- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556630
Experience of Lock Down Related to the Covid-19 Epidemic and Its Impact on the Project of Parenthood (CONFIN-AMP)
February 28, 2022 updated by: University Hospital, Lille
Evaluation of the Experience of Lock Down Related to the Covid-19 Epidemic and Its Impact on the Project of Parenthood of the Couples Followed in Assisted Reproduction
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Lille, France, 59037
- Hop Calmette Chu Lille
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
couples followed up in Assisted Reproduction and CECOS Nord
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Level of anxiety and/or depression of MPA patients (male and female couples) by Hospital Anxiety and Depression Scale (HAD) score.
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bérengère DUCROCQ, MD, University Hospital, Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2020
Primary Completion (Actual)
June 22, 2021
Study Completion (Actual)
June 22, 2021
Study Registration Dates
First Submitted
September 18, 2020
First Submitted That Met QC Criteria
September 18, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
March 2, 2022
Last Update Submitted That Met QC Criteria
February 28, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2020_65
- 2020-A01810-39 (Other Identifier: ID-RCB number,ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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