Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment

Women Clinical Trial

— PsyCovART  

Official title:

Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment, a French Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496869
• Other study ID #: 69HCL20_0577
• Status: Completed
• Start date: July 7, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: May 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Infertility
• Infertility Treatment
• Women

Intervention

Other:
• Online questionnaire
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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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