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: Completed
• Conditions: Women; Infertility Treatment
• Intervention / Treatment: Other: Online questionnaire

• Study Type: Observational
• Enrollment (Actual): 435

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hopital Femme Mere Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between 18 and 42 years and 12 months, followed in the infertility Center of Femme Mère Enfant Hospital (HFME - Bron - France).

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: infertility treatment; psychological response; lockdown period
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 69HCL20_0577

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No