Sperm Preservation in Oncological PatientsFERTICOVIDNCT04487639
Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?
A study testing SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics in people with Sperm Preservation in Oncological Patients and Fertility, run by University Hospital, Clermont-Ferrand at 16 sites in France.
Trial summary
During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Sperm Preservation in Oncological Patients, Fertility, Cryopreservation
- What is being tested?
- SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 16 sitesFrance
- Study dates
- 10 Jul 2020to 31 Dec 2023
- Phase
- Interventional
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Man above 18 years of age, of reproductive age, needing oncofertility preservation through spermatozoa cryopreservation prior to a putative gonadotoxic treatment during the COVID-19 pandemic.
- Symptomatic and asymptomatic COVID-19 patients. A patient is considered as symptomatic if he presents one or several of the following clinical signs: fever, cough, cephalalgia, myalgia, diarrhea, anosmia, pharyngodynia.
- A sufficient number of remaining spermatozoa straws to perform at least six ART attempts
Who cannot join
- Azoospermia
- Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia
- Semen collection failure
- Non-emergency fertility preservation or treatment with low gonadotoxic risk
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction
Bondy, France, 93140
AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS
Clamart, France, 92140
CHU de Clermont-Ferrand - Laboratoire de Virologie
Clermont-Ferrand, France, 63000
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS
Dijon, France
CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS
Grenoble, France, 38000
Hospices Civils de Lyon - Service AMP-CECOS
Lyon, France, 69000
Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS
Marseille, France, 13000
CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS
Nancy, France, 54000
AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS
Paris, France, 75000
AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction
Paris, France, 75014
Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye
Poissy, France, 78300
CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims
Reims, 51000
CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS
Rouen, France, 76000
CHU de Strasbourg - Service de Biologie de la reproduction
Strasbourg, France, 67000
CHU de Toulouse - CECOS Midi-Pyrénées
Toulouse, France, 31000
About this study
Official title: Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?
During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.
Read the detailed description
To perform this, all patient undergoing oncological fertility preservation will be evaluated for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia, pharyngodynia). In addition, a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center. Seminal fluid and spermatozoa will be separated by density gradient centrifugation for a posteriori molecular analysis of SARS-CoV-2 presence.
Will thus be measured, within the same ejaculate, the concordance between the presence of SARS-CoV-2 in the seminal fluid and in the sperm cells fraction.
The investigators will also determine if the virus presence in the sperm is related with :
- (i) the presence of SARS-CoV-2 in the nasal swab;
- (ii) patient symptomatology;
- (iii) a specific serological profile;
- (iv) a particular oncological pathology and / or treatment. The investigators may also find out if the presence of the SARS-CoV-2 in semen affects sperm quality.
This study will be the first one examining the presence of SARS-CoV-2 in semen from cancer patients. This will guarantee the safety of fertility preservation procedures during the COVID-19 pandemic.
- Being tested
- SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics
- Keywords
- Fertility preservation, Sperm, Cancer, COVID-19, SARS-CoV-2
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 research in nasopharyngeal swab, sperm and serologicsDiagnostic test
a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center
| Study group | Role | What they receive |
|---|---|---|
| Cohort : patients needing oncofertility preservation | Experimental | Not described Receives: Diagnostic Test: SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR
Seminal fluid and spermatozoa will be separated by density gradient centrifugation, and SARS-CoV-2 will be detected by RT-qPCR in the both fractions.
Measured: Semen collection day (Day0)
Secondary outcomes (6)
To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate
We will compare SARS-CoV-2 RT-PCR results of seminal fluid and the spermatozoa fractions of the same ejaculate
Measured: Semen collection day (Day0)
To determine if the presence of this virus in sperm is associated with its presence in nasal swabs
we will correlate the SARS-CoV-2 detection (using RT- qPCR) in nasopharyngeal swab, seminal fluid and spermatozoa fractions
Measured: Semen collection day (Day0)
To determine if the presence of this virus in sperm is associated with COVID symptoms
Any patient undergoing oncological fertility preservation will be evaluated for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia, pharyngodynia). We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with COVID symptoms
Measured: Semen collection day (Day0)
To determine if the presence of this virus in sperm is associated with specific serological profiles
Serological tests (Sars-CoV2) will be carried out. We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with specific COVID serological profiles
Measured: Semen collection day (Day0) and 30 to 50 days after (Day 30 to 50)
To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments
We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with patient's oncological pathologies and treatments
Measured: Semen collection day (Day0)
To determine if the presence of this virus in sperm could impair its quality
Before semen density gradient centrifugation and cryopreservation, standards sperm analysis will be performed according to the WHO guideline (2020). We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with standards sperm parameters
Measured: Semen collection day (Day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start10 Jul 2020
- Primary completion2 Jul 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm Preservation in Oncological PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine
- Responsible party
- Sponsor
- Investigators
- Florence BRUGNON, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487639
- Sponsor's protocol ID
- RNI 2020 BRUGNON
- Other IDs
- 2020-A01409-30
- Acronym
- FERTICOVID
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2020
- Last updated
- 3 Aug 2026
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?
- ClinicalTrials.gov ID
- NCT04487639
- Acronym / sponsor ID
- FERTICOVID / RNI 2020 BRUGNON
- Keywords
- Fertility preservation, Sperm, Cancer, COVID-19, SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Jul 2020 (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.
During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.
Detailed description
To perform this, all patient undergoing oncological fertility preservation will be evaluated for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia, pharyngodynia). In addition, a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center. Seminal fluid and spermatozoa will be separated by density gradient centrifugation for a posteriori molecular analysis of SARS-CoV-2 presence.
Will thus be measured, within the same ejaculate, the concordance between the presence of SARS-CoV-2 in the seminal fluid and in the sperm cells fraction.
The investigators will also determine if the virus presence in the sperm is related with :
- (i) the presence of SARS-CoV-2 in the nasal swab;
- (ii) patient symptomatology;
- (iii) a specific serological profile;
- (iv) a particular oncological pathology and / or treatment. The investigators may also find out if the presence of the SARS-CoV-2 in semen affects sperm quality.
This study will be the first one examining the presence of SARS-CoV-2 in semen from cancer patients. This will guarantee the safety of fertility preservation procedures during the COVID-19 pandemic.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort : patients needing oncofertility preservation | Experimental | Diagnostic Test: SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Man above 18 years of age, of reproductive age, needing oncofertility preservation through spermatozoa cryopreservation prior to a putative gonadotoxic treatment during the COVID-19 pandemic.
- Symptomatic and asymptomatic COVID-19 patients. A patient is considered as symptomatic if he presents one or several of the following clinical signs: fever, cough, cephalalgia, myalgia, diarrhea, anosmia, pharyngodynia.
- A sufficient number of remaining spermatozoa straws to perform at least six ART attempts
Key exclusion criteria (4 listed)
- Azoospermia
- Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia
- Semen collection failure
- Non-emergency fertility preservation or treatment with low gonadotoxic risk
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 |
|---|---|---|
| SARS-CoV-2 research in nasopharyngeal swab, sperm and serologicsa nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center | Diagnostic test | Cohort : patients needing oncofertility preservation |
Primary outcome
Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR
Time frame: Semen collection day (Day0)
Seminal fluid and spermatozoa will be separated by density gradient centrifugation, and SARS-CoV-2 will be detected by RT-qPCR in the both fractions.
6 secondary outcomes
To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate
Time frame: Semen collection day (Day0)
To determine if the presence of this virus in sperm is associated with its presence in nasal swabs
Time frame: Semen collection day (Day0)
To determine if the presence of this virus in sperm is associated with COVID symptoms
Time frame: Semen collection day (Day0)
To determine if the presence of this virus in sperm is associated with specific serological profiles
Time frame: Semen collection day (Day0) and 30 to 50 days after (Day 30 to 50)
To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments
Time frame: Semen collection day (Day0)
To determine if the presence of this virus in sperm could impair its quality
Time frame: Semen collection day (Day0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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.
Florence BRUGNON, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics in people with Sperm Preservation in Oncological Patients and Fertility, run by University Hospital, Clermont-Ferrand at 16 sites in France.
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 4 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: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR (time frame: Semen collection day (Day0)). 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 3 Aug 2026.