Uniform Communication by Midwives in Preparation for an IVF Treatment (UNCOVeR)

February 13, 2023 updated by: University Hospital, Ghent
Dutch-speaking women who are about to start an IVF treatment will be approached. If they are willing to participate in the study, they will receive an email with a link to an online questionnaire. This questionnaire will evaluate the communication by the midwive in preparation for an IVF treatment. When 50 women have completed the questionnaire a standardized communication protocol will be enrolled. Once all midwives are trained, 50 other IVF patients will be asked to complete the slightly adapted post questionnaire.The data from both questionnaires will be compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105

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

      • Gent, Belgium, 9000
        • Ghent University Hospital

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

Female

Sampling Method

Probability Sample

Study Population

Dutch-speaking women who are about to start an IVF treatment at our department.

Description

Inclusion Criteria:

  • women who are about to start an IVF treatment at our department

Exclusion Criteria:

  • non-Dutch speaking
  • women who are counseled by one of the midwives involved in the design of this study

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
PRE implementation communication protocol
A digital questionnaire to evaluate the communication by midwives will be send out to IVF patients
POST implementation communication protocol
A digital questionnaire to evaluate the communication by midwives will be send out to IVF patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
How do patients evaluate the communication by the midwife in anticipation of the IVF treatment cycle?
Time Frame: About 20 weeks counting from the launch of each questionnaire or earlier if the target of 50 patients is reached sooner
Self created questionnaire (no scale)
About 20 weeks counting from the launch of each questionnaire or earlier if the target of 50 patients is reached sooner

Collaborators and Investigators

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

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)

May 1, 2016

Primary Completion (ACTUAL)

December 1, 2021

Study Completion (ACTUAL)

December 1, 2021

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (ACTUAL)

June 9, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • B670201627388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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