Clinical trial NCT06339996: Male Supplements for Sperm Quality and Aging
Official title: To Investigate Supplements for Improving Male Sperm Quality and Combating Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unrecognized Condition
Keywords: Male supplement
Sperm quality
Aging
Mitochondrial function
Sexual function
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 50
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Semen analysis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: oxygen consumption of mitochondria
timeFrame: through study completion, an average of 1 year
measure: mitochondrial function
timeFrame: through study completion, an average of 1 year
measure: sexual function
timeFrame: through study completion, an average of 1 year
measure: aging symptoms
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Kuan-Hao Tsui
role: STUDY_DIRECTOR
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