- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04173052
Sperms Activation by Direct Electrical Shocks on Testis in Infertile Males
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Baghdad, Iraq, 60001
- Al- Nassiryah Laboratory's
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males with (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia)
Exclusion Criteria:
- Males with (Aspermia or Azoospermia)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Infertile Males
It represents the participants, all the participants in the study are infertile.
|
The device gives electrical shock ranged (1-5) milliAmpere designed to fit the testis shape for the males.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sperms movement
Time Frame: 3 months
|
Monitoring the changes that could occur in the motility of the sperms for each participant and record that.
|
3 months
|
Sperms' number
Time Frame: 3 months
|
Monitoring the changes that could occur in the numbers of the sperms for each participant and record that.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hashim T Hashim, MD, University of Baghdad / College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A12345
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
King's College LondonNot yet recruitingInfertility | Infertility, Female | Infertility Unexplained | Infertility of Tubal Origin
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Istanbul University - Cerrahpasa (IUC)RecruitingInfertility | Sexual Dysfunction | Infertility, Male | Nurse's Role | Sexuality | Infertility; FemaleTurkey
Clinical Trials on Testis' shocker
-
Kocatepe UniversityCompleted
-
University of BaghdadRecruitingInfertility, Male | Oligospermia | Asthenozoospermia | Infertility Unexplained | Infertility Due to Complete Spermatogenic Arrest | NecrospermiaIraq
-
University of BaghdadCompletedSexual Dysfunction | Erectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Sexual Abstinence | Erectile Dysfunction With Diabetes Mellitus | Sexual Desire Disorder | Erectile Dysfunction Following Cryotherapy | Erectile Dysfunction... and other conditionsIraq
-
NYU Langone HealthWithdrawnInfertility | Non-obstructive Azoospermia | VasectomyUnited States
-
dr. Muhammad Abdelhafez Mahmoud, MDCompleted
-
University of PittsburghInfertility and IVF Center, St. Louis, MOActive, not recruitingInfertility, Male | Azoospermia, NonobstructiveUnited States
-
Al-Azhar UniversityCairo UniversityCompleted
-
Acibadem UniversityCompletedAzoospermia, NonobstructiveTurkey
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedEndometrial CancerUnited States, Canada
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedKidney CancerUnited States