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

NCT07252518 | Recruiting

• 1 other identifier: 5721
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Asthenozoospermia

Keywords

Asthenozoospermia; Pentoxifylline; Coenzyme Q10

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline(pre treatment) and 12 weeks after start

Secondary Outcomes (1)

• Total sperm motility

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

Study Arms (2)

Experimental (PTX+ CoQ10)

EXPERIMENTAL

Participants receive pentoxifylline 400mg orally twice daily plus Coenzyme Q10 100mg twice daily orally

Combination Product: Pentoxifylline 400 MG Oral Tablet

Active Comparator (Coenzyme Q10)

ACTIVE COMPARATOR

Participants receive Coenzyme Q10 100mg twice daily orally

Dietary Supplement: Coenzyme Q 10

Interventions

Coenzyme Q 10 DIETARY_SUPPLEMENT

Participants will receive Coenzyme Q10 100 mg twice daily for 3 months

Active Comparator (Coenzyme Q10)

Pentoxifylline 400 MG Oral Tablet COMBINATION_PRODUCT

Participants will receive pentoxifylline 400mg twice daily plus coenzyme Q10 100mg twice daily for 3 months

Also known as: Coenzyme Q10

Experimental (PTX+ CoQ10)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mst.Sumyara Khatun: lead
• Bangladesh Medical University: collaborator

Study Sites (1)

Bangladesh Medical University

Dhaka, Shahbag, 1000, Bangladesh

RECRUITING

Related Publications (2)

• 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.

  PMID: 29984205 BACKGROUND

• Barbonetti 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.

  PMID: 37495550 BACKGROUND

MeSH Terms

Conditions

Asthenozoospermia

Interventions

coenzyme Q10; Pentoxifylline; Tablets

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jesmine Banu, MS

  Bangladesh Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mst.Sumyara Khatun, MS

CONTACT

+8801746046581; sumirmc09@gmail.com

Kazi Jannatul Ferdouse, MBBS

CONTACT

+8801715595597; jannatulferdouse420@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical officer

Model Details: Open label parralel design randomized controlled trial

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)