Infertility, MaleCOVInfertilityNCT05421234
Effect of COVID-19 on Platelet Mitochondrial Bioenergetic, Antioxidants and Oxidative Stress in Infertile Men.
A study testing diagnostic test and sperm analysis in people with Infertility, Male and COVID-19, run by Comenius University at 1 site in Slovakia.
Trial summary
To verify the hypothesis that infertility and the effect of SARS-CoV-2 on infertility may damage platelet mitochondrial bioenergetics and endogenous coenzyme Q10 levels in infertile men. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male, COVID-19
- What is being tested?
- diagnostic test and sperm analysis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Apr 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile patients without COVID-19
- Infertile patients after COVID-19 Control group: healthy volunteers
Who cannot join
- disagreement with informed consent
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Pharmacobiochemical Laboratory of Third Department of Internal Medicine, Faculty of Medicine Comenius University in Bratislava
Bratislava, 81108
About this study
Official title: Effect of COVID-19 on Spermiogram, Platelet Mitochondrial Bioenergetic, Antioxidants and Oxidative Stress in Infertile Men
To verify the hypothesis that infertility and the effect of SARS-CoV-2 on infertility may damage platelet mitochondrial bioenergetics and endogenous coenzyme Q10 levels in infertile men.
Read the detailed description
Infertility is defined as the failure of the reproductive system to achieve pregnancy after 12 months of unprotected sex life. The pathobiochemical mechanisms of male fertility disorders include reduced sperm motility and quality, oxidative stress, reduced antioxidant capacity, mtDNA fragmentation, and sperm mitochondrial dysfunction.
Sperm contain a number of mitochondria that are spirally arranged around the middle part of the axomen. The main role of mitochondria in spermatozoa is to generate the energy needed for their motility (1, 2). Endogenous sources - coenzyme Q10 and carnitine - are key for energy production (ATP) in sperm mitochondria. Physiological functions of sperm require a minimal amount of reactive oxygen species (ROS), but uncontrolled ROS production contributes to reduced motility and sperm count, fragmentation of mtDNA (3).
In recent years, blood cells (platelets, lymphocytes and monocytes) have been used to diagnose mitochondrial disorders. Isolated peripheral blood platelets are an available source of mitochondria to assess mitochondrial health. Platelets receive energy mainly through glycolysis and oxidative phosphorylation. Platelet mitochondrial dysfunction has been demonstrated in patients with chronic kidney disease (4, 5), in patients with rheumatoid arthritis (6), in patients with acute COVID-19 (7). An O2k-respirometer (Oroboros, Austria) (8, 9) is used for respirometric analysis of platelet mitochondrial bioenergetics.
None information is available on the effect of infertility on platelet mitochondrial function, none on the effect of SARS-CoV-2 on platelet mitochondrial function in infertile patients, or the effect of vaccination on sperm function. Testicular damage and subsequent infertility due to SARS-CoV infection is expected. -2, directly via SARS-CoV-2 binding to ACE2 receptors or secondarily, in relation to the immunological and inflammatory response (10). SARS-CoV-2 virus induces excessive production of pro-inflammatory cytokines, mainly interleukin 6 (IL6), interleukin-1β (IL-1β) and tumor necrosis factor α (TNFα). Cytokines can impair sperm movement and reduce sperm count. High levels of pro-inflammatory cytokines have been found in infertile men (with oligozoospermia, asthenozoospermia, teratozoospermia) (11).
SARS-CoV-2 virus can manipulate mitochondrial function in patients with post-COVID-19 syndrome, which may persist for a long time (12). In previous our study the investigators found modulation of platelet mitochondrial respiration, reduction ATP production via oxidative phosphorylation, reduces endogenous coenzyme Q10 production, reprogramming of cellular metabolism patients after 4-7 weeks overcoming acute COVID-19, SARS-CoV-2 (7). In another studies the investigators confirmed platelet mitochondrial bioenergetic deficiency, reduced endogenous coenzyme Q10 production in patients with post-COVID-19 syndrome, 3-6 months after overcoming COVID-19 (13, 14, 15). Results of this study contribute to the understanding of the pathobiochemical mechanisms of infertility on subcellular level and to verify the hypothesis that infertility and the effect of SARS-CoV-2 on infertility may affect platelet mitochondrial bioenergetics and endogenous coenzyme Q10 levels.
- Conditions
- Infertility, Male, COVID-19
- Being tested
- diagnostic test and sperm analysis
- Keywords
- men infertility, after-COVID-19, platelets, mitochondrial bioenergetics, coenzyme Q10, oxidative stress
- Medical subject headings
- Infertility, Male, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic test and sperm analysisOther
Diagnostic Test: 2x14 ml of peripheral blood collected in the tube with anticoagulant, for platelet isolation, respirometry mitochondrial analysis, antioxidants (coenzyme Q10, vitamin E, gamma-tocopherol, beta-carotene) and TBARS estimation.
Sperm analysis: standard spermiogram examination (volume, pH, number, motility and pathology) in the broker chamber, as well as extended examinations: mioxsys for redox potential, Vitalsperm (eosin-nigrosine staining) for sperm vitality and anti-sperm antibody (IgG) test.
| Study group | Role | What they receive |
|---|---|---|
| infertile men with post-COVID-19 (vaccinated or without vaccination) | Active comparator | 15 infertile men with post-COVID-19 (vaccinated or without vaccination) Receives: Other: diagnostic test and sperm analysis |
| infertile men without post-COVID-19 (vaccinated or without vaccination) | Active comparator | 15 infertile men without post-COVID-19 (vaccinated or without vaccination) Receives: Other: diagnostic test and sperm analysis |
| Control: 15 healthy men volunteers (no COVID-19, no other pathologies) | Active comparator | 15 healthy men volunteers (no COVID-19, no other pathologies) as control group Receives: Other: diagnostic test and sperm analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms
Clinical symptoms: infertile patients without COVID-19 (vaccinated, or none vaccinated) Clinical symptoms patients after COVID-19
Measured: 15 minutes
Damaged platelet mitochondrial bioenergetics 1
Basal oxygen consumption rate in intact platelets (ce)
Measured: 1 day
Damaged platelet mitochondrial bioenergetics 2
rate of mitochondria LEAK respiration with CI-linked substrates (1PM - state 4)
Measured: 1 day
Damaged platelet mitochondrial bioenergetics 3
CI-linked respiration coupled with ATPproduction (2D-CI-linked oxidative phosphorylation capacity), respiration after addition of cytochrome c (2C).
Measured: 1 day
Damaged platelet mitochondrial bioenergetics 4
Maximal oxidative capacity (the electron transfer capacity -ET), after uncoupler titration (3U).
Measured: 1 day
Damaged platelet mitochondrial bioenergetics 5
After addition of exogenous substrate glutamate (4G) non-coupled mitochondrial oxygen consumption.
Measured: 1 day
Damaged platelet mitochondrial bioenergetics 6
Non-coupled oxygen consumption with CI\&CII-linked substrate (5S) improvement of mitochondrial parameters representing OXPHOS- and electron tranport capacity (ET-capacity).
Measured: 1 day
Endogenous coenzyme Q10-TOTAL 1
CoQ10-TOTAL in: Platelets (pmol.10-9 cells)
Measured: 1 day
Endogenous coenzyme Q10-TOTAL 2
CoQ10-TOTAL in: Blood (µmol.L-1)
Measured: 1 day
Endogenous coenzyme Q10-TOTAL 3
CoQ10-TOTAL in: Plasma (µmol.L-1)
Measured: 1 day
Endogenous coenzyme TBARS
Endogenous concentration of CoQ10-TOTAL (ubiquinone + ubiquinol) in platelets, blood and plasma CoQ10-TOTAL in: TBARS in plasma (µmol.L-1).
Measured: 1 day
Sperm analysis 1
standard spermiogram examination (volume, pH, number, motility and pathology) in the broker chamber
Measured: 1 day
Sperm analysis 2
mioxsys for redox potential
Measured: 1 day
Sperm analysis 3
Vitalsperm (eosin-nigrosine staining) for sperm vitality
Measured: 1 day
Sperm analysis 4
anti-sperm antibody (IgG) test
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Collaborators
- GYN-FIV
- Responsible party
- Sponsor
- Investigators
- Anna Gvozdjáková, Prof.Dr.DSc., Principal investigator, CU in Bratislava, Faculty of Medicine, Pharmacobiochemical Laboratory of 3rd department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421234
- Sponsor's protocol ID
- COVID-19-INFERTILITY-SK01/2022
- Acronym
- COVInfertility
- Status last verified
- Jan 2022
- First submitted
- 15 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sheweita SA, Tilmisany AM, Al-Sawaf H. Mechanisms of male infertility: role of antioxidants. Curr Drug Metab. 2005 Oct;6(5):495-501. doi: 10.2174/138920005774330594.
PubMed 16248841Gvozdjakova A, Kucharska J, Dubravicky J, Mojto V, Singh RB. Coenzyme Q(1)(0), alpha-tocopherol, and oxidative stress could be important metabolic biomarkers of male infertility. Dis Markers. 2015;2015:827941. doi: 10.1155/2015/827941. Epub 2015 Feb 25.
PubMed 25810566Gvozdjakova A, Sumbalova Z, Kucharska J, Chladekova A, Rausova Z, Vancova O, Komlosi M, Ulicna O, Mojto V. Platelet mitochondrial bioenergetic analysis in patients with nephropathies and non-communicable diseases: a new method. Bratisl Lek Listy. 2019;120(9):630-635. doi: 10.4149/BLL_2019_104.
PubMed 31475544Gvozdjakova A, Sumbalova Z, Kucharska J, Komlosi M, Rausova Z, Vancova O, Szamosova M, Mojto V. Platelet Mitochondrial Respiration, Endogenous Coenzyme Q10 and Oxidative Stress in Patients with Chronic Kidney Disease. Diagnostics (Basel). 2020 Mar 23;10(3):176. doi: 10.3390/diagnostics10030176.
PubMed 32210203Gvozdjakova A, Sumbalova Z, Kucharska J, Szamosova M, Capova L, Rausova Z, Vancova O, Mojto V, Langsjoen P, Palacka P. Platelet mitochondrial respiration and coenzyme Q10 could be used as new diagnostic strategy for mitochondrial dysfunction in rheumatoid diseases. PLoS One. 2021 Sep 28;16(9):e0256135. doi: 10.1371/journal.pone.0256135. eCollection 2021.
PubMed 34582480Sumbalova Z, Kucharska J, Palacka P, Rausova Z, Langsjoen PH, Langsjoen AM, Gvozdjakova A. Platelet mitochondrial function and endogenous coenzyme Q10 levels are reduced in patients after COVID-19. Bratisl Lek Listy. 2022;123(1):9-15. doi: 10.4149/BLL_2022_002.
PubMed 34967652Pesta D, Gnaiger E. High-resolution respirometry: OXPHOS protocols for human cells and permeabilized fibers from small biopsies of human muscle. Methods Mol Biol. 2012;810:25-58. doi: 10.1007/978-1-61779-382-0_3.
PubMed 22057559Abobaker A, Raba AA. Does COVID-19 affect male fertility? World J Urol. 2021 Mar;39(3):975-976. doi: 10.1007/s00345-020-03208-w. Epub 2020 Apr 21. No abstract available.
PubMed 32318855Rajak P, Roy S, Dutta M, Podder S, Sarkar S, Ganguly A, Mandi M, Khatun S. Understanding the cross-talk between mediators of infertility and COVID-19. Reprod Biol. 2021 Dec;21(4):100559. doi: 10.1016/j.repbio.2021.100559. Epub 2021 Sep 1.
PubMed 34547545Gvozdjakova A, Klauco F, Kucharska J, Sumbalova Z. Is mitochondrial bioenergetics and coenzyme Q10 the target of a virus causing COVID-19? Bratisl Lek Listy. 2020;121(11):775-778. doi: 10.4149/BLL_2020_126.
PubMed 33164536Boguenet M, Bouet PE, Spiers A, Reynier P, May-Panloup P. Mitochondria: their role in spermatozoa and in male infertility. Hum Reprod Update. 2021 Jun 22;27(4):697-719. doi: 10.1093/humupd/dmab001.
PubMed 33555313Khalili MA, Leisegang K, Majzoub A, Finelli R, Panner Selvam MK, Henkel R, Mojgan M, Agarwal A. Male Fertility and the COVID-19 Pandemic: Systematic Review of the Literature. World J Mens Health. 2020 Oct;38(4):506-520. doi: 10.5534/wjmh.200134. Epub 2020 Aug 14.
PubMed 32814369
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COVID-19 on Spermiogram, Platelet Mitochondrial Bioenergetic, Antioxidants and Oxidative Stress in Infertile Men
- ClinicalTrials.gov ID
- NCT05421234
- Acronym / sponsor ID
- COVInfertility / COVID-19-INFERTILITY-SK01/2022
- Conditions
- Infertility, Male, COVID-19
- Keywords
- men infertility, after-COVID-19, platelets, mitochondrial bioenergetics, coenzyme Q10, oxidative stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Collaborators
- GYN-FIV
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To verify the hypothesis that infertility and the effect of SARS-CoV-2 on infertility may damage platelet mitochondrial bioenergetics and endogenous coenzyme Q10 levels in infertile men.
Detailed description
Infertility is defined as the failure of the reproductive system to achieve pregnancy after 12 months of unprotected sex life. The pathobiochemical mechanisms of male fertility disorders include reduced sperm motility and quality, oxidative stress, reduced antioxidant capacity, mtDNA fragmentation, and sperm mitochondrial dysfunction.
Sperm contain a number of mitochondria that are spirally arranged around the middle part of the axomen. The main role of mitochondria in spermatozoa is to generate the energy needed for their motility (1, 2). Endogenous sources - coenzyme Q10 and carnitine - are key for energy production (ATP) in sperm mitochondria. Physiological functions of sperm require a minimal amount of reactive oxygen species (ROS), but uncontrolled ROS production contributes to reduced motility and sperm count, fragmentation of mtDNA (3).
In recent years, blood cells (platelets, lymphocytes and monocytes) have been used to diagnose mitochondrial disorders. Isolated peripheral blood platelets are an available source of mitochondria to assess mitochondrial health. Platelets receive energy mainly through glycolysis and oxidative phosphorylation. Platelet mitochondrial dysfunction has been demonstrated in patients with chronic kidney disease (4, 5), in patients with rheumatoid arthritis (6), in patients with acute COVID-19 (7). An O2k-respirometer (Oroboros, Austria) (8, 9) is used for respirometric analysis of platelet mitochondrial bioenergetics.
None information is available on the effect of infertility on platelet mitochondrial function, none on the effect of SARS-CoV-2 on platelet mitochondrial function in infertile patients, or the effect of vaccination on sperm function. Testicular damage and subsequent infertility due to SARS-CoV infection is expected. -2, directly via SARS-CoV-2 binding to ACE2 receptors or secondarily, in relation to the immunological and inflammatory response (10). SARS-CoV-2 virus induces excessive production of pro-inflammatory cytokines, mainly interleukin 6 (IL6), interleukin-1β (IL-1β) and tumor necrosis factor α (TNFα). Cytokines can impair sperm movement and reduce sperm count. High levels of pro-inflammatory cytokines have been found in infertile men (with oligozoospermia, asthenozoospermia, teratozoospermia) (11).
SARS-CoV-2 virus can manipulate mitochondrial function in patients with post-COVID-19 syndrome, which may persist for a long time (12). In previous our study the investigators found modulation of platelet mitochondrial respiration, reduction ATP production via oxidative phosphorylation, reduces endogenous coenzyme Q10 production, reprogramming of cellular metabolism patients after 4-7 weeks overcoming acute COVID-19, SARS-CoV-2 (7). In another studies the investigators confirmed platelet mitochondrial bioenergetic deficiency, reduced endogenous coenzyme Q10 production in patients with post-COVID-19 syndrome, 3-6 months after overcoming COVID-19 (13, 14, 15). Results of this study contribute to the understanding of the pathobiochemical mechanisms of infertility on subcellular level and to verify the hypothesis that infertility and the effect of SARS-CoV-2 on infertility may affect platelet mitochondrial bioenergetics and endogenous coenzyme Q10 levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| infertile men with post-COVID-19 (vaccinated or without vaccination) | Active comparator | Other: diagnostic test and sperm analysis15 infertile men with post-COVID-19 (vaccinated or without vaccination) |
| infertile men without post-COVID-19 (vaccinated or without vaccination) | Active comparator | Other: diagnostic test and sperm analysis15 infertile men without post-COVID-19 (vaccinated or without vaccination) |
| Control: 15 healthy men volunteers (no COVID-19, no other pathologies) | Active comparator | Other: diagnostic test and sperm analysis15 healthy men volunteers (no COVID-19, no other pathologies) as control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertile patients without COVID-19
- Infertile patients after COVID-19 Control group: healthy volunteers
Key exclusion criteria (1 listed)
- disagreement with informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic test and sperm analysisDiagnostic Test: 2x14 ml of peripheral blood collected in the tube with anticoagulant, for platelet isolation, respirometry mitochondrial analysis, antioxidants (coenzyme Q10, vitamin E, gamma-tocopherol, beta-carotene) and TBARS estimation. Sperm analysis: standard spermiogram examination (volume, pH, number, motility and pathology) in the broker chamber, as well as extended examinations: mioxsys for redox potential, Vitalsperm (eosin-nigrosine staining) for sperm vitality and anti-sperm antibody (IgG) test. | Other | Control: 15 healthy men volunteers (no COVID-19, no other pathologies), infertile men with post-COVID-19 (vaccinated or without vaccination), infertile men without post-COVID-19 (vaccinated or without vaccination) |
Primary outcome
Clinical symptoms
Time frame: 15 minutes
Clinical symptoms: infertile patients without COVID-19 (vaccinated, or none vaccinated) Clinical symptoms patients after COVID-19
Damaged platelet mitochondrial bioenergetics 1
Time frame: 1 day
Basal oxygen consumption rate in intact platelets (ce)
Damaged platelet mitochondrial bioenergetics 2
Time frame: 1 day
rate of mitochondria LEAK respiration with CI-linked substrates (1PM - state 4)
Damaged platelet mitochondrial bioenergetics 3
Time frame: 1 day
CI-linked respiration coupled with ATPproduction (2D-CI-linked oxidative phosphorylation capacity), respiration after addition of cytochrome c (2C).
Damaged platelet mitochondrial bioenergetics 4
Time frame: 1 day
Maximal oxidative capacity (the electron transfer capacity -ET), after uncoupler titration (3U).
Damaged platelet mitochondrial bioenergetics 5
Time frame: 1 day
After addition of exogenous substrate glutamate (4G) non-coupled mitochondrial oxygen consumption.
Damaged platelet mitochondrial bioenergetics 6
Time frame: 1 day
Non-coupled oxygen consumption with CI\&CII-linked substrate (5S) improvement of mitochondrial parameters representing OXPHOS- and electron tranport capacity (ET-capacity).
Endogenous coenzyme Q10-TOTAL 1
Time frame: 1 day
CoQ10-TOTAL in: Platelets (pmol.10-9 cells)
Endogenous coenzyme Q10-TOTAL 2
Time frame: 1 day
CoQ10-TOTAL in: Blood (µmol.L-1)
Endogenous coenzyme Q10-TOTAL 3
Time frame: 1 day
CoQ10-TOTAL in: Plasma (µmol.L-1)
Endogenous coenzyme TBARS
Time frame: 1 day
Endogenous concentration of CoQ10-TOTAL (ubiquinone + ubiquinol) in platelets, blood and plasma CoQ10-TOTAL in: TBARS in plasma (µmol.L-1).
Sperm analysis 1
Time frame: 1 day
standard spermiogram examination (volume, pH, number, motility and pathology) in the broker chamber
Sperm analysis 2
Time frame: 1 day
mioxsys for redox potential
Sperm analysis 3
Time frame: 1 day
Vitalsperm (eosin-nigrosine staining) for sperm vitality
Sperm analysis 4
Time frame: 1 day
anti-sperm antibody (IgG) test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Results publication: PubMed 16248841Sheweita SA, Tilmisany AM, Al-Sawaf H. Mechanisms of male infertility: role of antioxidants. Curr Drug Metab. 2005 Oct;6(5):495-501. doi: 10.2174/138920005774330594.
- Results publication: PubMed 25810566Gvozdjakova A, Kucharska J, Dubravicky J, Mojto V, Singh RB. Coenzyme Q(1)(0), alpha-tocopherol, and oxidative stress could be important metabolic biomarkers of male infertility. Dis Markers. 2015;2015:827941. doi: 10.1155/2015/827941. Epub 2015 Feb 25.
- Results publication: PubMed 31475544Gvozdjakova A, Sumbalova Z, Kucharska J, Chladekova A, Rausova Z, Vancova O, Komlosi M, Ulicna O, Mojto V. Platelet mitochondrial bioenergetic analysis in patients with nephropathies and non-communicable diseases: a new method. Bratisl Lek Listy. 2019;120(9):630-635. doi: 10.4149/BLL_2019_104.
- Results publication: PubMed 32210203Gvozdjakova A, Sumbalova Z, Kucharska J, Komlosi M, Rausova Z, Vancova O, Szamosova M, Mojto V. Platelet Mitochondrial Respiration, Endogenous Coenzyme Q10 and Oxidative Stress in Patients with Chronic Kidney Disease. Diagnostics (Basel). 2020 Mar 23;10(3):176. doi: 10.3390/diagnostics10030176.
- Results publication: PubMed 34582480Gvozdjakova A, Sumbalova Z, Kucharska J, Szamosova M, Capova L, Rausova Z, Vancova O, Mojto V, Langsjoen P, Palacka P. Platelet mitochondrial respiration and coenzyme Q10 could be used as new diagnostic strategy for mitochondrial dysfunction in rheumatoid diseases. PLoS One. 2021 Sep 28;16(9):e0256135. doi: 10.1371/journal.pone.0256135. eCollection 2021.
- Results publication: PubMed 34967652Sumbalova Z, Kucharska J, Palacka P, Rausova Z, Langsjoen PH, Langsjoen AM, Gvozdjakova A. Platelet mitochondrial function and endogenous coenzyme Q10 levels are reduced in patients after COVID-19. Bratisl Lek Listy. 2022;123(1):9-15. doi: 10.4149/BLL_2022_002.
- Results publication: PubMed 22057559Pesta D, Gnaiger E. High-resolution respirometry: OXPHOS protocols for human cells and permeabilized fibers from small biopsies of human muscle. Methods Mol Biol. 2012;810:25-58. doi: 10.1007/978-1-61779-382-0_3.
- Results publication: PubMed 32318855Abobaker A, Raba AA. Does COVID-19 affect male fertility? World J Urol. 2021 Mar;39(3):975-976. doi: 10.1007/s00345-020-03208-w. Epub 2020 Apr 21. No abstract available.
- Results publication: PubMed 34547545Rajak P, Roy S, Dutta M, Podder S, Sarkar S, Ganguly A, Mandi M, Khatun S. Understanding the cross-talk between mediators of infertility and COVID-19. Reprod Biol. 2021 Dec;21(4):100559. doi: 10.1016/j.repbio.2021.100559. Epub 2021 Sep 1.
- Results publication: PubMed 33164536Gvozdjakova A, Klauco F, Kucharska J, Sumbalova Z. Is mitochondrial bioenergetics and coenzyme Q10 the target of a virus causing COVID-19? Bratisl Lek Listy. 2020;121(11):775-778. doi: 10.4149/BLL_2020_126.
- Results publication: PubMed 33555313Boguenet M, Bouet PE, Spiers A, Reynier P, May-Panloup P. Mitochondria: their role in spermatozoa and in male infertility. Hum Reprod Update. 2021 Jun 22;27(4):697-719. doi: 10.1093/humupd/dmab001.
- Results publication: PubMed 32814369Khalili MA, Leisegang K, Majzoub A, Finelli R, Panner Selvam MK, Henkel R, Mojgan M, Agarwal A. Male Fertility and the COVID-19 Pandemic: Systematic Review of the Literature. World J Mens Health. 2020 Oct;38(4):506-520. doi: 10.5534/wjmh.200134. Epub 2020 Aug 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Gvozdjáková, Prof.Dr.DSc. principal investigator
CU in Bratislava, Faculty of Medicine, Pharmacobiochemical Laboratory of 3rd department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic test and sperm analysis in people with Infertility, Male and COVID-19, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical symptoms (time frame: 15 minutes). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05421234, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.