Sperms Activation by Direct Electrical Shocks on Testis in Infertile Males
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Testis' shocker
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Infertility, Electrical shock, sperms activation, Semen Analysis
Eligibility Criteria
Inclusion Criteria:
- Males with (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia)
Exclusion Criteria:
- Males with (Aspermia or Azoospermia)
Sites / Locations
- Al- Nassiryah Laboratory's
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infertile Males
Arm Description
It represents the participants, all the participants in the study are infertile.
Outcomes
Primary Outcome Measures
Sperms movement
Monitoring the changes that could occur in the motility of the sperms for each participant and record that.
Sperms' number
Monitoring the changes that could occur in the numbers of the sperms for each participant and record that.
Secondary Outcome Measures
Full Information
NCT ID
NCT04173052
First Posted
November 18, 2019
Last Updated
November 20, 2019
Sponsor
University of Baghdad
1. Study Identification
Unique Protocol Identification Number
NCT04173052
Brief Title
Sperms Activation by Direct Electrical Shocks on Testis in Infertile Males
Official Title
Sperms Activation by Direct Electrical Shocks on Testis in Infertile Males
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Electrical shock, sperms activation, Semen Analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infertile Males
Arm Type
Experimental
Arm Description
It represents the participants, all the participants in the study are infertile.
Intervention Type
Device
Intervention Name(s)
Testis' shocker
Other Intervention Name(s)
JT®
Intervention Description
The device gives electrical shock ranged (1-5) milliAmpere designed to fit the testis shape for the males.
Primary Outcome Measure Information:
Title
Sperms movement
Description
Monitoring the changes that could occur in the motility of the sperms for each participant and record that.
Time Frame
3 months
Title
Sperms' number
Description
Monitoring the changes that could occur in the numbers of the sperms for each participant and record that.
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males with (Oligospermia, Hypospermia, Asthenozoospermia and Necrozoospermia)
Exclusion Criteria:
Males with (Aspermia or Azoospermia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim T Hashim, MD
Organizational Affiliation
University of Baghdad / College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al- Nassiryah Laboratory's
City
Baghdad
ZIP/Postal Code
60001
Country
Iraq
12. IPD Sharing Statement
Learn more about this trial
Sperms Activation by Direct Electrical Shocks on Testis in Infertile Males
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