COVID-19: A Prevalence Study of Two ART Centres After the Pandemic Lockdown in the USA (COVID-19 Free Clinics)
Completed
Conditions studied: COVID-19
In brief
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.
Key facts
- Study ID
- NCT04466644
- Run by
- Igenomix
- People needed
- 340
- Starts
- 2020-06-08
- Expected to finish
- 2020-08-25
- Last updated by the study team
- 2020-09-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
You may not qualify if…
- Not applicable as there is not exclusion criteria for this study.
Where it is running
- Boston IVF Fertility Clinic — Boston, Massachusetts, United States
- Utah Fertility Clinic — Pleasant Grove, Utah, United States
Full record on ClinicalTrials.gov
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