<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/NCT04488211</url>
  </required_header>
  <id_info>
    <org_study_id>IVM Survey V2 04062020</org_study_id>
    <nct_id>NCT04488211</nct_id>
  </id_info>
  <brief_title>IVM Survey Among Reproductive Medicine Specialists</brief_title>
  <official_title>Survey of Fertility Specialists' Knowledge of, Experience With, and Attitudes Toward the Use of in Vitro Maturation of Oocytes in Reproductive Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CooperSurgical Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although IVM as a laboratory technology in reproductive medicine has existed for many&#xD;
      decades, there is a lack of well-designed studies comparing the efficiency and the patient&#xD;
      satisfaction related to IVM as compared to standard ovarian stimulation for IVF. In view of&#xD;
      this, and in order to identify unmet needs of fertility specialists with regard to the&#xD;
      application of IVM, the investigator developed the idea of a worldwide web-based survey&#xD;
      analysis of fertility specialists' insights and experiences regarding IVM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The IVM survey will be structured as a series of open questions and multiple-choice&#xD;
      questions. In most of the questions, a single answer will be required by participants. A&#xD;
      small number of questions will allow multiple answers. The survey will be web-based.&#xD;
      Invitations to participate in the survey will be emailed on three occasions to selected&#xD;
      fertility specialists worldwide who are affiliated to a public or private fertility clinic.&#xD;
      Clinics will be identified based on whether they have worked with IVM previously but stopped,&#xD;
      and clinics with appropriate size to offer IVM competence. When no response is obtained from&#xD;
      selected fertility specialists, e-mails will be sent to affiliated colleagues working at the&#xD;
      same fertility clinic. When analyzing the survey results, care will be taken to analyse the&#xD;
      responses per fertility clinic, as responses from different fertility specialists working in&#xD;
      the same fertility clinic should be avoided. Results will be analysed using a method that&#xD;
      assigns equal weight per clinic and a method that weights clinic responses based on treatment&#xD;
      volume (number of IVF cycles).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Name of the measurement: Application of in vitro maturation (IVM) of oocytes as a laboratory tool</measure>
    <time_frame>1 month</time_frame>
    <description>Measurement tool: questionnaire; unit of measure: % of respondents who use oocyte in vitro maturation in the laboratory;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Name of the measurement: Appreciation of IVM as a laboratory technique</measure>
    <time_frame>1 month</time_frame>
    <description>Measurement tool: questionnaire; unit of measure: % of respondents who believe there is a role for IVM in the ART (assisted reproductive technology ) clinic</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Name of the measurement: Annual number of egg retrievals for IVM</measure>
    <time_frame>1 month</time_frame>
    <description>Measurement tool: questionnaire; unit of measure: number</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>IVM</condition>
  <arm_group>
    <arm_group_label>Prospective survey respondents</arm_group_label>
    <description>Invitations to participate in the survey will be emailed on three occasions to selected fertility specialists worldwide who are affiliated to a public or private fertility clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>The IVM survey will be structured as a series of open questions and multiple-choice questions.</description>
    <arm_group_label>Prospective survey respondents</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Fertility specialists around the globe who are affiliated to a public or private fertility&#xD;
        clinic. Clinics will be identified based on whether they have worked with IVM previously&#xD;
        but stopped, and clinics with appropriate size to offer IVM competence.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IVF clinics that have worked with IVM previously but stopped&#xD;
&#xD;
          -  clinics with appropriate size to offer IVM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michel De Vos</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</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/NCT04488211
org study id: IVM Survey V2 04062020
nct id: NCT04488211
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although IVM as a laboratory technology in reproductive medicine has existed for many
      decades, there is a lack of well-designed studies comparing the efficiency and the patient
      satisfaction related to IVM as compared to standard ovarian stimulation for IVF. In view of
      this, and in order to identify unmet needs of fertility specialists with regard to the
      application of IVM, the investigator developed the idea of a worldwide web-based survey
      analysis of fertility specialists' insights and experiences regarding IVM.
The IVM survey will be structured as a series of open questions and multiple-choice
      questions. In most of the questions, a single answer will be required by participants. A
      small number of questions will allow multiple answers. The survey will be web-based.
      Invitations to participate in the survey will be emailed on three occasions to selected
      fertility specialists worldwide who are affiliated to a public or private fertility clinic.
      Clinics will be identified based on whether they have worked with IVM previously but stopped,
      and clinics with appropriate size to offer IVM competence. When no response is obtained from
      selected fertility specialists, e-mails will be sent to affiliated colleagues working at the
      same fertility clinic. When analyzing the survey results, care will be taken to analyse the
      responses per fertility clinic, as responses from different fertility specialists working in
      the same fertility clinic should be avoided. Results will be analysed using a method that
      assigns equal weight per clinic and a method that weights clinic responses based on treatment
      volume (number of IVF cycles).
observational model: Cohort
time perspective: Prospective
measure: Name of the measurement: Application of in vitro maturation (IVM) of oocytes as a laboratory tool
time frame: 1 month
description: Measurement tool: questionnaire; unit of measure: % of respondents who use oocyte in vitro maturation in the laboratory;
measure: Name of the measurement: Appreciation of IVM as a laboratory technique
time frame: 1 month
description: Measurement tool: questionnaire; unit of measure: % of respondents who believe there is a role for IVM in the ART (assisted reproductive technology ) clinic
measure: Name of the measurement: Annual number of egg retrievals for IVM
time frame: 1 month
description: Measurement tool: questionnaire; unit of measure: number
arm group label: Prospective survey respondents
description: Invitations to participate in the survey will be emailed on three occasions to selected fertility specialists worldwide who are affiliated to a public or private fertility clinic.
intervention type: Other
intervention name: Survey
description: The IVM survey will be structured as a series of open questions and multiple-choice questions.
arm group label: Prospective survey respondents
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Michel De Vos
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: No