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NCT04466644 · ClinicalTrials.gov registry record
COVID-19: A Prevalence Study of Two ART Centres After the Pandemic Lockdown in the USA (COVID-19 Free Clinics)
A clinical trial, sponsored by Igenomix.
- Completed
- Registry status
- 340
- Enrollment target
NCT04466644: Completed study, sponsored by Igenomix.
NCT04466644 is a clinical trial that has completed, run by Igenomix. The registered enrollment target is 340 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04466644 has completed, sponsored by Igenomix.
- COMPLETED
- Registry status
- 340 participants
- Enrollment target
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.
Primary Outcome
Statistical quantification of the prevalence of contagiousness in asymptomatic individuals attending IVF clinics in the USA based on the gold standard test (PCR).
Interventions
- DIAGNOSTIC_TEST RT-PCR
- DIAGNOSTIC_TEST ELISA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2020-08-25 |
What the finished NCT04466644 record still lists
NCT04466644 is an observational study that tracks outcomes without assigning an intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which RT-PCR is the first listed.
NCT04466644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04466644 about?
NCT04466644 is a clinical study titled "COVID-19: A Prevalence Study of Two ART Centres After the Pandemic Lockdown in the USA (COVID-19 Free Clinics)". 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 ...
What is the current status of trial NCT04466644?
This trial is currently completed. The enrollment target is 340 participants. The study started on 2020-06-08. Estimated completion is 2020-08-25.
What interventions are being tested in trial NCT04466644?
The interventions under investigation include: RT-PCR (DIAGNOSTIC_TEST), ELISA (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04466644?
This trial is sponsored by Igenomix, which has 4 total clinical trials registered on ClinicalTrials.gov.
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