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OpenTrials
Completed

NCT Number: NCT04496869

Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment

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.

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Key information

Conditions

Infertility Treatment Women

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Femme Mère Enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online Questionnaire

Other

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.

Primary outcomes

  1. Psychological impact assessed by scores of PSS10 scales.

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PsyCovART

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2020
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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