An interventional study of Coenzyme Q 10 and Pentoxifylline 400 MG Oral Tablet in Asthenozoospermia, sponsored by Mst.Sumyara Khatun. Recruiting at 1 site in Bangladesh. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Mst.Sumyara Khatun · Not applicable, Interventional, and Treatment
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
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.
32 studies on the registry are indexed under Asthenozoospermia; 9 are open to participants now.
This study's planned enrollment of 56 is close to the median of 62 across 25 interventional studies indexed under Asthenozoospermia.
Browse Asthenozoospermia studies →Mst.Sumyara Khatun is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive pentoxifylline 400mg orally twice daily plus Coenzyme Q10 100mg twice daily orally
Combination Product: Pentoxifylline 400 MG Oral Tablet
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
Participants will receive pentoxifylline 400mg twice daily plus coenzyme Q10 100mg twice daily for 3 months
Also known as: Coenzyme Q10
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
Time frame: Baseline(pre treatment) and 12 weeks after start
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.
Time frame: Baseline (pre treatment) and 12 weeks after start of treatment
Plan to share: No
Started Oct 2025 (actual). Primary completion is estimated for Jul 2026, 9 months after the start.
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Studies of the drug tested here: Pentoxifylline
Mst.Sumyara Khatun