COVID-19: A Prevalence Study of Two ART Centres After the Pandemic Lockdown in the USA (COVID-19 Free Clinics)
A Multicenter, Prevalence Study to Evaluate the Infectious and Immunological Status of COVID-19 in Asymptomatic Subjects Attending ART Centres After the Pandemic Lockdown in the USA
2 other identifiers
observational
340
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 8, 2020
CompletedFirst Submitted
Initial submission to the registry
July 9, 2020
CompletedFirst Posted
Study publicly available on registry
July 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2020
CompletedSeptember 14, 2020
September 1, 2020
3 months
July 9, 2020
September 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevalence of contagiousness in asymptomatic individuals by PCR with nasopharyngeal swabs
Statistical quantification of the prevalence of contagiousness in asymptomatic individuals attending IVF clinics in the USA based on the gold standard test (PCR).
2 months
Ratio of asymptomatic immunized (IgG) population
Statistical quantification of the rate of immunized (IgG) individuals attending to IVF clinics in the USA based on the ELISA test.
2 months
Secondary Outcomes (1)
To validate saliva specimens as a biological sample for COVID-19 testing
2 months
Other Outcomes (1)
Description of demographic characteristics
2 months
Study Arms (1)
The regulars of IVF clinics in the USA
Mainly asymptomatic individuals composed by patients who are attending their regular medical consultation and/ clinic staff of the participant sites, located in two areas of the USA with different pandemic status, and undergoing PCR and ELISA tests for diagnosis of COVID-19 before initiating the work after the lockdown.
Interventions
Antibody test (serology) in the blood samples to determine if the subject was previously infected.
For detecting the presence of SARS-CoV-2 RNA molecule in the nasopharyngeal swabs and saliva.
Eligibility Criteria
Mainly asymptomatic subjects composed by patients who are attending for their regular medical consultation and clinic staff for COVID-19 infection from the two participant sites, located in two areas with different pandemic status, before initiating the work immediately after the lockdown period.
You may qualify if:
- Age of majority subjects whose written informed consent approved by the IRB 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.
- Site staff who are re-incorporating to the centers and patients who are attending their medical appointment for their regular IVF treatment.
- Mainly asymptomatic individuals from the ART clinics, before initiating the work right after the lockdown period.
- Note: COVID-19 symptomatology may appear 2-14 days after exposure to the virus and may include at least one of the following symptoms:
- Fever
- Cough
- Shortness of breath or difficulty breathing
- Chills
- Repeated shaking with chills
- Muscle pain
- Headache
- Sore throat
- New loss of taste or smell
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Igenomixlead
Study Sites (2)
Boston IVF Fertility Clinic
Boston, Massachusetts, 02109, United States
Utah Fertility Clinic
Pleasant Grove, Utah, 84062, United States
Biospecimen
* Blood * Saliva * Nasopharyngeal swab
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliana Cuzzi, PhD
Igenomix
- PRINCIPAL INVESTIGATOR
Carlos Simon, MD, PhD
Igenomix
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 10, 2020
Study Start
June 8, 2020
Primary Completion
August 24, 2020
Study Completion
August 25, 2020
Last Updated
September 14, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share