InfertilityNCT04173052
Sperms Activation by Direct Electrical Shocks on Testis in Infertile Males
A study testing Testis' shocker in people with Infertility, run by University of Baghdad at 1 site in Iraq.
Trial summary
Background : Up to 15 percent of couples are infertile. In up to half of these couples, male infertility plays a role. Male infertility is due to low sperm production, abnormal sperm function or blockages that prevent the delivery of sperm. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Testis' shocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jun 2019to 25 Sep 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males with (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia)
Who cannot join
- Males with (Aspermia or Azoospermia)
Trial locations and contacts
1 site in 1 country.
About this study
Background :
Up to 15 percent of couples are infertile. In up to half of these couples, male infertility plays a role. Male infertility is due to low sperm production, abnormal sperm function or blockages that prevent the delivery of sperm. Illnesses, injuries, chronic health problems, lifestyle choices and other factors can play a role in causing male infertility.
Read more
Methodology :
It is an interventional trial that involved 45 participants with infertility (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia). All the participants underwent a semen analysis for his semen count, volume and motility for a sample taken by masturbation. Then I gave each one of the participants a small device. This device gives an electrical shock up to 5 milliamps. I told each one independently to use this device properly on his testis every day and come for follow up checking every month.
After the fourth months, I made the final checkup for everyone and records my data and make a comparison between (before and after) semen analysis.
Read the detailed description
Introduction :
Up to 15 percent of couples are infertile. (1) This means they aren't able to conceive a child even though they've had frequent, unprotected sexual intercourse for a year or longer. In up to half of these couples, male infertility plays a role. Male infertility is due to low sperm production, abnormal sperm function or blockages that prevent the delivery of sperm. Illnesses, injuries, chronic health problems, lifestyle choices and other factors can play a role in causing male infertility. (2,3) Not being able to conceive a child can be stressful and frustrating, but a number of male infertility treatments are available. The consequences of infertility are manifold and can include societal repercussions and personal suffering. Advances in assisted reproductive technologies, such as IVF, can offer hope to many couples where treatment is available, although barriers exist in terms of medical coverage and affordability. (4) Electrical shocks are applied in many fields to treat many diseases especially in psychiatry and mental disorders. Despite its hazards but it can be useful within range of current (Up to 5 milliamps). In 1 milliamp can cause just a faint tingle, this tingle increases as the amount of current increasing until it causes a little pain with 5 milliamps. (5,6,7)
Methodology:
It is an interventional trial that involved 45 participants with infertility (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia) aged (25 - 45 years) and all of them were married. 5 participants were excluded because they have Aspermia or Azoospermia. After clarifying the purpose and the mechanism of the study to the participants, all of them signed a written consent for each one to confirm his agreement to participate in addition to the little risks that can be brought as result of the trial if there is. The investigator applied a semen analysis at a licensed laboratory in Dhi Qar, Nassiryah city in the north of Iraq by many Laboratory assistances under the supervision of an infertility specialist. All the participants underwent a semen analysis for his semen count, volume and motility for a sample taken by masturbation. After choosing my participants and selecting their conditions. Then The investigator gave each one of the participants a small device (Created by an electrical engineer from Dhi Qar Engineering College). This device gives an electrical shock up to 5 milliamps. The investigator told each one independently to use this device properly on his testis every day and come for follow up checking every month as follow:
- The first month: 1 milliamp for the first 15 days and 2 milliamps for the second 15 days.
- The second month: 3 milliamps.
- The third month: 4 milliamps. This process continued for four months (1st June - 25th September, 2019) with regular follow up by semen analysis. After the fourth months, The investigator made the final checkup for everyone and records my data and make a comparison between (before and after) semen analysis and the follow up semen analysis using Statistical Package for the Social Science (SPSS) version 24.
Discussion:
When The investigator compared between the fourth semen analysis results, The investigator found a clear change and improvement in seminal motility, volume and count. This can be used in treating patients with infertility by applying a small amount of current on the testis from outside (taking in consideration the skin and tissues) which can improve the movement and power of the sperms gradually and it is also painless.
It is also can be used before intercourse time for those who are very hurry to fertilize an ovum so their chance of getting an embryo will increase. This device can be produced so any person with infertility (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia) can get one and use it with instructions to make his sperms more powerful to fertilize an ovum.
- Conditions
- Infertility
- Being tested
- Testis' shocker
- Keywords
- Infertility, Electrical shock, sperms activation, Semen Analysis
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testis' shockerDevice
Also called JT®
The device gives electrical shock ranged (1-5) milliAmpere designed to fit the testis shape for the males.
| Study group | Role | What they receive |
|---|---|---|
| Infertile Males | Experimental | It represents the participants, all the participants in the study are infertile. Receives: Device: Testis' shocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperms movement
Monitoring the changes that could occur in the motility of the sperms for each participant and record that.
Measured: 3 months
Sperms' number
Monitoring the changes that could occur in the numbers of the sperms for each participant and record that.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Jun 2019
- Primary completion20 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Talib Hashim, University of Baghdad
- Investigators
- Hashim T Hashim, MD, Principal investigator, University of Baghdad / College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173052
- Sponsor's protocol ID
- A12345
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hashim HT, Varney J, Qais Z, Reda A, Qaderi S, Chowdhury NS, Murry K, Shah J, Alhaideri A, Ahmad S, Hashim AT, Rehman R, Ahmed N, Al-Jorani MS, Skuk M, Abdalhusain M, Khalafalla K. Direct and Gradual Electrical Testicular Shocks Stimulate Spermatogenesis and Activate Sperms in Infertile Men: A Randomized Controlled Trial. Am J Mens Health. 2024 Nov-Dec;18(6):15579883241296881. doi: 10.1177/15579883241296881.
PubMed 39601214
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperms Activation by Direct Electrical Shocks on Testis in Infertile Males
- ClinicalTrials.gov ID
- NCT04173052
- Acronym / sponsor ID
- A12345
- Conditions
- Infertility
- Keywords
- Infertility, Electrical shock, sperms activation, Semen Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 21 Nov 2019 (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.
Background :
Up to 15 percent of couples are infertile. In up to half of these couples, male infertility plays a role. Male infertility is due to low sperm production, abnormal sperm function or blockages that prevent the delivery of sperm. Illnesses, injuries, chronic health problems, lifestyle choices and other factors can play a role in causing male infertility.
Methodology :
It is an interventional trial that involved 45 participants with infertility (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia). All the participants underwent a semen analysis for his semen count, volume and motility for a sample taken by masturbation. Then I gave each one of the participants a small device. This device gives an electrical shock up to 5 milliamps. I told each one independently to use this device properly on his testis every day and come for follow up checking every month.
After the fourth months, I made the final checkup for everyone and records my data and make a comparison between (before and after) semen analysis.
Detailed description
Introduction :
Up to 15 percent of couples are infertile. (1) This means they aren't able to conceive a child even though they've had frequent, unprotected sexual intercourse for a year or longer. In up to half of these couples, male infertility plays a role. Male infertility is due to low sperm production, abnormal sperm function or blockages that prevent the delivery of sperm. Illnesses, injuries, chronic health problems, lifestyle choices and other factors can play a role in causing male infertility. (2,3) Not being able to conceive a child can be stressful and frustrating, but a number of male infertility treatments are available. The consequences of infertility are manifold and can include societal repercussions and personal suffering. Advances in assisted reproductive technologies, such as IVF, can offer hope to many couples where treatment is available, although barriers exist in terms of medical coverage and affordability. (4) Electrical shocks are applied in many fields to treat many diseases especially in psychiatry and mental disorders. Despite its hazards but it can be useful within range of current (Up to 5 milliamps). In 1 milliamp can cause just a faint tingle, this tingle increases as the amount of current increasing until it causes a little pain with 5 milliamps. (5,6,7)
Methodology:
It is an interventional trial that involved 45 participants with infertility (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia) aged (25 - 45 years) and all of them were married. 5 participants were excluded because they have Aspermia or Azoospermia. After clarifying the purpose and the mechanism of the study to the participants, all of them signed a written consent for each one to confirm his agreement to participate in addition to the little risks that can be brought as result of the trial if there is. The investigator applied a semen analysis at a licensed laboratory in Dhi Qar, Nassiryah city in the north of Iraq by many Laboratory assistances under the supervision of an infertility specialist. All the participants underwent a semen analysis for his semen count, volume and motility for a sample taken by masturbation. After choosing my participants and selecting their conditions. Then The investigator gave each one of the participants a small device (Created by an electrical engineer from Dhi Qar Engineering College). This device gives an electrical shock up to 5 milliamps. The investigator told each one independently to use this device properly on his testis every day and come for follow up checking every month as follow:
- The first month: 1 milliamp for the first 15 days and 2 milliamps for the second 15 days.
- The second month: 3 milliamps.
- The third month: 4 milliamps. This process continued for four months (1st June - 25th September, 2019) with regular follow up by semen analysis. After the fourth months, The investigator made the final checkup for everyone and records my data and make a comparison between (before and after) semen analysis and the follow up semen analysis using Statistical Package for the Social Science (SPSS) version 24.
Discussion:
When The investigator compared between the fourth semen analysis results, The investigator found a clear change and improvement in seminal motility, volume and count. This can be used in treating patients with infertility by applying a small amount of current on the testis from outside (taking in consideration the skin and tissues) which can improve the movement and power of the sperms gradually and it is also painless.
It is also can be used before intercourse time for those who are very hurry to fertilize an ovum so their chance of getting an embryo will increase. This device can be produced so any person with infertility (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia) can get one and use it with instructions to make his sperms more powerful to fertilize an ovum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile Males | Experimental | Device: Testis' shockerIt represents the participants, all the participants in the study are infertile. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males with (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia)
Key exclusion criteria (1 listed)
- Males with (Aspermia or 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 |
|---|---|---|
| Testis' shockerAlso: JT®The device gives electrical shock ranged (1-5) milliAmpere designed to fit the testis shape for the males. | Device | Infertile Males |
Primary outcome
Sperms movement
Time frame: 3 months
Monitoring the changes that could occur in the motility of the sperms for each participant and record that.
Sperms' number
Time frame: 3 months
Monitoring the changes that could occur in the numbers of the sperms for each participant and record that.
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 22 Nov 2019.
- Derived from this study: PubMed 39601214Hashim HT, Varney J, Qais Z, Reda A, Qaderi S, Chowdhury NS, Murry K, Shah J, Alhaideri A, Ahmad S, Hashim AT, Rehman R, Ahmed N, Al-Jorani MS, Skuk M, Abdalhusain M, Khalafalla K. Direct and Gradual Electrical Testicular Shocks Stimulate Spermatogenesis and Activate Sperms in Infertile Men: A Randomized Controlled Trial. Am J Mens Health. 2024 Nov-Dec;18(6):15579883241296881. doi: 10.1177/15579883241296881.
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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.
Hashim T Hashim, MD principal investigator
University of Baghdad / College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testis' shocker in people with Infertility, run by University of Baghdad at 1 site in Iraq.
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 1 inclusion and 1 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 22 Nov 2019. 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 Iraq. 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?
Sperms movement (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04173052, which also lists 1 linked publication.
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 22 Nov 2019.