<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04420169</url>
  </required_header>
  <id_info>
    <org_study_id>B670201627388</org_study_id>
    <nct_id>NCT04420169</nct_id>
  </id_info>
  <brief_title>Uniform Communication by Midwives in Preparation for an IVF Treatment</brief_title>
  <acronym>UNCOVeR</acronym>
  <official_title>Uniform Communication by Midwives in Preparation for an IVF Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dutch-speaking women who are about to start an IVF treatment will be approached. If they are&#xD;
      willing to participate in the study, they will receive an email with a link to an online&#xD;
      questionnaire. This questionnaire will evaluate the communication by the midwive in&#xD;
      preparation for an IVF treatment. When 50 women have completed the questionnaire a&#xD;
      standardized communication protocol will be enrolled. Once all midwives are trained, 50 other&#xD;
      IVF patients will be asked to complete the slightly adapted post questionnaire.The data from&#xD;
      both questionnaires will be compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>How do patients evaluate the communication by the midwife in anticipation of the IVF treatment cycle?</measure>
    <time_frame>About 20 weeks counting from the launch of each questionnaire or earlier if the target of 50 patients is reached sooner</time_frame>
    <description>Self created questionnaire (no scale)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Communication</condition>
  <condition>IVF</condition>
  <arm_group>
    <arm_group_label>PRE implementation communication protocol</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>POST implementation communication protocol</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>A digital questionnaire to evaluate the communication by midwives will be send out to IVF patients</description>
    <arm_group_label>POST implementation communication protocol</arm_group_label>
    <arm_group_label>PRE implementation communication protocol</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Dutch-speaking women who are about to start an IVF treatment at our department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who are about to start an IVF treatment at our department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-Dutch speaking&#xD;
&#xD;
          -  women who are counseled by one of the midwives involved in the design of this study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04420169
org study id: B670201627388
nct id: NCT04420169
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Prospective
measure: 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
description: Self created questionnaire (no scale)
arm group label: PRE implementation communication protocol
arm group label: POST implementation communication protocol
intervention type: Other
intervention name: Questionnaire
description: A digital questionnaire to evaluate the communication by midwives will be send out to IVF patients
arm group label: POST implementation communication protocol
arm group label: PRE implementation communication protocol
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: No