Women Clinical Trial
— PsyCovARTOfficial title:
Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment, a French Cohort
NCT number | NCT04496869 |
Other study ID # | 69HCL20_0577 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 7, 2020 |
Est. completion date | August 31, 2020 |
Verified date | May 2021 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 435 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 43 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Femme Mère Enfant | Bron |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psychological impact assessed by scores of PSS10 scales. | 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 | |
Primary | Psychological impact assessed by scores of HADS scales. | 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 |
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