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Unrecognized ConditionNCT06339996

Male Supplements for Sperm Quality and Aging

A study testing Male supplement in people with Unrecognized Condition, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study investigates the effects of a new supplement on sperm quality in men with poor sperm quality. Fifty patients will receive the supplement for three months, followed by semen analysis and assessment of sperm aging and mitochondrial function. Changes in sexual function and aging symptoms will also be evaluated. Read more about this study

Who is it for?
Ages 30 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Unrecognized Condition
What is being tested?
Male supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTaiwan
Study dates
26 Mar 2024to 31 Dec 2025
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 30 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Not meet the criteria of the 6th edition of the WHO manual for human semen analysis
  • BMI:18-30 kg/m2

Who cannot join

  • Azoospermia
  • Varicocele
  • Chromosome anomaly
  • Malignancy
  • Using hormone therapy or supplements in recent 3 months

Trial locations and contacts

1 site in 1 country.

Li-Te Lin contact

+88673464027

litelin1982@gmail.com

Taiwan1 site, 1 recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

    Li-Te Lin, +88673464027, litelin1982@gmail.com

    Kuan-Hao Tsui

    Recruiting

Other trials in Taiwan

About this study

Official title: To Investigate Supplements for Improving Male Sperm Quality and Combating Aging

This study investigates the effects of a new supplement on sperm quality in men with poor sperm quality. Fifty patients will receive the supplement for three months, followed by semen analysis and assessment of sperm aging and mitochondrial function. Changes in sexual function and aging symptoms will also be evaluated.

Read the detailed description

Due to modern lifestyle factors such as high work pressure, stressful routines, and environmental pollution, there has been a significant decline in sperm quality among men, potentially leading to infertility. In response, various supplements have emerged claiming to enhance sperm quality. This prospective investigation aims to determine the efficacy of a new supplement in improving sperm quality among patients with poor sperm quality. The study will enroll 50 patients undergoing semen analysis at our reproductive center, administering the supplement over a three-month treatment period to those identified with poor sperm quality. Subsequent semen analysis will be conducted, alongside assessments of sperm mitochondrial metabolic function before and after supplement administration. Sexual function and aging symptoms will also be evaluated using the International Index of Erectile Function (IIEF-5) and the Aging Males Symptoms Scale (AMS) before and after the supplementation period. The study aims to compare differences in semen analysis, sperm mitochondrial metabolic function, sexual function, and aging symptoms before and after supplementation.

Being tested
Male supplement
Keywords
Male supplement, Sperm quality, Aging, Mitochondrial function, Sexual function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Male supplementDietary supplement

    Participants will be administered supplements for a three-month treatment period

Study groups in NCT06339996
Study groupRoleWhat they receive
Male dietary supplementExperimentalPatients received male supplements for a three-month treatment period
Receives: Dietary Supplement: Male supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Semen analysis

    semen concentration, motility and morphology

    Measured: through study completion, an average of 1 year

Secondary outcomes (4)

  1. oxygen consumption of mitochondria

    oxygen consumption rate

    Measured: through study completion, an average of 1 year

  2. mitochondrial function

    adenosine triphosphate production

    Measured: through study completion, an average of 1 year

  3. sexual function

    International Index of Erectile Function (IIEF-5): a diagnostic tool for erectile dysfunction. The scores for the IIEF-5 range from 5 to 25. Higher scores mean a worse outcome

    Measured: through study completion, an average of 1 year

  4. aging symptoms

    Aging Males Symptoms Scale (AMS): a simple and effective way to detect whether you may have andropause. Each item is rated on a scale of 1 to 5. There are 17 in total, so the minimum score is 17 and the maximum score is 85. Higher scores mean a worse outcome.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2024
  2. Study start26 Mar 2024
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06339996
Sponsor's protocol ID
KSVGH24-CT1-10
Status last verified
Aug 2024
First submitted
25 Mar 2024
Last updated
2 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agarwal A, Baskaran S, Parekh N, Cho CL, Henkel R, Vij S, Arafa M, Panner Selvam MK, Shah R. Male infertility. Lancet. 2021 Jan 23;397(10271):319-333. doi: 10.1016/S0140-6736(20)32667-2. Epub 2020 Dec 10.

    PubMed 33308486

  • Eisenberg ML, Esteves SC, Lamb DJ, Hotaling JM, Giwercman A, Hwang K, Cheng YS. Male infertility. Nat Rev Dis Primers. 2023 Sep 14;9(1):49. doi: 10.1038/s41572-023-00459-w.

    PubMed 37709866

  • Wang C, Mbizvo M, Festin MP, Bjorndahl L, Toskin I; other Editorial Board Members of the WHO Laboratory Manual for the Examination and Processing of Human Semen. Evolution of the WHO "Semen" processing manual from the first (1980) to the sixth edition (2021). Fertil Steril. 2022 Feb;117(2):237-245. doi: 10.1016/j.fertnstert.2021.11.037. Epub 2022 Jan 5.

    PubMed 34996596

  • Hussein HA, Hassaneen ASA, Ali ME, Sindi RA, Ashour AM, Fahmy SM, Swelum AA, Ahmed AE. The Impact of Rumen-Protected L-Arginine Oral Supplementation on Libido, Semen Quality, Reproductive Organ Biometry, and Serum Biochemical Parameters of Rams. Front Vet Sci. 2022 Jun 24;9:899434. doi: 10.3389/fvets.2022.899434. eCollection 2022.

    PubMed 35812886

  • Shin D, Jeon SH, Piao J, Park HJ, Tian WJ, Moon DG, Ahn ST, Jeon KH, Zhu GQ, Park I, Park HJ, Bae WJ, Cho HJ, Hong SH, Kim SW. Efficacy and Safety of Maca (Lepidium meyenii) in Patients with Symptoms of Late-Onset Hypogonadism: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. World J Mens Health. 2023 Jul;41(3):692-700. doi: 10.5534/wjmh.220112. Epub 2023 Jan 1.

    PubMed 36593713

  • Lee HW, Lee MS, Qu F, Lee JW, Kim E. Maca (Lepidium meyenii Walp.) on semen quality parameters: A systematic review and meta-analysis. Front Pharmacol. 2022 Aug 30;13:934740. doi: 10.3389/fphar.2022.934740. eCollection 2022.

    PubMed 36110519

  • Brahmajosyula M, Morimoto Y. Exogenous GSH Supplementation to Raw Semen Alters Sperm Kinematic Parameters in Infertile Patients. Reprod Sci. 2023 Sep;30(9):2853-2865. doi: 10.1007/s43032-023-01221-z. Epub 2023 Apr 3.

    PubMed 37012490

  • Alahmar AT. Coenzyme Q10 improves sperm motility and antioxidant status in infertile men with idiopathic oligoasthenospermia. Clin Exp Reprod Med. 2022 Dec;49(4):277-284. doi: 10.5653/cerm.2022.05463. Epub 2022 Nov 4.

    PubMed 36482502

  • Nadjarzadeh A, Shidfar F, Amirjannati N, Vafa MR, Motevalian SA, Gohari MR, Nazeri Kakhki SA, Akhondi MM, Sadeghi MR. Effect of Coenzyme Q10 supplementation on antioxidant enzymes activity and oxidative stress of seminal plasma: a double-blind randomised clinical trial. Andrologia. 2014 Mar;46(2):177-83. doi: 10.1111/and.12062. Epub 2013 Jan 7.

    PubMed 23289958

  • Wang R, Wang S, Song Y, Zhou H, Pan Y, Liu L, Niu S, Liu X. Effect of vitamin E on Semen Quality Parameters: A Meta-Analysis of a Randomized Controlled Trial. Urol J. 2022 Nov 8;19(5):343-351. doi: 10.22037/uj.v19i.7160.

    PubMed 36029025

  • Alahmar AT. The Effect of Selenium Therapy on Semen Parameters, Antioxidant Capacity, and Sperm DNA Fragmentation in Men with Idiopathic Oligoasthenoteratospermia. Biol Trace Elem Res. 2023 Dec;201(12):5671-5676. doi: 10.1007/s12011-023-03638-8. Epub 2023 Mar 23.

    PubMed 36959435

  • Schisterman EF, Sjaarda LA, Clemons T, Carrell DT, Perkins NJ, Johnstone E, Lamb D, Chaney K, Van Voorhis BJ, Ryan G, Summers K, Hotaling J, Robins J, Mills JL, Mendola P, Chen Z, DeVilbiss EA, Peterson CM, Mumford SL. Effect of Folic Acid and Zinc Supplementation in Men on Semen Quality and Live Birth Among Couples Undergoing Infertility Treatment: A Randomized Clinical Trial. JAMA. 2020 Jan 7;323(1):35-48. doi: 10.1001/jama.2019.18714.

    PubMed 31910279

  • Irani M, Amirian M, Sadeghi R, Lez JL, Latifnejad Roudsari R. The Effect of Folate and Folate Plus Zinc Supplementation on Endocrine Parameters and Sperm Characteristics in Sub-Fertile Men: A Systematic Review and Meta-Analysis. Urol J. 2017 Aug 29;14(5):4069-4078.

    PubMed 28853101

  • Zhao J, Dong X, Hu X, Long Z, Wang L, Liu Q, Sun B, Wang Q, Wu Q, Li L. Zinc levels in seminal plasma and their correlation with male infertility: A systematic review and meta-analysis. Sci Rep. 2016 Mar 2;6:22386. doi: 10.1038/srep22386.

    PubMed 26932683

  • Taravati A, Tohidi F. Association between seminal plasma zinc level and asthenozoospermia: a meta-analysis study. Andrologia. 2016 Aug;48(6):646-53. doi: 10.1111/and.12494. Epub 2015 Nov 5.

    PubMed 26541500

Questions about this trial

What is this clinical trial studying?

A study testing Male supplement in people with Unrecognized Condition, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

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 5 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: status not confirmed, as of the sponsor's last update on 2 Aug 2024. 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li-Te Lin (+88673464027, litelin1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Semen analysis (time frame: through study completion, an average of 1 year). 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 NCT06339996, which also lists 17 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 2 Aug 2024.

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