Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?
NCT ID: NCT04487639
Last Updated: 2024-02-16
Study Results
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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COMPLETED
NA
129 participants
INTERVENTIONAL
2020-07-10
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Cohort : patients needing oncofertility preservation
SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics
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
Interventions
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SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia
* Semen collection failure
* Non-emergency fertility preservation or treatment with low gonadotoxic risk
18 Years
60 Years
MALE
No
Sponsors
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Agence de La Biomédecine
OTHER_GOV
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Florence BRUGNON, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Clermont-Ferrand
Locations
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AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction
Bondy, , France
AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS
Clamart, , France
CHU de Clermont-Ferrand - Laboratoire de Virologie
Clermont-Ferrand, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS
Dijon, , France
CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS
Grenoble, , France
Hospices Civils de Lyon - Service AMP-CECOS
Lyon, , France
Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS
Marseille, , France
CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS
Nancy, , France
AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS
Paris, , France
AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction
Paris, , France
Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye
Poissy, , France
CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims
Reims, , France
CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS
Rouen, , France
CHU de Strasbourg - Service de Biologie de la reproduction
Strasbourg, , France
CHU de Toulouse - CECOS Midi-Pyrénées
Toulouse, , France
Countries
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Other Identifiers
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2020-A01409-30
Identifier Type: OTHER
Identifier Source: secondary_id
RNI 2020 BRUGNON
Identifier Type: -
Identifier Source: org_study_id
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