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Recruiting NCT06339996

Male Supplements for Sperm Quality and Aging

No phase Interventional Unrecognized Condition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Male supplement.
Who it may be relevant to
Registry conditions: Unrecognized Condition. Basic parameters: 30 years — 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

To Investigate Supplements for Improving Male Sperm Quality and Combating Aging

Overview

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.

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.

Interventions

  • Dietary supplement Male supplement
    Participants will be administered supplements for a three-month treatment period

Primary outcome measures

  • Semen analysis [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (4)
  • oxygen consumption of mitochondria [Time frame: through study completion, an average of 1 year]
  • mitochondrial function [Time frame: through study completion, an average of 1 year]
  • sexual function [Time frame: through study completion, an average of 1 year]
  • aging symptoms [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Kaohsiung Veterans General Hospital — Kaohsiung City

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 36482502

Identifiers

NCT: NCT06339996 · KSVGH24-CT1-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗