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

NCT04937608 | Terminated DMC

• 1 other identifier: COVID-19 and sperm parameters
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Infertility, Male

Outcome Measures

Primary Outcomes (2)

• Changes in sperm parameters quality

  Sperm 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.

  Pre-infection, on the day of recruitment and six month later

• Viral RNA in seminal plasma

  The number of SARS-CoV-2 RNA copies and viral particles / mL of seminal plasma will be assessed

  Pre-infection, on the day of recruitment and six month later

Study Arms (2)

COVID-19 group

men aged 18 to 45 who have been infected with SARS-CoV-2 in the past 6 months

Diagnostic Test: Sperm analysis

Control group

healthy men aged 18 to 45 with normal sperm parameters (WHO 2010 criteria) and who have never contracted COVID-19

Diagnostic Test: Sperm analysis

Interventions

Sperm analysis DIAGNOSTIC_TEST

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

COVID-19 group; Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

See Eligibility Criteria

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fertilys: lead
• Institut national de la recherche scientifique: collaborator

Study Sites (1)

Fertilys

Laval, Quebec, H2P2L6, Canada

Location

MeSH Terms

Conditions

COVID-19; Infertility, Male

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 24, 2021
• Study Start: August 13, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)