SARS-CoV-2COVID-19CASTNCT04717011
Case Series Study to Detect SARS-CoV-2 in Semen of COVID-19 Patients
An observational study of SARS-CoV-2, run by Igenomix at 1 site in Spain.
Trial summary
A descriptive, clinical series, single-centre, national, biomedical study to determine the presence of SARS-CoV-2 in sperm samples from positive PCR patients for COVID-19 and to evaluate the presence of the virus in the sperm samples after a negative PCR for COVID-19 Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- PCR test
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2021to Jul 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include males diagnosed with COVID-19 by positive PCR with ages between 18-65. These patients will be recruited from all participant departments of the hospital and organized by the Quality and/or Occupational Safety department.
Who may be able to join
- Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
- Male age: 18 - 65 years, both included.
- COVID-19 positive result by PCR (including symptomatic and asymptomatic subjects).
Who cannot join
- Patients with severe symptoms or any other medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and his compliance in the study
- Known medical history of azoospermia or anejaculation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Ruber Internacional
Madrid, 28034
Jesus Maria R Franco, +34913875000, jesusm.franco@ruberinternacional.es
About this study
Official title: Case Series Biomedical Study to Detect the Presence of SARS-CoV-2 in Semen of Patients Diagnosed With COVID-19 Disease
A descriptive, clinical series, single-centre, national, biomedical study to determine the presence of SARS-CoV-2 in sperm samples from positive PCR patients for COVID-19 and to evaluate the presence of the virus in the sperm samples after a negative PCR for COVID-19
Read the detailed description
In late December 2019, a new coronavirus strain emerged in China causing coronavirus disease 2019 (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a "public health emergency of international concern" by the International Health Regulations Emergency Committee of the WHO on January 30, 2020. The pandemic concerns to public worldwide but also to couples aiming to conceive through natural means or undergoing assisted reproductive technologies (ART). Different organizations including the American Society of Reproductive Medicine have recommended a precautionary approach. Therefore, new cycles for infertility patients as well as non-medically urgent gamete preservation treatments, such as social egg freezing, have been suspended in many countries. The decision to resume the In vitro fertilization (IVF) treatment make us to question if virus could be in gametes affecting couples and reproductive outcomes. The presence of the virus in sperm have contradictory results.
The present study aims to describe if there could be presence of virus in sperm samples of patients with positive diagnosis for COVID-19, and if so, if the virus turns negative on the sperm after the patient recovers and have a negative result for COVID-19. Also it aims to assess the presence of the virus in the seminal plasma and discern if it possible to disseminate it by sexual transmission.
An interim analysis is expected to be carried out once the 50% of the expected recruitment is achieved.
- Conditions
- SARS-CoV-2
- Being tested
- PCR test
- Keywords
- SARS-CoV-2, COVID-19, Severe acute respiratory syndrome coronavirus 2, Semen
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR testDiagnostic test
PCR test in two different semen samples from each patient: first with positive diagnosis for COVID-19 and the second after negative diagnosis for COVID-19.
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 semen result
PCR results in semen specimen samples with patient COVID-19 positive test
Measured: 1 day
Secondary outcomes (1)
SARS-CoV-2 semen result
PCR results in semen specimen samples with patient COVID-19 negative test
Measured: 2-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Simon, MD, PhD, Study chair, IgenomixNasser Al-Asmar, PhD, Principal investigator, Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717011
- Sponsor's protocol ID
- IGX1-COV-NA-20-05
- Acronym
- COVID-19CAST
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Series Biomedical Study to Detect the Presence of SARS-CoV-2 in Semen of Patients Diagnosed With COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04717011
- Acronym / sponsor ID
- COVID-19CAST / IGX1-COV-NA-20-05
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, COVID-19, Severe acute respiratory syndrome coronavirus 2, Semen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 20 Jan 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.
A descriptive, clinical series, single-centre, national, biomedical study to determine the presence of SARS-CoV-2 in sperm samples from positive PCR patients for COVID-19 and to evaluate the presence of the virus in the sperm samples after a negative PCR for COVID-19
Detailed description
In late December 2019, a new coronavirus strain emerged in China causing coronavirus disease 2019 (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a "public health emergency of international concern" by the International Health Regulations Emergency Committee of the WHO on January 30, 2020. The pandemic concerns to public worldwide but also to couples aiming to conceive through natural means or undergoing assisted reproductive technologies (ART). Different organizations including the American Society of Reproductive Medicine have recommended a precautionary approach. Therefore, new cycles for infertility patients as well as non-medically urgent gamete preservation treatments, such as social egg freezing, have been suspended in many countries. The decision to resume the In vitro fertilization (IVF) treatment make us to question if virus could be in gametes affecting couples and reproductive outcomes. The presence of the virus in sperm have contradictory results.
The present study aims to describe if there could be presence of virus in sperm samples of patients with positive diagnosis for COVID-19, and if so, if the virus turns negative on the sperm after the patient recovers and have a negative result for COVID-19. Also it aims to assess the presence of the virus in the seminal plasma and discern if it possible to disseminate it by sexual transmission.
An interim analysis is expected to be carried out once the 50% of the expected recruitment is achieved.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include males diagnosed with COVID-19 by positive PCR with ages between 18-65. These patients will be recruited from all participant departments of the hospital and organized by the Quality and/or Occupational Safety department.
Key inclusion criteria (3 listed)
- Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
- Male age: 18 - 65 years, both included.
- COVID-19 positive result by PCR (including symptomatic and asymptomatic subjects).
Key exclusion criteria (2 listed)
- Patients with severe symptoms or any other medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and his compliance in the study
- Known medical history of azoospermia or anejaculation
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 |
|---|---|---|
| PCR testPCR test in two different semen samples from each patient: first with positive diagnosis for COVID-19 and the second after negative diagnosis for COVID-19. | Diagnostic test | – |
Primary outcome
SARS-CoV-2 semen result
Time frame: 1 day
PCR results in semen specimen samples with patient COVID-19 positive test
1 secondary outcome
SARS-CoV-2 semen result
Time frame: 2-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- 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.
Carlos Simon, MD, PhD study chair
Igenomix
Nasser Al-Asmar, PhD principal investigator
Igenomix
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 SARS-CoV-2, run by Igenomix at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Gomez, BSc, MSc (+34963905310, carlos.gomez@igenomix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 semen result (time frame: 1 day). 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 10 Feb 2021; AzTrials last refreshed its copy on 3 Nov 2026.