The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.

December 22, 2023 updated by: Lisa Yunita, Indonesia University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Male subjects aged more than 25 years and less than 45 years.
  2. 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).
  3. Willing to take part in research and sign informed consent.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jakarta Timur
      • Jakarta, Jakarta Timur, Indonesia, 13210
        • Lisa Yunita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients diagnosed with Oligozoospermia who only receive standard therapy from an Andrologist as a standard therapy.
Experimental: Intervention
Patients diagnosed with Oligozoospermia receive standard therapy from an Andrologist and Electroacupuncture.
Other: Electroacupuncture and Standard Therapy
Acupuncture Needle Insertion with Electroacupuncture machine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm analysis
Time Frame: Before Treatment in day 1, After 30 days of treatment.
Spermatozoa/mL
Before Treatment in day 1, After 30 days of treatment.
SOD Spermatozoa
Time Frame: Before Treatment in day 1, After 30 days of treatment.
Superokside Dismutase in Spermatozoa
Before Treatment in day 1, After 30 days of treatment.
SOD Plasma Semen
Time Frame: Before Treatment in day 1, After 30 days of treatment.
Superokside Dismutase in Plasma Semen
Before Treatment in day 1, After 30 days of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Lisa Yunita, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Actual)

November 26, 2023

Study Completion (Actual)

December 22, 2023

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-06-1010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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