NCT05506722

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

August 17, 2022

Last Update Submit

October 31, 2022

Conditions

Keywords

InfertilityTestes shockerElectric shocks

Outcome Measures

Primary Outcomes (1)

  • Semen analysis

    By taking the semen from the participants at baseline and then after each month and analyse it.

    4 months

Study Arms (2)

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

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 shockerTestes shocker

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly those who consider themselves as males and have males genital organs of penis and testes were included.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Dar medical Center

Nasiriyah, Thi Qar, 64001, Iraq

RECRUITING

MeSH Terms

Conditions

Infertility, MaleOligospermiaAsthenozoospermiaInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Hashim Talib T Hashim, MBChB

    University of Baghdad, College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hashim Talib T Hashim, MBChB

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
By mixing the devices together and giving them to the participants blindly.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blinded two groups, one is the treated group and the other is the placebo group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor (MBChB)

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 18, 2022

Study Start

September 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

November 3, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations