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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Infertility, Male

Intervention / Treatment
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* Diagnostic Test: Sperm analysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 group<br>men aged 18 to 45 who have been infected with SARS-CoV-2 in the past 6 months | Diagnostic Test: Sperm analysis<br>* Routine sperm analysis including analysis of sperm concentration, motility, vitality and morphology. Sperm DNA integrity will also be assessed.<br>|
| Control group<br>healthy men aged 18 to 45 with normal sperm parameters (WHO 2010 criteria) and who have never contracted COVID-19 | Diagnostic Test: Sperm analysis<br>* Routine sperm analysis including analysis of sperm concentration, motility, vitality and morphology. Sperm DNA integrity will also be assessed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |