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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06088693
Other study ID # 23-06-1010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date December 22, 2023

Study information

Verified date December 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 22, 2023
Est. primary completion date November 26, 2023
Accepts healthy volunteers No
Gender Male
Age group 25 Years to 45 Years
Eligibility 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 Design


Intervention

Other:
Electroacupuncture and Standard Therapy
Acupuncture Needle Insertion with Electroacupuncture machine.

Locations

Country Name City State
Indonesia Lisa Yunita Jakarta Jakarta Timur

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sperm analysis Spermatozoa/mL Before Treatment in day 1, After 30 days of treatment.
Primary SOD Spermatozoa Superokside Dismutase in Spermatozoa Before Treatment in day 1, After 30 days of treatment.
Primary SOD Plasma Semen Superokside Dismutase in Plasma Semen Before Treatment in day 1, After 30 days of treatment.
See also
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Completed NCT03344588 - The Role of Artery-Preserving Varicocelectomy in Subfertile Men With Severe Oligozoospermia. N/A
Completed NCT02900105 - Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia. Phase 3
Recruiting NCT05628987 - The Association of Gut Microbiota and Spermatogenic Dysfunction