia
- Being tested
- Coenzyme Q 10, Pentoxifylline 400 MG Oral Tablet
- Keywords
- Asthenozoospermia, Pentoxifylline, Coenzyme Q10
- Medical subject headings
- Asthenozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q 10Dietary supplement
Participants will receive Coenzyme Q10 100 mg twice daily for 3 months
Pentoxifylline 400 MG Oral TabletCombination product
Also called Coenzyme Q10
Participants will receive pentoxifylline 400mg twice daily plus coenzyme Q10 100mg twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental (PTX+ CoQ10) | Experimental | Participants receive pentoxifylline 400mg orally twice daily plus Coenzyme Q10 100mg twice daily orally Receives: Combination Product: Pentoxifylline 400 MG Oral Tablet |
| Active Comparator (Coenzyme Q10) | Active comparator | Participants receive Coenzyme Q10 100mg twice daily orally Receives: Dietary Supplement: Coenzyme Q 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive sperm motility
Percentage of sperm showing progressive motility (WHO catagories A+B) on microscopic examination,measured using WHO manual standards,after 30-60 minutes liquefaction, at 37 degree celcius, averaged over two independent readings by trained laboratory technicians blinded to treatment allocatiob
Measured: Baseline(pre treatment) and 12 weeks after start
Secondary outcomes (1)
Total sperm motility
Percentage of motile sperm (WHO catagories A+B+C) measured on fresh semen samples using WHO semen analysis method (latest edition) .Total motility is the percentage of sperm showing any motility (progressive and non progressive ) at the time of analysis.
Measured: Baseline (pre treatment) and 12 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Oct 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mst.Sumyara Khatun
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh Medical University
- Responsible party
- Sponsor-investigator, Mst.Sumyara Khatun, Bangladesh Medical University
- Investigators
- Jesmine Banu, MS, Principal investigator, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252518
- Sponsor's protocol ID
- 5721
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alahmar AT. The effects of oral antioxidants on the semen of men with idiopathic oligoasthenoteratozoospermia. Clin Exp Reprod Med. 2018 Jun;45(2):57-66. doi: 10.5653/cerm.2018.45.2.57. Epub 2018 Jun 29.
PubMed 29984205Barbonetti A, Tienforti D, Castellini C, Giulio FD, Muselli M, Pizzocaro A, Vena W, Baroni MG, Pivonello R, Isidori AM, Maggi M, Corona G. Effect of antioxidants on semen parameters in men with oligo-astheno-teratozoospermia: a network meta-analysis. Andrology. 2024 Mar;12(3):538-552. doi: 10.1111/andr.13498. Epub 2023 Jul 26.
PubMed 37495550
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pentoxifylline Plus Coenzyme Q10 Combination Therapy Compared to Coenzyme Q10 Alone on Sperm Motility in Sub-fertile Male With Asthenozoospermia
- ClinicalTrials.gov ID
- NCT07252518
- Acronym / sponsor ID
- 5721
- Conditions
- Asthenozoospermia
- Keywords
- Asthenozoospermia, Pentoxifylline, Coenzyme Q10
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Mst.Sumyara KhatunUniversity, hospital or other
- Collaborators
- Bangladesh Medical University
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 26 Nov 2025 (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 this clinical trial is to learn if drug Pentoxifylline plus Coenzyme Q10 work to treat asthenozoospermia in subfertile male. It will also learn about the safety of drug Pentoxifylline plus Coenzyme Q10. The main questions it aims to answer are:
Does drug Pentoxifylline plus Coenzyme Q10 increase the motility of sperm in participants? What medical problems do participants have when taking drug Pentoxifylline plus Coenzyme Q10 ? Researchers will compare drug Pentoxifylline plus Coenzyme Q10 combination to Coenzyme Q10 alone to see if drug Pentoxifylline plus Coenzyme Q10 combination works better.
Participants will:
Experimental Group:Pentoxifylline 400mg twice dailyand Coenzyme Q10 100mg twice daily for 3 months.
Comparator Group: Coenzyme Q10 100mg twice daily for 3 months Visit the clinic after three months of treatment for checkups and tests
Detailed description
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. A total 56 sub-fertile men with asthenozoospermia (Total motility 20% to <42%), according to WHO Laboratory manual 6th Edition in 2021, fulfilling the inclusion and exclusion criteria.will be approached for informed written consent after discussing the purpose and procedure of the study. Participants will be recruited from our OPD-2, room no-301 and referred outdoor room no-108, department of Reproductive Endocrinology \& Infertility.Baseline infertility investigations and semen analysis will be done. Detailed socio-demographic data, history, and investigations will be recorded in a predesigned data sheet. Eligible men who will give their informed consent will be randomized to either. Random sequence generation will be done by someone not involved in the study. Allocation concealment will be done by serially numbered closed opaque envelopes. Each envelope will be labeled with a serial number and will have a card noting the intervention type. Allocation will never be changed after opening the closed envelopes.At baseline, a minimum of two specimen will be collected at 4 weeks intervaland the second results showing asthenozoospermia will be considered as the baseline results.Semen sample will be collected after maintaining 3-5 days of abstinence, in the semen collection room no-110 of Reproductive Endocrinology \& Infertility, BMU by masturbation in a sterile plastic container. After getting the samples, they will be allowed to liquefy at 37 degrees Celsius and then will be analyzed according WHO,2021, in the laboratory of Reproductive Endocrinology \& Infertility department. 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. Motility evaluation will be performed within 3-5 minutes after application of the sample to avoid errors due to tendency of sperm to migrate from the periphery. All non-motile sperms will be counted within 9 or 16 squares. Then motile sperms will be counted in the same area and the grade of motility will be estimated from +1 to +4. This procedure will be repeated in another area of the grid,as well as from another 3-4 drops and the average will be calculated.
Experimental Group will receive (Pentoxifylline 400mg and Coenzyme Q10 100mg) twice daily and ComparatorGroup 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.
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 (PTX+ CoQ10) | Experimental | Combination Product: Pentoxifylline 400 MG Oral TabletParticipants receive pentoxifylline 400mg orally twice daily plus Coenzyme Q10 100mg twice daily orally |
| Active Comparator (Coenzyme Q10) | Active comparator | Dietary Supplement: Coenzyme Q 10Participants receive Coenzyme Q10 100mg twice daily orally |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sub fertile men with asthenozoospermia(Total motility20% to less than 42%) according to WHO semen analysis,2021.
- Age 20-50 years.
Key exclusion criteria (9 listed)
- Severe oligoasthenoteratozoospermia
- Any medical, endocrine and genetic disorders, history of chemotherapy or radiotherapy, genital infection, genital surgery.
- Antioxidants supplmentation in the last 3 months
- Drug, alcohol or substance abuse, psycho-sexual abnormalities.
- Any known hypersensitivity to xanthine related product, recent cerebral or retinal haemorrhage Severe oligoasthenoteratozoospermia
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 |
|---|---|---|
| Coenzyme Q 10Participants will receive Coenzyme Q10 100 mg twice daily for 3 months | Dietary supplement | Active Comparator (Coenzyme Q10) |
| Pentoxifylline 400 MG Oral TabletAlso: Coenzyme Q10Participants will receive pentoxifylline 400mg twice daily plus coenzyme Q10 100mg twice daily for 3 months | Combination product | Experimental (PTX+ CoQ10) |
Primary outcome
Progressive sperm motility
Time frame: Baseline(pre treatment) and 12 weeks after start
Percentage of sperm showing progressive motility (WHO catagories A+B) on microscopic examination,measured using WHO manual standards,after 30-60 minutes liquefaction, at 37 degree celcius, averaged over two independent readings by trained laboratory technicians blinded to treatment allocatiob
1 secondary outcome
Total sperm motility
Time frame: Baseline (pre treatment) and 12 weeks after start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 29984205Alahmar AT. The effects of oral antioxidants on the semen of men with idiopathic oligoasthenoteratozoospermia. Clin Exp Reprod Med. 2018 Jun;45(2):57-66. doi: 10.5653/cerm.2018.45.2.57. Epub 2018 Jun 29.
- Background: PubMed 37495550Barbonetti A, Tienforti D, Castellini C, Giulio FD, Muselli M, Pizzocaro A, Vena W, Baroni MG, Pivonello R, Isidori AM, Maggi M, Corona G. Effect of antioxidants on semen parameters in men with oligo-astheno-teratozoospermia: a network meta-analysis. Andrology. 2024 Mar;12(3):538-552. doi: 10.1111/andr.13498. Epub 2023 Jul 26.
- Individual participant dataSharing planned: No
Related trials for Asthenozoospermia
Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
Oligozoospermia and/or Asthenozoospermia
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
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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.
Jesmine Banu, MS principal investigator
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 Coenzyme Q 10 and Pentoxifylline 400 MG Oral Tablet 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?
The sponsor lists 2 inclusion and 9 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mst.Sumyara Khatun, MS (+8801746046581, sumirmc09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive sperm motility (time frame: Baseline(pre treatment) and 12 weeks after start). 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 NCT07252518, 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 26 Nov 2025.