Experience of Lock Down Related to the Covid-19 Epidemic... | NCT04556630

Studies
Experience of Lock Down Related to the Covid-19 Epidemic and Its Impact on the Project of Parenthood

NCT04556630

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Mar 2, 2022Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Assisted Reproduction

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A01810-39	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2020Actual

Primary Completion Date

Jun 22, 2021Actual

Completion Date

Jun 22, 2021Actual

First Submitted Date

Sep 18, 2020

First Submission Date that Met QC Criteria

Sep 18, 2020

First Posted Date

Sep 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2022

Last Update Posted Date

Mar 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Observational, descriptive, cross-sectional, monocentric study, This Study is proposed to all couples followed in Assisted Reproduction and CECOS Nord for whom the protocols were stopped when they entered into confinement related to the Covid-19 epidemic on 13 March 2020.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of anxiety and/or depression of MPA patients (male and female couples) by Hospital Anxiety and Depression Scale (HAD) score.		Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

couples followed up in Assisted Reproduction and CECOS Nord
the cessation of assistance reproduction protocols related to the Covid-19 outbreak on March 13, 2020.
acceptance of teleconsultation

Exclusion Criteria:

Individuals refusing to participate in the study during the teleconsultation with the referring practitioner.

I- ndividuals who do not respond to the questionnaire

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

couples followed up in Assisted Reproduction and CECOS Nord

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bérengère DUCROCQ, MD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hop Calmette Chu Lille		Lille		59037	France