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

NCT06088693 | Completed DMC

• 1 other identifier: 23-06-1010
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Oligozoospermia; Oligoasthenozoospermia; Oligoasthenoteratozoospermia

Outcome Measures

Primary Outcomes (3)

• Sperm analysis

  Spermatozoa/mL

  Before Treatment in day 1, After 30 days of treatment.

• SOD Spermatozoa

  Superokside Dismutase in Spermatozoa

  Before Treatment in day 1, After 30 days of treatment.

• SOD Plasma Semen

  Superokside Dismutase in Plasma Semen

  Before Treatment in day 1, After 30 days of treatment.

Study Arms (2)

Control

NO INTERVENTION

Patients diagnosed with Oligozoospermia who only receive standard therapy from an Andrologist as a standard therapy.

Intervention

EXPERIMENTAL

Patients diagnosed with Oligozoospermia receive standard therapy from an Andrologist and Electroacupuncture.

Other: Electroacupuncture and Standard Therapy

Interventions

Electroacupuncture and Standard Therapy OTHER

Acupuncture Needle Insertion with Electroacupuncture machine.

Intervention

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Male with Oligozoospermia, Oligoasthenozoospermia, Oligoasthenoteratozoospermia, Oligoteratozoospermia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Lisa Yunita

Jakarta, Jakarta Timur, 13210, Indonesia

Location

MeSH Terms

Conditions

Oligospermia

Interventions

Electroacupuncture; Standard of Care

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lisa Yunita

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The investigator blind the participant allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 18, 2023
• Study Start: September 11, 2023
• Primary Completion: November 26, 2023
• Study Completion: December 22, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)