PsyCovART: Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT04496869
• Collaborator: (none)
• Enrollment: 435
• Location: 1
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 240.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility Treatment; Women	Other: Online questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 435 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment, a French Cohort
• Actual Study Start Date: Jul 7, 2020
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Outcome Measures

Primary Outcome Measures

1. Psychological impact assessed by scores of PSS10 scales. [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.

2. Psychological impact assessed by scores of HADS scales. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 43 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Femme Mère Enfant	Bron		France	69500

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04496869
• Other Study ID Numbers: 69HCL20_0577
• First Posted: Aug 3, 2020
• Last Update Posted: Jul 13, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: psychological response; infertility treatment; lockdown period
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Jul 13, 2021