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NCT Number: NCT06339996

Male Supplements for Sperm Quality and 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.

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Key information

Conditions

Unrecognized Condition

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location status: Recruiting

Location contact

Kuan-Hao Tsui

CONTACT

Li-Te Lin

CONTACT

[email protected]

+88673464027

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Male supplement

Dietary Supplement

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

Primary outcomes

  1. Semen analysis

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

    semen concentration, motility and morphology

Secondary outcomes

  1. oxygen consumption of mitochondria

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

    oxygen consumption rate

  2. mitochondrial function

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

    adenosine triphosphate production

  3. sexual function

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

    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

  4. aging symptoms

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Li-Te Lin

CONTACT

[email protected]

+88673464027

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

To Investigate Supplements for Improving Male Sperm Quality and Combating Aging

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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