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NCT Number: NCT04487639

Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?

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.

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Key information

Conditions

Sperm Preservation in Oncological Patients COVID-19 Coronaviridae Infections Coronavirus Infections Cryopreservation Fertility Infections Lung Diseases Neoplasms Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction, Bondy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Azoospermia
  • Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia
  • Semen collection failure
  • Non-emergency fertility preservation or treatment with low gonadotoxic risk

Treatment and study plan

SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics

Diagnostic 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    We will compare SARS-CoV-2 RT-PCR results of seminal fluid and the spermatozoa fractions of the same ejaculate

  2. To determine if the presence of this virus in sperm is associated with its presence in nasal swabs

    Time frame: Semen collection day (Day0)

    we will correlate the SARS-CoV-2 detection (using RT- qPCR) in nasopharyngeal swab, seminal fluid and spermatozoa fractions

  3. To determine if the presence of this virus in sperm is associated with COVID symptoms

    Time frame: Semen collection day (Day0)

    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

  4. 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)

    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

  5. To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments

    Time frame: Semen collection day (Day0)

    We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with patient's oncological pathologies and treatments

  6. To determine if the presence of this virus in sperm could impair its quality

    Time frame: Semen collection day (Day0)

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Agence de La Biomédecine

Registry information

Official study title

Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?

Acronym: FERTICOVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Jul 27, 2020
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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