NCT04541459

Brief Summary

Project Summary Cell phones have become indispensable devices in the investigator's daily life. These phones operate between 400 and 2000 MHz frequency bands and emit radiofrequency electromagnetic waves (EMW). Radio-frequency electro-magnetic field exposure from cell phones or other sources of microwaves have deleterious effects on sperm parameters (like sperm count, morphology, motility). Further, EMW radiation emitted by mobile phones affects cells and organelles, and results in disorientation of charged molecules within the cytosol and a distortion of electron flow along the internal membranes of the cells. These cellular changes results in the generation of ROS leading to oxidative stress, which in turn results in radiation-induced sperm DNA fragmentation. Radiation shield can help provide protection from high levels of EMW radiations deflecting, diverting, and absorbing the radiation between the user and the source. A new EMW radiation shield, Qi-Shield device developed by Waveguard GmbH (Bautzen, Germany) provides protection against the radiations emitted by the smartphone and laptop devices. Qi-Shield utilizes conductive fluids in a particular geometric arrangement intended to ameliorate the negative effects of EMW radiation. Study Aims: To evaluate the changes in the semen parameters from the use of Qi-Shield device in sham (control) and user groups To determine the molecular changes pertaining to sperm proteins from the use of Qi-Shield device in sham (control) and user groups Significance The negative health consequences of EMWs have been documented across a wide range of device types, exposure frequencies and doses (Giuliani, 2010), at field strengths substantially below the International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines for permissible exposures. In the absence of a revision in the ICNIRP guidelines, near-term public exposures to EMWs will most certainly continue to increase, despite the scientific evidence suggesting more careful review and recommendations to limit exposure to electromagnetic fields as much as possible. At present, there is no veritable means for counteracting the negative health consequences of human-made EMWs, revealing an unmet need for a means of protecting from or ameliorating the negative effects of EMWs, and the need for devising strategies for creating safer living and working environments in a time of increasing EMW exposures. Positive results in this study would demonstrate a means of counteracting negative effects on human sperm due to EMWs. Documentation of protection due to the Qi-Shield devices would show proof of principle that a low-cost passive device, portable and without battery or mains power, can provide improvements in human sperm parameters, with promise for a means of counteracting EMW-reduced fertility in large numbers of people. Confirmation of changes on protein expression would provide data needed to identify specific pathways of action, insight that is necessary for a more detailed understanding of the mechanisms of action of the EMW protection effect. Taken together, these results would suggest further lines of study in EMW protection, and provide clinical support for the adoption of EMW-protecting devices in the home and workplace.

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
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2020

Shorter than P25 for early_phase_1

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 27, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

August 27, 2020

Last Update Submit

October 5, 2020

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (21)

  • Sperm concentration

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Sperm concentration (millions/ mL) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    0 weeks

  • Sperm concentration

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Sperm concentration (millions/ mL) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    4 weeks

  • Sperm concentration

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Sperm concentration (millions/ mL) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    8 weeks

  • Total sperm motility

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Total motility (%) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    0 weeks

  • Total sperm motility

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Total motility (%) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    4 weeks

  • Total sperm motility

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Total motility (%) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    8 weeks

  • Progressive motility

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Progressive motility (%) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    0 weeks

  • Progressive motility

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Progressive motility (%) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    4 weeks

  • Progressive motility

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Progressive motility (%) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    8 weeks

  • Sperm morphology

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Sperm morphology (%) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    0 weeks

  • Sperm morphology

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Sperm morphology (%) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    4 weeks

  • Sperm morphology

    Semen analysis will be carried out using LensHooke™X1 PRO semen quality analyzer. Sperm morphology (%) will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group).

    8 weeks

  • Seminal oxidative stress

    ORP is considered as a marker of oxidative stress. Increased levels of oxidative stress is harmful to the spermatozoa. In semen samples ORP is measured using MiOXSYS analyzers. Seminal ORP will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group) to evaluate the change in the seminal oxidative stress due to use of Qi-shield.

    0 weeks

  • Seminal oxidative stress

    ORP is considered as a marker of oxidative stress. Increased levels of oxidative stress is harmful to the spermatozoa. In semen samples ORP is measured using MiOXSYS analyzers. Seminal ORP will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group) to evaluate the change in the seminal oxidative stress due to use of Qi-shield.

    4 weeks

  • Seminal oxidative stress

    ORP is considered as a marker of oxidative stress. Increased levels of oxidative stress is harmful to the spermatozoa. In semen samples ORP is measured using MiOXSYS analyzers. Seminal ORP will be assessed in both the groups (Qi-shield user group and sham Qi-shield user group) to evaluate the change in the seminal oxidative stress due to use of Qi-shield.

    8 weeks

  • Sperm DNA damage

    Sperm DNA integrity is directly correlated with the quality of the spermatozoa. Increased levels of sperm DNA damage has negative impact on pregnancy and live birth rates. Sperm DNA fragmentation (SDF) is measured using TUNEL assay. In the current study levels of SDF before and after the use of Qi-shield will allow us to understand the effect of electromagnetic radiations on DNA integrity of spermatozoa.

    0 weeks

  • Sperm DNA damage

    Sperm DNA integrity is directly correlated with the quality of the spermatozoa. Increased levels of sperm DNA damage has negative impact on pregnancy and live birth rates. Sperm DNA fragmentation (SDF) is measured using TUNEL assay. In the current study levels of SDF before and after the use of Qi-shield will allow us to understand the effect of electromagnetic radiations on DNA integrity of spermatozoa.

    4 weeks

  • Sperm DNA damage

    Sperm DNA integrity is directly correlated with the quality of the spermatozoa. Increased levels of sperm DNA damage has negative impact on pregnancy and live birth rates. Sperm DNA fragmentation (SDF) is measured using TUNEL assay. In the current study levels of SDF before and after the use of Qi-shield will allow us to understand the effect of electromagnetic radiations on DNA integrity of spermatozoa.

    8 weeks

  • Sperm proteome

    In spermatozoa normal expression of fertility associated proteins are essential for fertilization process. Several studies reported that aberrant expression of proteins related to sperm function as capacitation, hyperactivation, acrosome reaction and binging of zona pellucida with ovum in infertile men. Furthermore, electromagnetic radiations can also cause molecular changes. In the present study, proteome profile of the spermatozoa from subjects before and after the use of Qi-shield will provide the information related to the molecular changes at protein level.

    0 weeks

  • Sperm proteome

    In spermatozoa normal expression of fertility associated proteins are essential for fertilization process. Several studies reported that aberrant expression of proteins related to sperm function as capacitation, hyperactivation, acrosome reaction and binging of zona pellucida with ovum in infertile men. Furthermore, electromagnetic radiations can also cause molecular changes. In the present study, proteome profile of the spermatozoa from subjects before and after the use of Qi-shield will provide the information related to the molecular changes at protein level.

    4 weeks

  • Sperm proteome

    In spermatozoa normal expression of fertility associated proteins are essential for fertilization process. Several studies reported that aberrant expression of proteins related to sperm function as capacitation, hyperactivation, acrosome reaction and binging of zona pellucida with ovum in infertile men. Furthermore, electromagnetic radiations can also cause molecular changes. In the present study, proteome profile of the spermatozoa from subjects before and after the use of Qi-shield will provide the information related to the molecular changes at protein level.

    8 weeks

Study Arms (2)

Sham Qi-Shield user group

SHAM COMPARATOR
Device: sham device against ambient electromagnetic radiation

Qi-Shield user group

ACTIVE COMPARATOR
Device: new device against ambient electromagnetic radiation

Interventions

new device against ambient electromagnetic radiationDEVICE

New device provides protection against the radiations emitted by the smartphone and laptop devices. Device uses conductive fluids in a particular geometric arrangement intended to ameliorate the negative effects of EMW radiation.

Qi-Shield user group
sham device against ambient electromagnetic radiationDEVICE

Sham device as as a control for new device, which provides protection against the radiations emitted by the smartphone and laptop devices. Device uses conductive fluids in a particular geometric arrangement intended to ameliorate the negative effects of EMW radiation.

Sham Qi-Shield user group

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale subjects, normozoospermic healthy donors.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal healthy men with normozoospermic semen parameters.

You may not qualify if:

  • Subjects with a history of smoking
  • Chewing tobacco
  • Alcohol consumption
  • Antioxidant supplementation
  • Orchitis, varicocele, tuberculosis, diabetes mellitus, and hypertension
  • Viral/bacterial infection in the past 4 weeks
  • History of cardiac, neural, or nephrotic disease
  • Family history of any genetic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Center for Reproductive Medicine, Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (6)

  • Agarwal A, Deepinder F, Sharma RK, Ranga G, Li J. Effect of cell phone usage on semen analysis in men attending infertility clinic: an observational study. Fertil Steril. 2008 Jan;89(1):124-8. doi: 10.1016/j.fertnstert.2007.01.166. Epub 2007 May 4.

    PMID: 17482179BACKGROUND

  • Agarwal A, Desai NR, Makker K, Varghese A, Mouradi R, Sabanegh E, Sharma R. Effects of radiofrequency electromagnetic waves (RF-EMW) from cellular phones on human ejaculated semen: an in vitro pilot study. Fertil Steril. 2009 Oct;92(4):1318-1325. doi: 10.1016/j.fertnstert.2008.08.022. Epub 2008 Sep 20.

    PMID: 18804757BACKGROUND

  • Agarwal A, Henkel R, Huang CC, Lee MS. Automation of human semen analysis using a novel artificial intelligence optical microscopic technology. Andrologia. 2019 Dec;51(11):e13440. doi: 10.1111/and.13440. Epub 2019 Oct 4.

    PMID: 31583732BACKGROUND

  • Desai NR, Kesari KK, Agarwal A. Pathophysiology of cell phone radiation: oxidative stress and carcinogenesis with focus on male reproductive system. Reprod Biol Endocrinol. 2009 Oct 22;7:114. doi: 10.1186/1477-7827-7-114.

    PMID: 19849853BACKGROUND

  • Kesari KK, Agarwal A, Henkel R. Radiations and male fertility. Reprod Biol Endocrinol. 2018 Dec 9;16(1):118. doi: 10.1186/s12958-018-0431-1.

    PMID: 30445985BACKGROUND

  • Kivrak EG, Yurt KK, Kaplan AA, Alkan I, Altun G. Effects of electromagnetic fields exposure on the antioxidant defense system. J Microsc Ultrastruct. 2017 Oct-Dec;5(4):167-176. doi: 10.1016/j.jmau.2017.07.003. Epub 2017 Aug 2.

    PMID: 30023251BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Ashok Agarwal, PhD

    American Center for Reproductive Medicine, Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashok Agarwal, PhD

CONTACT

+1(216) 444-9485agarwaa@ccf.org

Manesh K Panner Selvam, PhD

CONTACT

+1(216) 414-9207pannerm@ccf.org

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised double blind controlled study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

September 9, 2020

Study Start

September 14, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)