ClinicalTrials.gg
CompletedNCT06088693Updated Dec 28, 2023

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

An interventional study of Electroacupuncture and Standard Therapy in Oligozoospermia, Oligoasthenozoospermia and Oligoasthenoteratozoospermia, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to male participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-12-28.

Sponsored by Indonesia University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
Male
01

Study 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.

Read the 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.
02

Conditions studied

  • Oligozoospermia
  • Oligoasthenozoospermia
  • Oligoasthenoteratozoospermia

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03

In context

Oligospermia

64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.

This study's enrollment of 48 is below the median of 65 across 46 interventional studies indexed under Oligospermia.

Browse Oligospermia studies →

Lead sponsor

Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • 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

Interventions

  • OtherElectroacupuncture and Standard Therapy

    Acupuncture Needle Insertion with Electroacupuncture machine.

06

What researchers measure

Primary outcomes

  1. Sperm analysis

    Spermatozoa/mL

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

  2. SOD Spermatozoa

    Superokside Dismutase in Spermatozoa

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

  3. SOD Plasma Semen

    Superokside Dismutase in Plasma Semen

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

07

Study locations

1 site
  • Lisa Yunita
    Jakarta, Jakarta Timur 13210, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2023 to primary completion in Nov 2023, 2 months.

Of 16 interventional studies with no phase under Oligospermia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 36. This study's 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2023
First posted
Oct 18, 2023
StartActual
Sep 11, 2023
Primary completionActual
Nov 26, 2023
CompletionActual
Dec 22, 2023
Last update
Dec 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06088693
Responsible party
Lisa Yunita (Medical Doctor, Indonesia University) — Principal investigator
First posted
Oct 18, 2023
Start date
Sep 11, 2023
Primary completion
Nov 26, 2023
Completion
Dec 22, 2023
Last update
Dec 28, 2023

Study contacts

Lisa Yunita
principal investigator · Indonesia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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