Effect of Pentoxifylline + CoQ10 vs CoQ10 Alone on Sperm Motility in Subfertile Men With Asthenozoospermia

November 24, 2025 updated by: Mst.Sumyara Khatun

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

56

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 Contact

Study Contact Backup

Study Locations

  • Bangladesh
    • Shahbag
      • Dhaka, Shahbag, Bangladesh, 1000
        • Recruiting
        • Bangladesh Medical University
        • Contact:
          • Mst Sumyara Khatun Medical officer, MS
          • Phone Number: +8801746046581
          • Email: sumirmc09@gmail.com
        • Contact:
        • Principal Investigator:
          • Kazi Jannatul Ferdouse
        • Sub-Investigator:
          • Jemine Banu, MS

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

Inclusion Criteria:

  • Sub fertile men with asthenozoospermia(Total motility20% to less than 42%) according to WHO semen analysis,2021.
  • Age 20-50 years.

Exclusion Criteria:

  • 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.
  • 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

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 (PTX+ CoQ10)
Participants receive pentoxifylline 400mg orally twice daily plus Coenzyme Q10 100mg twice daily orally
Combination product: Pentoxifylline 400 MG Oral Tablet
Participants will receive pentoxifylline 400mg twice daily plus coenzyme Q10 100mg twice daily for 3 months
Other Names:
  • Coenzyme Q10
Active Comparator: Active Comparator (Coenzyme Q10)
Participants receive Coenzyme Q10 100mg twice daily orally
Dietary supplement: Coenzyme Q 10
Participants will receive Coenzyme Q10 100 mg twice daily for 3 months

What is the study measuring?

Primary 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 (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
Baseline(pre treatment) and 12 weeks after start

Secondary 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 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.
Baseline (pre treatment) and 12 weeks after start of treatment

Collaborators and Investigators

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

Sponsor

Mst.Sumyara Khatun

Collaborators

Bangladesh Medical University

Investigators

  • Principal Investigator: Jesmine Banu, MS, 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)

October 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

September 17, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5721

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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