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RecruitingNCT06339996Updated Aug 2, 2024

Male Supplements for Sperm Quality and Aging

An interventional study of Male supplement in Unrecognized Condition, sponsored by Kaohsiung Veterans General Hospital.. Recruiting at 1 site in Taiwan. Open to male participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Kaohsiung Veterans General Hospital. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
30 Years to 50 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Unrecognized Condition

Keywords

  • Male supplement
  • Sperm quality
  • Aging
  • Mitochondrial function
  • Sexual function
03

In context

Lead sponsor

Kaohsiung Veterans General Hospital. is the lead sponsor of 102 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Azoospermia
  • Varicocele
  • Chromosome anomaly
  • Malignancy
  • Using hormone therapy or supplements in recent 3 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Male dietary supplement

    Patients received male supplements for a three-month treatment period

    Dietary Supplement: Male supplement

Interventions

  • Dietary supplementMale supplement

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

06

What researchers measure

Primary outcomes

  1. Semen analysis

    semen concentration, motility and morphology

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. oxygen consumption of mitochondria

    oxygen consumption rate

    Time frame: through study completion, an average of 1 year

  2. mitochondrial function

    adenosine triphosphate production

    Time frame: 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

    Time frame: 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.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Veterans General Hospital
    Kaohsiung, Taiwan
    Recruiting
08

References and documents

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. Erratum In: JAMA. 2020 Mar 24;323(12):1194. doi: 10.1001/jama.2020.2066. 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 ↗
  • Dimitriadis F, Borgmann H, Struck JP, Salem J, Kuru TH. Antioxidant Supplementation on Male Fertility-A Systematic Review. Antioxidants (Basel). 2023 Mar 30;12(4):836. doi: 10.3390/antiox12040836. PubMed 37107211 ↗
  • Li KP, Yang XS, Wu T. The Effect of Antioxidants on Sperm Quality Parameters and Pregnancy Rates for Idiopathic Male Infertility: A Network Meta-Analysis of Randomized Controlled Trials. Front Endocrinol (Lausanne). 2022 Feb 21;13:810242. doi: 10.3389/fendo.2022.810242. eCollection 2022. PubMed 35265037 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06339996
Lead sponsor
Kaohsiung Veterans General Hospital.
Responsible party
Li-Te Lin (Doctor, Kaohsiung Veterans General Hospital.) — Principal investigator
First posted
Apr 1, 2024
Start date
Mar 26, 2024
Primary completion
Oct 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 2, 2024

Study contacts

Li-Te Lin
Contact
litelin1982@gmail.com
+88673464027
Kuan-Hao Tsui
study director · Kaohsiung Veterans General Hospital.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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