Male Supplements for Sperm Quality and Aging | NCT06339996

Studies
Male Supplements for Sperm Quality and Aging

NCT06339996

Sponsor

Kaohsiung Veterans General Hospital.

Status

Recruiting

Last Update Posted

Aug 2, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Unrecognized Condition

Interventions

Male supplement

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2024Actual

Primary Completion Date

Oct 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 25, 2024

First Submission Date that Met QC Criteria

Mar 25, 2024

First Posted Date

Apr 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2024

Last Update Posted Date

Aug 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Li-Te Lin, Doctor, Kaohsiung Veterans General Hospital.Principal Investigator

Lead Sponsor

Kaohsiung Veterans General Hospital.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Male dietary supplement	Experimental	Patients received male supplements for a three-month treatment period	Dietary Supplement: Male supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Male supplement	Dietary Supplement	Participants will be administered supplements for a three-month treatment period	Male dietary supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Semen analysis	semen concentration, motility and morphology	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
oxygen consumption of mitochondria	oxygen consumption rate	through study completion, an average of 1 year
mitochondrial function	adenosine triphosphate production

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li-Te Lin	Contact	+88673464027		litelin1982@gmail.com

Overall Officials

Name	Affiliation	Role
Kuan-Hao Tsui	Kaohsiung Veterans General Hospital.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Veterans General Hospital	Recruiting	Kaohsiung City			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33308486	Background	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.
37709866	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.