OligozoospermiaNCT06088693
The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
A study testing Electroacupuncture and Standard Therapy in people with Oligozoospermia and Oligoasthenozoospermia, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men only
- Conditions the study is for
- Oligozoospermia, Oligoasthenozoospermia, Oligoasthenoteratozoospermia
- What is being tested?
- Electroacupuncture and Standard Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Sep 2023to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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.
- Being tested
- Electroacupuncture and Standard Therapy
- Medical subject headings
- Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture and Standard TherapyOther
Acupuncture Needle Insertion with Electroacupuncture machine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electroacupuncture and Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm analysis
Spermatozoa/mL
Measured: Before Treatment in day 1, After 30 days of treatment.
SOD Spermatozoa
Superokside Dismutase in Spermatozoa
Measured: Before Treatment in day 1, After 30 days of treatment.
SOD Plasma Semen
Superokside Dismutase in Plasma Semen
Measured: Before Treatment in day 1, After 30 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start11 Sep 2023
- Primary completion26 Nov 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligozoospermiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Yunita, Universitas Indonesia
- Investigators
- Lisa Yunita, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088693
- Sponsor's protocol ID
- 23-06-1010
- Status last verified
- Dec 2023
- First submitted
- 11 Sep 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
- ClinicalTrials.gov ID
- NCT06088693
- Acronym / sponsor ID
- 23-06-1010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 26 Nov 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients diagnosed with Oligozoospermia who only receive standard therapy from an Andrologist as a standard therapy. |
| Intervention | Experimental | Other: Electroacupuncture and Standard TherapyPatients diagnosed with Oligozoospermia receive standard therapy from an Andrologist and Electroacupuncture. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroacupuncture and Standard TherapyAcupuncture Needle Insertion with Electroacupuncture machine. | Other | Intervention |
Primary outcome
Sperm analysis
Time frame: Before Treatment in day 1, After 30 days of treatment.
Spermatozoa/mL
SOD Spermatozoa
Time frame: Before Treatment in day 1, After 30 days of treatment.
Superokside Dismutase in Spermatozoa
SOD Plasma Semen
Time frame: Before Treatment in day 1, After 30 days of treatment.
Superokside Dismutase in Plasma Semen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Oligozoospermia
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Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
Oligoasthenoteratozoospermia, Male Infertility
Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
Oligozoospermia and/or Asthenozoospermia
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Efficacy and Safety of a New Sperm Capacitation Method
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Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men
Azoospermia, Nonobstructive, Cryptozoospermia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Yunita principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Standard Therapy in people with Oligozoospermia and Oligoasthenozoospermia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm analysis (time frame: Before Treatment in day 1, After 30 days of treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.