COVID-19 in ART: Perception and Experience (COVAPEX)

December 28, 2020 updated by: University Hospital, Montpellier

Assessing the Perception and the Personal Experience of the COVID19 Pandemic Among Infertile Couples Undergoing Assisted Reproductive Treatment (ART)

Non-urgent medical care, such as fertility treatments, has been massively postponed during the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might cause anxiety and depression among infertile couples, who are already exposed to the distressing experience of infertility and for whom the wait for a baby already appears unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and foetus, or on fertility.

This study aims to assess the views of infertile couple regarding the potential risks of COVID during their fertility treatment and their personal experience of the COVID pandemic and their expectation for further treatment .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

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

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infertile couple (male and female) who had a fertility treatment prescribed during the past 9 months (prescription after October 1st, 2019) in the fertility department of Montpellier Hospital

Description

Inclusion criteria:

- Men and women who had a fertility treatment prescribed during the past 9 months in our Fertility department

Exclusion criteria:

  • Patient attending for a fertility preservation
  • Patient attending for a preimplantation genetic testing (PGT-M or PGT-SR)
  • Patient not fluent in French

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infertile couple
Infertile couple who had a fertility treatment prescribed during the past 9 months which was not completed yet.
Other: Questionnaire
Eligible patients will be selected from our electronical database and invited via email to participate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment pandemic and the discontinuation
Time Frame: 1 day
Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment, via a survey
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk assessment
Time Frame: 1 day
. Risk assessment by the patient, via a survey, regarding SARS-CoV-2 during a fertility treatment or during pregnancy. Perception of the risks linked to SARS-CoV-2 during their fertility treatment or during a pregnancy
1 day
Patients'expectations regarding the management of an abrupt closure of the fertility center
Time Frame: 1 day
Patients'expectations regarding the management of an abrupt closure of the fertility center, via a survey
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

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)

June 1, 2020

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

July 30, 2020

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

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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