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COVID-19: A Prevalence Study of Two ART Centres After the Pandemic Lockdown in the USA (COVID-19 Free Clinics)

NCT04466644 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 340

Last updated 2020-09-14

No results posted yet for this study

Summary

In late December 2019, a new coronavirus strain emerged 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. Several emergency measures have been implemented in different countries such as lockdown, social distancing, and testing.

The pandemic concerns to public worldwide but also to couples aiming to conceive through natural means or undergoing assisted reproductive technologies (ART). The American Society of Reproductive Medicine (ASRM) as well as European Society of Human Reproduction and Embryology (ESHRE) have recommend a precautionary approach and advise that all fertility patients considering or planning treatment, even if they do not meet the diagnostic criteria for COVID-19 infection, should avoid becoming pregnant at this time until more is known about the virus. Therefore, new cycles for infertility patients as well as non-medically urgent gamete preservation treatments, such as social egg freezing, have been suspended deferring embryo transfer in those patients with initiated cycles. In this moment, when reopening phases are being undertaken in most countries, the decision to resume the In vitro fertilization (IVF) treatment in a safe environment to the healthcare workers and patients is the biggest concern of the ART clinics.

The present study aims to describe the percentage of COVID-19 condition (naïve, immune, and currently infected) in asymptomatic individuals from two different ART centres. For this purpose, the ART centres' personnel and patients will be tested for COVID-19 before resume the clinic daily routine just after the lockdown period.

Conditions

Interventions

DIAGNOSTIC_TEST

ELISA

Antibody test (serology) in the blood samples to determine if the subject was previously infected.

DIAGNOSTIC_TEST

RT-PCR

For detecting the presence of SARS-CoV-2 RNA molecule in the nasopharyngeal swabs and saliva.

Sponsors & Collaborators

  • Igenomix

    lead INDUSTRY

Principal Investigators

  • Juliana Cuzzi, PhD · Igenomix

  • Carlos Simon, MD, PhD · Igenomix

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-08
Primary Completion
2020-08-24
Completion
2020-08-25

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04466644 on ClinicalTrials.gov