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Impact of the Coronavirus Disease 2019 (COVID-19) on Sperm Parameters

Impact of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection on the Sperm Parameters of Infertile Men

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04937608
Enrollment
2
Registered
2021-06-24
Start date
2021-08-13
Completion date
2021-12-01
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Infertility, Male

Brief summary

This study aims to better understand the effects of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, virus that causes the coronavirus disease 2019 (COVID-19), on male fertility.

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will produce a sperm sample by masturbation. Patients will also complete a questionnaire relating to their state of health. Six month following the first sperm sample, patients will produce another sperm sample by masturbation. These sperm parameters will be compared with the ones from a sperm analysis performed less than 2 years before the SARS-CoV-2 infection.

Interventions

DIAGNOSTIC_TESTSperm analysis

Routine sperm analysis including analysis of sperm concentration, motility, vitality and morphology. Sperm DNA integrity will also be assessed.

Sponsors

Institut national de la recherche scientifique
CollaboratorUNKNOWN
Fertilys
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years

Inclusion criteria

* All men aged 18 to 45 having a sperm analysis done at the Fertilys fertility center in the last 2 years who have not contracted COVID-19, agreeing to participate in the study and having signed the consent form to participate in the study. * All men aged 18 to 45 having a sperm analysis done at the Fertilys fertility center in the last 2 years) who have contracted COVID-19 within the last 6 months, agreeing to participating in the study and having signed the consent form to participate in the study. * All men aged 18 to 45 years with a sperm concentration ≥ 15 million/mL, progressive motility ≥ 20% and a percentage of normal forms ≥ 2%.

Exclusion criteria

* Men aged under 18 and over 45. * Men who cannot produce a sperm sample by antegrade ejaculation. * Men whose sperm concentration is \<15 million/mL, progressive motility \<20% and a percentage of normal forms \<2%, determined following the production of a reference sperm sample, carried out before March 2020, i.e. before the COVID-19 pandemic.

Design outcomes

Primary

MeasureTime frameDescription
Changes in sperm parameters qualityPre-infection, on the day of recruitment and six month laterSperm concentration and motility will be assessed using computer-assisted sperm analysis (CASA). Sperm vitality and morphology will be evaluated using eosine-nigrosine and Romanowsky staining techniques, respectively. DNA fragmentation and sperm chromatin decondensation will be measured using the Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) and aniline blue assays, respectively. These sperm parameters will be compared before and after SARS-CoV-2 infection and between the different time frames.
Viral RNA in seminal plasmaPre-infection, on the day of recruitment and six month laterThe number of SARS-CoV-2 RNA copies and viral particles / mL of seminal plasma will be assessed

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026