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

Terminated

• Conditions: Covid19; Infertility, Male

• Registration Number: NCT04937608
• Lead Sponsor: Fertilys

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.

Study Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-24
• Study Start: 2021-08-13
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral RNA in seminal plasma	Pre-infection, on the day of recruitment and six month later	The number of SARS-CoV-2 RNA copies and viral particles / mL of seminal plasma will be assessed
Changes in sperm parameters quality	Pre-infection, on the day of recruitment and six month later	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.

Trial Locations

Locations (1)

Fertilys; 🇨🇦 Laval, Quebec, Canada