NCT04420169

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Longer than P75 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

May 1, 2016

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

5.6 years

First QC Date

June 3, 2020

Last Update Submit

February 13, 2023

Conditions

CommunicationIVF

Outcome Measures

Primary Outcomes (1)

  • How do patients evaluate the communication by the midwife in anticipation of the IVF treatment cycle?

    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

Study Arms (2)

PRE implementation communication protocol

Other: Questionnaire

POST implementation communication protocol

Other: Questionnaire

Interventions

QuestionnaireOTHER

A digital questionnaire to evaluate the communication by midwives will be send out to IVF patients

POST implementation communication protocolPRE implementation communication protocol

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Communication

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 9, 2020

Study Start

May 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)