Using of Testes Shocker in Improving the Spermatogenesis... | NCT05506722

Studies
Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity

NCT05506722

Sponsor

University of Baghdad

Status

Unknown status

Last Update Posted

Nov 3, 2022Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Infertility, Male
Infertility Unexplained
Infertility Due to Complete Spermatogenic Arrest
Oligospermia
Asthenozoospermia
Necrospermia

Interventions

Testes shocker

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Aug 17, 2022

First Submission Date that Met QC Criteria

Aug 17, 2022

First Posted Date

Aug 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2022

Last Update Posted Date

Nov 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Testes shocker	Active Comparator	This device is working and giving the electrical shocks regularly.	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.	Device: Testes shocker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testes shocker	Device	It is a device that give electric shocks (up to 5 milli Amperes) and it is designed to contain both the testes within it.	Fake Testes shocker

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Semen analysis	By taking the semen from the participants at baseline and then after each month and analyse it.	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only those who consider themselves as males and have males genital organs of penis and testes were included.

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hashim Talib T Hashim, MBChB	Contact	+964780257310		hashim.h.t.h@gmail.com

Overall Officials

Name	Affiliation	Role
Hashim Talib T Hashim, MBChB	University of Baghdad, College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Dar medical Center	Recruiting	Nasiriyah	Thi Qar	64001	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male
D009845	Oligospermia
D053627	Asthenozoospermia
D007246	Infertility

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

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Browse Branches

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