NCT05421234

Brief 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.

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

June 22, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

June 15, 2022

Last Update Submit

June 16, 2022

Conditions

Infertility, MaleCOVID-19

Keywords

men infertilityafter-COVID-19plateletsmitochondrial bioenergeticscoenzyme Q10oxidative stress

Outcome Measures

Primary Outcomes (15)

  • Clinical symptoms

    Clinical symptoms: infertile patients without COVID-19 (vaccinated, or none vaccinated) Clinical symptoms patients after COVID-19

    15 minutes

  • Damaged platelet mitochondrial bioenergetics 1

    Basal oxygen consumption rate in intact platelets (ce)

    1 day

  • Damaged platelet mitochondrial bioenergetics 2

    rate of mitochondria LEAK respiration with CI-linked substrates (1PM - state 4)

    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).

    1 day

  • Damaged platelet mitochondrial bioenergetics 4

    Maximal oxidative capacity (the electron transfer capacity -ET), after uncoupler titration (3U).

    1 day

  • Damaged platelet mitochondrial bioenergetics 5

    After addition of exogenous substrate glutamate (4G) non-coupled mitochondrial oxygen consumption.

    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).

    1 day

  • Endogenous coenzyme Q10-TOTAL 1

    CoQ10-TOTAL in: Platelets (pmol.10-9 cells)

    1 day

  • Endogenous coenzyme Q10-TOTAL 2

    CoQ10-TOTAL in: Blood (µmol.L-1)

    1 day

  • Endogenous coenzyme Q10-TOTAL 3

    CoQ10-TOTAL in: Plasma (µmol.L-1)

    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).

    1 day

  • Sperm analysis 1

    standard spermiogram examination (volume, pH, number, motility and pathology) in the broker chamber

    1 day

  • Sperm analysis 2

    mioxsys for redox potential

    1 day

  • Sperm analysis 3

    Vitalsperm (eosin-nigrosine staining) for sperm vitality

    1 day

  • Sperm analysis 4

    anti-sperm antibody (IgG) test

    1 day

Study Arms (3)

infertile men with post-COVID-19 (vaccinated or without vaccination)

ACTIVE COMPARATOR

15 infertile men with post-COVID-19 (vaccinated or without vaccination)

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)

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

Other: diagnostic test and sperm analysis

Interventions

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.

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)

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly men have sperm.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile patients without COVID-19
  • Infertile patients after COVID-19 Control group: healthy volunteers

You may not qualify if:

  • disagreement with informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmacobiochemical Laboratory of Third Department of Internal Medicine, Faculty of Medicine Comenius University in Bratislava

Bratislava, 81108, Slovakia

Location

Related Publications (12)

  • 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.

    PMID: 16248841RESULT

  • Gvozdjakova 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.

    PMID: 25810566RESULT

  • Gvozdjakova 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.

    PMID: 31475544RESULT

  • Gvozdjakova 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.

    PMID: 32210203RESULT

  • Gvozdjakova 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.

    PMID: 34582480RESULT

  • Sumbalova 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.

    PMID: 34967652RESULT

  • Pesta 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.

    PMID: 22057559RESULT

  • Abobaker 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.

    PMID: 32318855RESULT

  • Rajak 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.

    PMID: 34547545RESULT

  • Gvozdjakova 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.

    PMID: 33164536RESULT

  • Boguenet 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.

    PMID: 33555313RESULT

  • Khalili 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.

    PMID: 32814369RESULT

MeSH Terms

Conditions

Infertility, MaleCOVID-19

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Anna Gvozdjáková, Prof.Dr.DSc.

    CU in Bratislava, Faculty of Medicine, Pharmacobiochemical Laboratory of 3rd department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 16, 2022

Study Start

April 1, 2022

Primary Completion

December 31, 2022

Study Completion

March 30, 2023

Last Updated

June 22, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)