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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04937608
• Other study ID #: COVID-19 and sperm parameters
• Status: Terminated
• Start date: August 13, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2023
• Source: Fertilys
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Infertility
• Infertility, Male

Intervention

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

Locations

Country	Name	City	State
Canada	Fertilys	Laval	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Fertilys	Institut national de la recherche scientifique

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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