Back to resultsThe Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
Primary Purpose
Oligozoospermia, Oligoasthenozoospermia, Oligoasthenoteratozoospermia
Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Electroacupuncture and Standard Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Oligozoospermia
Eligibility Criteria
Inclusion Criteria: Male 25 to 45 years old. Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (<5 million spermatozoa/mL). Willing to participate in research and sign informed consent. Exclusion Criteria: Emergency case patient / bleeding disorders Have a tumor, scar tissue or infected wound in the area where the acupuncture needle will be inserted. Alcoholic Using a pacemaker (heart pacemaker). Azoospermia Varicocele
Sites / Locations
- Lisa YunitaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Patients diagnosed with Oligozoospermia who only receive standard therapy from an Andrologist as a standard therapy.
Patients diagnosed with Oligozoospermia receive standard therapy from an Andrologist and Electroacupuncture.
Outcomes
Primary Outcome Measures
Sperm analysis
Spermatozoa/mL
SOD Spermatozoa
Superokside Dismutase in Spermatozoa
SOD Plasma Semen
Superokside Dismutase in Plasma Semen
Secondary Outcome Measures
Full Information
NCT ID
NCT06088693
First Posted
September 11, 2023
Last Updated
October 12, 2023
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT06088693
Brief Title
The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
Official Title
The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this clinical trial is to compare in Oligozoospermia Patient. The main questions it aims to answer are: 1. Electroacupuncture therapy and standard therapy can affect oligozoospermia. 2. Electroacupuncture therapy and standard therapy can affect semen and spermatozoa plasma SOD levels.
Researchers will compare patient with standard therapy with patient with standard therapy with electroacupuncture.
Detailed Description
Male subjects aged more than 25 years and less than 45 years.
Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (<5 million spermatozoa/mL).
Willing to take part in research and sign informed consent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligozoospermia, Oligoasthenozoospermia, Oligoasthenoteratozoospermia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The investigator blind the participant allocation
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients diagnosed with Oligozoospermia who only receive standard therapy from an Andrologist as a standard therapy.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients diagnosed with Oligozoospermia receive standard therapy from an Andrologist and Electroacupuncture.
Intervention Type
Other
Intervention Name(s)
Electroacupuncture and Standard Therapy
Intervention Description
Acupuncture Needle Insertion with Electroacupuncture machine.
Primary Outcome Measure Information:
Title
Sperm analysis
Description
Spermatozoa/mL
Time Frame
Before Treatment in day 1, After 30 days of treatment.
Title
SOD Spermatozoa
Description
Superokside Dismutase in Spermatozoa
Time Frame
Before Treatment in day 1, After 30 days of treatment.
Title
SOD Plasma Semen
Description
Superokside Dismutase in Plasma Semen
Time Frame
Before Treatment in day 1, After 30 days of treatment.
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male with Oligozoospermia, Oligoasthenozoospermia, Oligoasthenoteratozoospermia, Oligoteratozoospermia.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male 25 to 45 years old.
Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (<5 million spermatozoa/mL).
Willing to participate in research and sign informed consent.
Exclusion Criteria:
Emergency case patient / bleeding disorders
Have a tumor, scar tissue or infected wound in the area where the acupuncture needle will be inserted.
Alcoholic
Using a pacemaker (heart pacemaker).
Azoospermia
Varicocele
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Yunita
Phone
081385662211
Email
dokterlisayunita@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Yunita
Phone
081807016685
Email
cwepalingcanggih@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Yunita
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lisa Yunita
City
Jakarta
State/Province
Jakarta Timur
ZIP/Postal Code
13210
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Yunita
Phone
081807016685
Email
dokterlisayunita@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
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