Back to resultsUsing of Testes Shocker in Improving the Spermatogenesis and Sperms Activity
Primary Purpose
Infertility, Male, Infertility Unexplained, Infertility Due to Complete Spermatogenic Arrest
Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Testes shocker
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Male focused on measuring Infertility, Testes shocker, Electric shocks
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Al-Dar medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Testes shocker
Fake Testes shocker
Arm Description
This device is working and giving the electrical shocks regularly.
This device is not giving electricity but it is working with a red light, so the participants cannot suspect it.
Outcomes
Primary Outcome Measures
Semen analysis
By taking the semen from the participants at baseline and then after each month and analyse it.
Secondary Outcome Measures
Full Information
NCT ID
NCT05506722
First Posted
August 17, 2022
Last Updated
October 31, 2022
Sponsor
University of Baghdad
1. Study Identification
Unique Protocol Identification Number
NCT05506722
Brief Title
Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity
Official Title
The Using of the Testes' Shocker in Improving the Sperms' Activity and the Spermatogenesis Process Among Infertile Men
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male, Infertility Unexplained, Infertility Due to Complete Spermatogenic Arrest, Oligospermia, Asthenozoospermia, Necrospermia
Keywords
Infertility, Testes shocker, Electric shocks
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded two groups, one is the treated group and the other is the placebo group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
By mixing the devices together and giving them to the participants blindly.
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Testes shocker
Arm Type
Active Comparator
Arm Description
This device is working and giving the electrical shocks regularly.
Arm Title
Fake Testes shocker
Arm Type
Placebo Comparator
Arm Description
This device is not giving electricity but it is working with a red light, so the participants cannot suspect it.
Intervention Type
Device
Intervention Name(s)
Testes shocker
Intervention Description
It is a device that give electric shocks (up to 5 milli Amperes) and it is designed to contain both the testes within it.
Primary Outcome Measure Information:
Title
Semen analysis
Description
By taking the semen from the participants at baseline and then after each month and analyse it.
Time Frame
4 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only those who consider themselves as males and have males genital organs of penis and testes were included.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hashim Talib T Hashim, MBChB
Phone
+964780257310
Email
hashim.h.t.h@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim Talib T Hashim, MBChB
Organizational Affiliation
University of Baghdad, College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Dar medical Center
City
Nasiriyah
State/Province
Thi Qar
ZIP/Postal Code
64001
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Al Imam, MBChB
Phone
009647811535080
Email
Ali.imami.imami@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity
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