- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04496869
Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment (PsyCovART)
Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment, a French Cohort
In France, one couple in eight encounters difficulties to conceive. The diagnosis of infertility frequently leads to symptoms of anxiety and depression. These symptoms appear to be higher than in the general population.
Some recent studies have looked at the relationship between anxiety and depression in ART cares.
Results are controversial, but it appears that patients with lower levels of anxiety and depression have higher pregnancy rates. Moreover, in couple, women seem to have more symptoms of anxiety and depression than men.
First epidemiological studies related to the COVID 19 pandemic have shown strong psychological impact on the general population with an anxiety rate estimated at more than 30%.
With COVID 19 pandemic and cessation of ART, it is highly likely that psychic symptoms of anxiety or even depression may have appeared or worsened in women undergoing infertility treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bron, France, 69500
- Hôpital Femme Mère Enfant
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Consulting the center between 01/01/2020 to 12/31/2020
- Email address in the medical records
- All causes of infertility
Exclusion Criteria:
- Women followed for:
- Preservation of fertility
- Oocyte donation
- Women who do not speak or read French
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological impact assessed by scores of PSS10 scales.
Time Frame: baseline
|
Perceived Stress Scale 10 assess stress in 10 questions with score from 0 to 40.
The higher the score is, the more important the stress level is.
|
baseline
|
Psychological impact assessed by scores of HADS scales.
Time Frame: baseline
|
depression Scale with 14 questions.
It assesses separately anxiety (score from 0 to 21) and depression (score from 0 to 21).The higher the score is, the more important the anxiety level is.
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL20_0577
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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