Covid19NCT04937608
Impact of the Coronavirus Disease 2019 (COVID-19) on Sperm Parameters
An observational study of Covid19 and Infertility, Male, run by Fertilys at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Covid19, Infertility, Male
- What is being tested?
- Sperm analysis
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 13 Aug 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Adult
Study population: See Eligibility Criteria
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection on the Sperm Parameters of Infertile Men
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.
Read the 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.
- Conditions
- Covid19, Infertility, Male
- Being tested
- Sperm analysis
- Medical subject headings
- COVID-19, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm analysisDiagnostic test
Routine sperm analysis including analysis of sperm concentration, motility, vitality and morphology. Sperm DNA integrity will also be assessed.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 group | men aged 18 to 45 who have been infected with SARS-CoV-2 in the past 6 months Receives: 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 Receives: Diagnostic Test: Sperm analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Pre-infection, on the day of recruitment and six month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start13 Aug 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Why it stopped: Lack of staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertilys
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut national de la recherche scientifique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937608
- Sponsor's protocol ID
- COVID-19 and sperm parameters
- Status last verified
- Sep 2023
- First submitted
- 21 Jun 2021
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection on the Sperm Parameters of Infertile Men
- ClinicalTrials.gov ID
- NCT04937608
- Acronym / sponsor ID
- COVID-19 and sperm parameters
- Conditions
- Covid19, Infertility, Male
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of staff
- Enrolment
- 2 participants (actual)
- Lead sponsor
- FertilysIndustry (pharma, biotech, devices)
- Collaborators
- Institut national de la recherche scientifique
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 group | – | Diagnostic Test: Sperm analysismen aged 18 to 45 who have been infected with SARS-CoV-2 in the past 6 months |
| Control group | – | Diagnostic Test: Sperm analysishealthy men aged 18 to 45 with normal sperm parameters (WHO 2010 criteria) and who have never contracted COVID-19 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- See Eligibility Criteria
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sperm analysisRoutine sperm analysis including analysis of sperm concentration, motility, vitality and morphology. Sperm DNA integrity will also be assessed. | Diagnostic test | COVID-19 group, Control group |
Primary outcome
Changes in sperm parameters quality
Time frame: 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.
Viral RNA in seminal plasma
Time frame: 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
Results and safety
The study was stopped early (reason given: Lack of staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Infertility, Male, run by Fertilys at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sperm parameters quality (time frame: Pre-infection, on the day of recruitment and six month later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.