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

NCT ID: NCT04937608

Last Updated: 2023-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-13

Study Completion Date

2021-12-01

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.

Conditions

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Covid19 Infertility, Male

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 group

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

Sperm analysis

Intervention Type DIAGNOSTIC_TEST

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

Control group

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

Sperm analysis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Sperm analysis

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

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Institut national de la recherche scientifique

UNKNOWN

Sponsor Role collaborator

Fertilys

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fertilys

Laval, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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COVID-19 and sperm parameters

Identifier Type: -

Identifier Source: org_study_id

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