NCT04496869

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
435

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

July 7, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

July 13, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

June 15, 2020

Last Update Submit

July 12, 2021

Conditions

Keywords

psychological responseinfertility treatmentlockdown period

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

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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).

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

Location

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

Locations