<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/NCT01714882</url>
  </required_header>
  <id_info>
    <org_study_id>12-007272</org_study_id>
    <nct_id>NCT01714882</nct_id>
  </id_info>
  <brief_title>Stress Management for Couples Undergoing In Vitro Fertilization (IVF)</brief_title>
  <official_title>Stress Management for Couples With Infertility Undergoing In Vitro Fertilization (IVF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amit Sood</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are trying to determine stress management strategies in couples undergoing&#xD;
      In Vitro Fertilization (IVF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are trying to determine two different stress management techniques in&#xD;
      couples undergoing IVF. One arm will be randomized to learning these techniques by themselves&#xD;
      by watching and following instructions on a digital video disc (DVD). The other arm will have&#xD;
      an in-person class that will teach the couples different stress reduction techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Scores from questionnaires from baseline to 6 and then 12 weeks</measure>
    <time_frame>Baseline, 6 and 12 weeks after randomization</time_frame>
    <description>Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Pregnancy rate</measure>
    <time_frame>12 months after randomization</time_frame>
    <description>Clinical pregnancy rate: which is defined as seeing a gestational sac in the uterus with a fetal pole that has a heart beat.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical or biochemical miscarriage</measure>
    <time_frame>12 months after randomization</time_frame>
    <description>Miscarriage will be defined as a biochemical or clinical miscarriage. A biochemical miscarriage will include a rise and then subsequent fall in beta human chorionic gonadotrophin (BhCG) to less than 5 IU/L. A clinical miscarriage will be defined as vaginal bleeding with passage of products of conception recognized as products of conception by histopathology.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Stress Management &amp; Resiliency Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stress Management DVD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The couples in this group will receive a Mayo Clinic Stress Management DVD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stress Management &amp; Resiliency Training</intervention_name>
    <description>The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.</description>
    <arm_group_label>Stress Management &amp; Resiliency Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stress Management DVD</intervention_name>
    <description>The couples in this group will receive a Mayo Clinic Stress Management DVD.</description>
    <arm_group_label>Stress Management DVD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with clinical infertility, either primary or secondary, who are recommended for&#xD;
             IVF for the first time as part of their treatment for infertility&#xD;
&#xD;
          -  Women with a partner, and both are willing to provide consent for study participation&#xD;
             as a couple&#xD;
&#xD;
          -  Couples that can be reached by telephone for follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women less than 18 years of age&#xD;
&#xD;
          -  Women equal or greater than 40 years of age&#xD;
&#xD;
          -  Women with a history of recurrent pregnancy loss&#xD;
&#xD;
          -  History of current or recent psychotic episode within past 6 months for either the&#xD;
             woman or her partner&#xD;
&#xD;
          -  Couples needing a interpreter for their clinical encounter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amit Sood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zaraq Khan, MBBS</last_name>
    <role>Study Chair</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>November 5, 2015</last_update_submitted>
  <last_update_submitted_qc>November 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Amit Sood</investigator_full_name>
    <investigator_title>Associate Professor of Medicine, Consultant - General Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>Infertility</keyword>
  <keyword>In Vitro Fertilization (IVF)</keyword>
  <keyword>Stress Management</keyword>
  <keyword>Stress Reduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <!-- 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/NCT01714882
org study id: 12-007272
nct id: NCT01714882
lead sponsor: 
has dmc: No
The investigators are trying to determine stress management strategies in couples undergoing
      In Vitro Fertilization (IVF).
The investigators are trying to determine two different stress management techniques in
      couples undergoing IVF. One arm will be randomized to learning these techniques by themselves
      by watching and following instructions on a digital video disc (DVD). The other arm will have
      an in-person class that will teach the couples different stress reduction techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change of Scores from questionnaires from baseline to 6 and then 12 weeks
time frame: Baseline, 6 and 12 weeks after randomization
description: Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.
measure: Clinical Pregnancy rate
time frame: 12 months after randomization
description: Clinical pregnancy rate: which is defined as seeing a gestational sac in the uterus with a fetal pole that has a heart beat.
measure: Clinical or biochemical miscarriage
time frame: 12 months after randomization
description: Miscarriage will be defined as a biochemical or clinical miscarriage. A biochemical miscarriage will include a rise and then subsequent fall in beta human chorionic gonadotrophin (BhCG) to less than 5 IU/L. A clinical miscarriage will be defined as vaginal bleeding with passage of products of conception recognized as products of conception by histopathology.
arm group label: Stress Management & Resiliency Training
arm group type: Experimental
description: The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.
arm group label: Stress Management DVD
arm group type: Active Comparator
description: The couples in this group will receive a Mayo Clinic Stress Management DVD.
intervention type: Behavioral
intervention name: Stress Management & Resiliency Training
description: The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.
arm group label: Stress Management & Resiliency Training
intervention type: Behavioral
intervention name: Stress Management DVD
description: The couples in this group will receive a Mayo Clinic Stress Management DVD.
arm group label: Stress Management DVD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
last name: Amit Sood, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Zaraq Khan, MBBS
role: Study Chair
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Amit Sood
investigator title: Associate Professor of Medicine, Consultant - General Internal Medicine
mesh term: Infertility