Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity

Sponsor

University of Baghdad (Other)

Overall Status

Recruiting

CT.gov ID

NCT05506722

Collaborator

(none)

250

Enrollment

Location

Arms

Anticipated Duration (Months)

62.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male Infertility Unexplained Infertility Due to Complete Spermatogenic Arrest Oligospermia Asthenozoospermia Necrospermia	Device: Testes shocker	Phase 3

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

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blinded two groups, one is the treated group and the other is the placebo group.Double blinded two groups, one is the treated group and the other is the placebo group.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

By mixing the devices together and giving them to the participants blindly.

Primary Purpose:

Treatment

Official Title:

The Using of the Testes' Shocker in Improving the Sperms' Activity and the Spermatogenesis Process Among Infertile Men

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Testes shocker This device is working and giving the electrical shocks regularly.	Device: Testes shocker It is a device that give electric shocks (up to 5 milli Amperes) and it is designed to contain both the testes within it.
Placebo Comparator: Fake Testes shocker This device is not giving electricity but it is working with a red light, so the participants cannot suspect it.	Device: Testes shocker It is a device that give electric shocks (up to 5 milli Amperes) and it is designed to contain both the testes within it.

Arm

Intervention/Treatment

Active Comparator: Testes shocker

This device is working and giving the electrical shocks regularly.

Device: Testes shocker

It is a device that give electric shocks (up to 5 milli Amperes) and it is designed to contain both the testes within it.

Placebo Comparator: Fake Testes shocker

This device is not giving electricity but it is working with a red light, so the participants cannot suspect it.

Device: Testes shocker

It is a device that give electric shocks (up to 5 milli Amperes) and it is designed to contain both the testes within it.

Outcome Measures

Primary Outcome Measures

Semen analysis [4 months]
By taking the semen from the participants at baseline and then after each month and analyse it.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.