Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment
PsyCovART
1 other identifier
observational
435
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
June 15, 2020
CompletedStudy Start
First participant enrolled
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedJuly 13, 2021
May 1, 2021
2 months
June 15, 2020
July 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Interventions
the investigators sent by email a Googleform online questionnaires to women followed in ART center of HFME (Hospital Femme-Mère-Enfant) . Questions are about demographic characteristics, ART history, feeling during the lockdown. To evaluate psychological impact, the investigators use PSS10 and HADS scales. Both scales are worldwide validated and used in recent COVID19's research. the investigators add some quantitative questions about de feeling during the look down, ART interruption, pregnancy desire.
Eligibility Criteria
Women between 18 and 42 years and 12 months, followed in the infertility Center of Femme Mère Enfant Hospital (HFME - Bron - France).
You may qualify if:
- Consulting the center between 01/01/2020 to 12/31/2020
- Email address in the medical records
- All causes of infertility
You may not qualify if:
- Women followed for:
- Preservation of fertility
- Oocyte donation
- Women who do not speak or read French
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Femme Mère Enfant
Bron, 69500, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2020
First Posted
August 3, 2020
Study Start
July 7, 2020
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
July 13, 2021
Record last verified: 2021-05