<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/NCT02979990</url>
  </required_header>
  <id_info>
    <org_study_id>16-20821</org_study_id>
    <nct_id>NCT02979990</nct_id>
  </id_info>
  <brief_title>Learning From Online Video Education for Controlled Ovarian Stimulation</brief_title>
  <acronym>LOVE</acronym>
  <official_title>Learning From Online Video Education for Controlled Ovarian Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The Learning from Online Video Education (LOVE) study seeks to determine if online&#xD;
      instructional videos on how to administer medication needed for in vitro fertilization (IVF)&#xD;
      help improve the quality of life and reduce stress during the IVF process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Learning from Online Video Education (LOVE) is a randomized controlled trial that seeks&#xD;
      to determine the effect of instructional online videos on medication administration on&#xD;
      psychological well being during controlled ovarian stimulation.&#xD;
&#xD;
      The investigators hypothesize that usage of online instructional videos by women undergoing&#xD;
      their first cycle of controlled ovarian stimulation for in vitro fertilization or oocyte&#xD;
      cryopreservation improves measures of psychological well-being (Infertility Self Efficacy&#xD;
      Scale, FertiQoL-T and Perceived stress scores) when compared to subjects that do not have&#xD;
      access to this educational resource.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">November 27, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infertility Self Efficacy Scale</measure>
    <time_frame>The infertility self efficacy scale score will be collected up to two weeks after egg retrieval</time_frame>
    <description>Short questionnaire to determine a subjects self efficacy related to fertility treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FertiQoL-T score</measure>
    <time_frame>The Ferti-QoL-T score will be collected up to two weeks after egg retrieval</time_frame>
    <description>The FertiQoL-T questionnaire is a previously validated instrument to assess ones quality of life as it relates to the administration of fertility medication administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress score</measure>
    <time_frame>The perceived stress score will be collected up to two weeks after egg retrieval</time_frame>
    <description>This is a well validated psychological instrument used to measure one's perception of stress</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">368</enrollment>
  <condition>Self Efficacy</condition>
  <arm_group>
    <arm_group_label>Control Video</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will have access to general videos on the in vitro fertilization process. They will not have access to instructional videos related to the administration of controlled ovarian stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be asked to view instructional videos related to the administration of controlled ovarian stimulation medication during their own controlled ovarian stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Instructional Video</intervention_name>
    <description>The experimental group will be asked to view a set of videos that demonstrate proper usage of controlled ovarian stimulation medication. They will have the opportunity to review instructional videos as needed throughout the ovarian stimulation process.</description>
    <arm_group_label>Experimental Video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Video</intervention_name>
    <description>The control group will have access to a video about the IVF process</description>
    <arm_group_label>Control Video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing first controlled ovarian stimulation cycle at the time of enrollment&#xD;
&#xD;
          -  Has internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had prior controlled ovarian stimulation cycle&#xD;
&#xD;
          -  Does not have internet access&#xD;
&#xD;
          -  Declines in person IVF medication teaching session&#xD;
&#xD;
          -  Treating physician requests that patient not be approached for participation (any&#xD;
             reason)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather Huddleston, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gameiro S, Boivin J, Peronace L, Verhaak CM. Why do patients discontinue fertility treatment? A systematic review of reasons and predictors of discontinuation in fertility treatment. Hum Reprod Update. 2012 Nov-Dec;18(6):652-69. doi: 10.1093/humupd/dms031. Epub 2012 Aug 6.</citation>
    <PMID>22869759</PMID>
  </reference>
  <reference>
    <citation>Omurtag K, Jimenez PT, Ratts V, Odem R, Cooper AR. The ART of social networking: how SART member clinics are connecting with patients online. Fertil Steril. 2012 Jan;97(1):88-94. doi: 10.1016/j.fertnstert.2011.10.001. Epub 2011 Nov 14.</citation>
    <PMID>22088209</PMID>
  </reference>
  <reference>
    <citation>Cousineau TM, Lord SE, Seibring AR, Corsini EA, Viders JC, Lakhani SR. A multimedia psychosocial support program for couples receiving infertility treatment: a feasibility study. Fertil Steril. 2004 Mar;81(3):532-8. doi: 10.1016/j.fertnstert.2003.08.021.</citation>
    <PMID>15037398</PMID>
  </reference>
  <reference>
    <citation>Turner K, Reynolds-May MF, Zitek EM, Tisdale RL, Carlisle AB, Westphal LM. Stress and anxiety scores in first and repeat IVF cycles: a pilot study. PLoS One. 2013 May 23;8(5):e63743. doi: 10.1371/journal.pone.0063743. Print 2013.</citation>
    <PMID>23717472</PMID>
  </reference>
  <reference>
    <citation>Garcia D, Vassena R, Prat A, Vernaeve V. Increasing fertility knowledge and awareness by tailored education: a randomized controlled trial. Reprod Biomed Online. 2016 Jan;32(1):113-20. doi: 10.1016/j.rbmo.2015.10.008. Epub 2015 Oct 30.</citation>
    <PMID>26611499</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>infertility</keyword>
  <keyword>education</keyword>
  <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/NCT02979990
org study id: 16-20821
nct id: NCT02979990
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Learning from Online Video Education (LOVE) study seeks to determine if online
      instructional videos on how to administer medication needed for in vitro fertilization (IVF)
      help improve the quality of life and reduce stress during the IVF process.
The Learning from Online Video Education (LOVE) is a randomized controlled trial that seeks
      to determine the effect of instructional online videos on medication administration on
      psychological well being during controlled ovarian stimulation.

      The investigators hypothesize that usage of online instructional videos by women undergoing
      their first cycle of controlled ovarian stimulation for in vitro fertilization or oocyte
      cryopreservation improves measures of psychological well-being (Infertility Self Efficacy
      Scale, FertiQoL-T and Perceived stress scores) when compared to subjects that do not have
      access to this educational resource.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Infertility Self Efficacy Scale
time frame: The infertility self efficacy scale score will be collected up to two weeks after egg retrieval
description: Short questionnaire to determine a subjects self efficacy related to fertility treatment
measure: FertiQoL-T score
time frame: The Ferti-QoL-T score will be collected up to two weeks after egg retrieval
description: The FertiQoL-T questionnaire is a previously validated instrument to assess ones quality of life as it relates to the administration of fertility medication administration.
measure: Perceived stress score
time frame: The perceived stress score will be collected up to two weeks after egg retrieval
description: This is a well validated psychological instrument used to measure one's perception of stress
arm group label: Control Video
arm group type: Placebo Comparator
description: Subjects will have access to general videos on the in vitro fertilization process. They will not have access to instructional videos related to the administration of controlled ovarian stimulation.
arm group label: Experimental Video
arm group type: Experimental
description: Subjects will be asked to view instructional videos related to the administration of controlled ovarian stimulation medication during their own controlled ovarian stimulation
intervention type: Other
intervention name: Instructional Video
description: The experimental group will be asked to view a set of videos that demonstrate proper usage of controlled ovarian stimulation medication. They will have the opportunity to review instructional videos as needed throughout the ovarian stimulation process.
arm group label: Experimental Video
intervention type: Other
intervention name: Control Video
description: The control group will have access to a video about the IVF process
arm group label: Control Video
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 43 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heather Huddleston, M.D.
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: Gameiro S, Boivin J, Peronace L, Verhaak CM. Why do patients discontinue fertility treatment? A systematic review of reasons and predictors of discontinuation in fertility treatment. Hum Reprod Update. 2012 Nov-Dec;18(6):652-69. doi: 10.1093/humupd/dms031. Epub 2012 Aug 6.
PMID: 22869759
citation: Omurtag K, Jimenez PT, Ratts V, Odem R, Cooper AR. The ART of social networking: how SART member clinics are connecting with patients online. Fertil Steril. 2012 Jan;97(1):88-94. doi: 10.1016/j.fertnstert.2011.10.001. Epub 2011 Nov 14.
PMID: 22088209
citation: Cousineau TM, Lord SE, Seibring AR, Corsini EA, Viders JC, Lakhani SR. A multimedia psychosocial support program for couples receiving infertility treatment: a feasibility study. Fertil Steril. 2004 Mar;81(3):532-8. doi: 10.1016/j.fertnstert.2003.08.021.
PMID: 15037398
citation: Turner K, Reynolds-May MF, Zitek EM, Tisdale RL, Carlisle AB, Westphal LM. Stress and anxiety scores in first and repeat IVF cycles: a pilot study. PLoS One. 2013 May 23;8(5):e63743. doi: 10.1371/journal.pone.0063743. Print 2013.
PMID: 23717472
citation: Garcia D, Vassena R, Prat A, Vernaeve V. Increasing fertility knowledge and awareness by tailored education: a randomized controlled trial. Reprod Biomed Online. 2016 Jan;32(1):113-20. doi: 10.1016/j.rbmo.2015.10.008. Epub 2015 Oct 30.
PMID: 26611499
responsible party type: Sponsor
sharing ipd: No