Infertility, MaleNCT05506722
Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity
A study testing Testes shocker in people with Infertility, Male and Infertility Unexplained, run by University of Baghdad at 1 site in Iraq.
Trial summary
Infertility was reported in approximately 15% of all heterozygous couples, with male factor accounting for nearly half the cases. This typically occurs due to low sperm production, sperm dysfunction, and sperm delivery obstruction. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male, Infertility Unexplained, Infertility Due to Complete Spermatogenic Arrest
- What is being tested?
- Testes shocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2022to 1 Jan 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile male with oligosperma, necrospermia, asthenozoospermia or hypospermia. Must not taking any drugs or medications for infertility and has nit any congenital diseases in the genital tracts or chronic diseases.
Who cannot join
- Have congenial genital tract disease, has a chrome disease, has other than the above mentioned causes for infertility or taking medications that can affect the fertility.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Al-Dar medical Center
Nasiriyah, Thi Qar, 64001
Ali Al Imam, MBChB, 009647811535080, Ali.imami.imami@gmail.com
About this study
Official title: The Using of the Testes' Shocker in Improving the Sperms' Activity and the Spermatogenesis Process Among Infertile Men
Infertility was reported in approximately 15% of all heterozygous couples, with male factor accounting for nearly half the cases. This typically occurs due to low sperm production, sperm dysfunction, and sperm delivery obstruction. Etiology of male infertility can be attributed to many factors including acute or chronic illness, accidents, and lifestyle choices.
Read the detailed description
This study demonstrated that using a painless, convenient at-home device could significantly improve sperm motility and count. This device can be utilized to tackle (for unexplained infertility) the significant issue of infertility in a cost-effective, safe and efficacious.
- Conditions
- Infertility, Male, Infertility Unexplained, Infertility Due to Complete Spermatogenic Arrest, Oligospermia, Asthenozoospermia, Necrospermia
- Being tested
- Testes shocker
- Keywords
- Infertility, Testes shocker, Electric shocks
- Medical subject headings
- Infertility, Male, Oligospermia, Asthenozoospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testes shockerDevice
It is a device that give electric shocks (up to 5 milli Amperes) and it is designed to contain both the testes within it.
| Study group | Role | What they receive |
|---|---|---|
| Testes shocker | Active comparator | This device is working and giving the electrical shocks regularly. Receives: Device: Testes shocker |
| Fake Testes shocker | Placebo comparator | This device is not giving electricity but it is working with a red light, so the participants cannot suspect it. Receives: Device: Testes shocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen analysis
By taking the semen from the participants at baseline and then after each month and analyse it.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded two groups, one is the treated group and the other is the placebo group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
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 Talib T Hashim, MBChB, Principal investigator, University of Baghdad, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506722
- Sponsor's protocol ID
- TS2
- Status last verified
- Oct 2022
- First submitted
- 17 Aug 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Using of the Testes' Shocker in Improving the Sperms' Activity and the Spermatogenesis Process Among Infertile Men
- ClinicalTrials.gov ID
- NCT05506722
- Acronym / sponsor ID
- TS2
- Conditions
- Infertility, Male, Infertility Unexplained, Infertility Due to Complete Spermatogenic Arrest, Oligospermia, Asthenozoospermia, Necrospermia
- Keywords
- Infertility, Testes shocker, Electric shocks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 18 Aug 2022 (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.
Infertility was reported in approximately 15% of all heterozygous couples, with male factor accounting for nearly half the cases. This typically occurs due to low sperm production, sperm dysfunction, and sperm delivery obstruction. Etiology of male infertility can be attributed to many factors including acute or chronic illness, accidents, and lifestyle choices.
Detailed description
This study demonstrated that using a painless, convenient at-home device could significantly improve sperm motility and count. This device can be utilized to tackle (for unexplained infertility) the significant issue of infertility in a cost-effective, safe and efficacious.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded two groups, one is the treated group and the other is the placebo group.
| Arm | Type | Receives |
|---|---|---|
| Testes shocker | Active comparator | Device: Testes shockerThis device is working and giving the electrical shocks regularly. |
| Fake Testes shocker | Placebo comparator | Device: Testes shockerThis device is not giving electricity but it is working with a red light, so the participants cannot suspect it. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertile male with oligosperma, necrospermia, asthenozoospermia or hypospermia. Must not taking any drugs or medications for infertility and has nit any congenital diseases in the genital tracts or chronic diseases.
Key exclusion criteria (1 listed)
- Have congenial genital tract disease, has a chrome disease, has other than the above mentioned causes for infertility or taking medications that can affect the fertility.
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 |
|---|---|---|
| Testes shockerIt is a device that give electric shocks (up to 5 milli Amperes) and it is designed to contain both the testes within it. | Device | Fake Testes shocker, Testes shocker |
Primary outcome
Semen analysis
Time frame: 4 months
By taking the semen from the participants at baseline and then after each month and analyse it.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
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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 Talib T Hashim, MBChB 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 Testes shocker in people with Infertility, Male and Infertility Unexplained, 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: status not confirmed, as of the sponsor's last update on 3 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hashim Talib T Hashim, MBChB (+964780257310, hashim.h.t.h@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen analysis (time frame: 4 months). 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 3 Nov 2022.