NCT04556630

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 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

September 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

September 18, 2020

Last Update Submit

February 28, 2022

Conditions

Assisted Reproduction

Outcome Measures

Primary Outcomes (1)

  • Level of anxiety and/or depression of MPA patients (male and female couples) by Hospital Anxiety and Depression Scale (HAD) score.

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

couples followed up in Assisted Reproduction and CECOS Nord

You may qualify if:

  • 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

You may not qualify if:

  • Individuals refusing to participate in the study during the teleconsultation with the referring practitioner.
  • I- ndividuals who do not respond to the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Calmette Chu Lille

Lille, 59037, France

Location

Study Officials

  • Bérengère DUCROCQ, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 21, 2020

Study Start

December 9, 2020

Primary Completion

June 22, 2021

Study Completion

June 22, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

FR(1)