Male Supplements for Sperm Quality and Aging

Not Applicable

Recruiting

• Conditions: Unrecognized Condition
• Interventions: Dietary Supplement: Male supplement

• Registration Number: NCT06339996
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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.

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.

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study Start: 2024-03-26
• Study First Posted: 2024-04-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Male dietary supplement	Male supplement	Patients received male supplements for a three-month treatment period

Primary Outcome Measures

Name	Time	Method
Semen analysis	through study completion, an average of 1 year	semen concentration, motility and morphology

Secondary Outcome Measures

Name	Time	Method
sexual function	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
oxygen consumption of mitochondria	through study completion, an average of 1 year	oxygen consumption rate
mitochondrial function	through study completion, an average of 1 year	adenosine triphosphate production
aging symptoms	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.

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan