Validation of New Devices Against Ambient Electromagnetic Radiation: A Randomized Double Blind Controlled Study
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Waveguard GmbH
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sperm concentration
Study Overview
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.
Detailed Description
Normal healthy men enrolled in the study will be asked to provide semen specimens prior to the use of device. Samples will be produced with a minimum of 48-72 hours of abstinence. Further, the subjects will be blindly assigned with either sham Qi-Shield or Qi-Shield device and will be instructed to use the device for a duration of 8 weeks .Semen samples will be provided by the subjects at 0, 4 and 8 weeks interval.
Group 1 study subjects will be provided with sham Qi-Shield device, whereas Group 2 study subjects with be provided with actual Qi-Shield device. Each user will be provided with a small carrier bag to accommodate the device during their travel. The participants are advised to keep the device within 3 meters of range as per the manufacturer instructions for a duration of 8 weeks.
Semen analysis All specimens will be collected by masturbation at the Andrology Laboratory after 48-72 hours of sexual abstinence. Samples will be allowed to liquefy completely for 15-20 minutes at 37C before further processing. After complete liquefaction, semen analysis will be carried out using automated LensHooke™X1 PRO semen quality analyzer (Bonraybio Co., Ltd) to determine sperm concentration and motility, progressive motility (Agarwal et al., 2019). Viability will be determined by Eosin-Nigrosin stain if motility is <25%. Smears of the raw semen will be stained with a Diff-Quik kit (Baxter Healthcare Corporation, Inc., McGaw Park, IL) for assessment of sperm morphology according to strict criteria as described in the WHO, 5th edition guideline.
White blood cell measurement When the round cell concentration in the ejaculate is >1 X million/mL or >5 round cells per high power field, the sample will be tested for leukocytospermia, i.e. >1 X million white blood cells/mL. This will be confirmed by the peroxidase or the Endtz test.
Measurement of Oxidation Reduction Potential ORP measures the transfer of electrons from a reductant (or antioxidant) to an oxidant. ORP is measured in millivolts (mV). In the current study, ORP will be measured using novel galvanostat-based technology-the MiOXSYS System (Aytu Bioscience, Englewood, CO). Briefly, 30µL of liquefied semen will be loaded on the MiOXSYS sensor. The sensor will be inserted into the MiOXSYS analyzer. Static ORP (sORP), measured in mV, is the integrated measure of the existing balance between total oxidants and reductants in a biological system. Data will be normalized with sperm concentration. ORP will be expressed as mV/ million sperm/mL.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Normal healthy men with normozoospermic semen parameters.
Exclusion Criteria
- •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
Arms & Interventions
Sham Qi-Shield user group
Intervention: sham device against ambient electromagnetic radiation (Device)
Qi-Shield user group
Intervention: new device against ambient electromagnetic radiation (Device)
Outcomes
Primary Outcomes
Sperm concentration
Time Frame: 8 weeks
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).
Seminal oxidative stress
Time Frame: 8 weeks
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.
Total sperm motility
Time Frame: 8 weeks
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).
Progressive motility
Time Frame: 8 weeks
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).
Sperm DNA damage
Time Frame: 8 weeks
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.
Sperm morphology
Time Frame: 8 weeks
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).
Sperm proteome
Time Frame: 8 weeks
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.
Sperm concentration
Time Frame: 0 weeks
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).
Sperm concentration
Time Frame: 4 weeks
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).
Total sperm motility
Time Frame: 0 weeks
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).
Total sperm motility
Time Frame: 4 weeks
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).
Progressive motility
Time Frame: 0 weeks
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).
Progressive motility
Time Frame: 4 weeks
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).
Sperm morphology
Time Frame: 0 weeks
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).
Sperm morphology
Time Frame: 4 weeks
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).
Seminal oxidative stress
Time Frame: 0 weeks
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.
Seminal oxidative stress
Time Frame: 4 weeks
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.
Sperm DNA damage
Time Frame: 0 weeks
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.
Sperm DNA damage
Time Frame: 4 weeks
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.
Sperm proteome
Time Frame: 0 weeks
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.
Sperm proteome
Time Frame: 4 weeks
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.
Secondary Outcomes
No secondary outcomes reported