NCT04456010

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 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

Study Start

First participant enrolled

June 1, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

June 15, 2020

Last Update Submit

December 28, 2020

Conditions

Keywords

fertilityrisk perceptionemotional experience

Outcome Measures

Primary Outcomes (1)

  • Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment pandemic and the discontinuation

    Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment, via a survey

    1 day

Secondary Outcomes (2)

  • Risk assessment

    1 day

  • Patients'expectations regarding the management of an abrupt closure of the fertility center

    1 day

Study Arms (1)

Infertile couple

Infertile couple who had a fertility treatment prescribed during the past 9 months which was not completed yet.

Other: Questionnaire

Interventions

Eligible patients will be selected from our electronical database and invited via email to participate.

Infertile couple

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

COVID-19Infertility

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Noémie Ranisavljevic, M.D., Ph.D

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 15, 2020

First Posted

July 2, 2020

Study Start

June 1, 2020

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations