Male Supplements for Sperm Quality and Aging

NCT06339996 | Recruiting

• 1 other identifier: KSVGH24-CT1-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unrecognized Condition

Keywords

Male supplement; Sperm quality; Aging; Mitochondrial function; Sexual function

Outcome Measures

Primary Outcomes (1)

• Semen analysis

  semen concentration, motility and morphology

  through study completion, an average of 1 year

Secondary Outcomes (4)

• oxygen consumption of mitochondria

  through study completion, an average of 1 year

• mitochondrial function

  through study completion, an average of 1 year

• sexual function

  through study completion, an average of 1 year

• aging symptoms

  through study completion, an average of 1 year

Study Arms (1)

Male dietary supplement

EXPERIMENTAL

Patients received male supplements for a three-month treatment period

Dietary Supplement: Male supplement

Interventions

Male supplement DIETARY_SUPPLEMENT

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

Male dietary supplement

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

RECRUITING

Related Publications (17)

• 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.

  PMID: 33308486 BACKGROUND

• 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.

  PMID: 37709866 BACKGROUND

• 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.

  PMID: 34996596 BACKGROUND

• 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.

  PMID: 35812886 BACKGROUND

• 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.

  PMID: 36593713 BACKGROUND

• 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.

  PMID: 36110519 BACKGROUND

• 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.

  PMID: 37012490 BACKGROUND

• 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.

  PMID: 36482502 BACKGROUND

• 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.

  PMID: 23289958 BACKGROUND

• 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.

  PMID: 36029025 BACKGROUND

• 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.

  PMID: 36959435 BACKGROUND

• 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.

  PMID: 31910279 BACKGROUND

• 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.

  PMID: 28853101 BACKGROUND

• 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.

  PMID: 26932683 BACKGROUND

• 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.

  PMID: 26541500 BACKGROUND

• 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.

  PMID: 37107211 BACKGROUND

• 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.

  PMID: 35265037 BACKGROUND

Study Officials

• Kuan-Hao Tsui

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

Central Study Contacts

Li-Te Lin

CONTACT

+88673464027; litelin1982@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: March 26, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)