<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/NCT01701011</url>
  </required_header>
  <id_info>
    <org_study_id>PRCI study</org_study_id>
    <nct_id>NCT01701011</nct_id>
  </id_info>
  <brief_title>Coping Intervention After Embryo Transfer</brief_title>
  <official_title>Study of the Effectiveness of a Coping Selfhelp Intervention for Women in the Waiting Period After an Embryo Transfer During an IVF/ISCI Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bart CJM Fauser</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background of the study:&#xD;
&#xD;
      Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman&#xD;
      and her partner. Most stressful for the couple is waiting for the result of the treatment,&#xD;
      the period after the embryotransfer until the pregnancy test or menstruation and an&#xD;
      unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples&#xD;
      during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp&#xD;
      copingintervention has been developed based on the stress theory of Lazarus for women to use&#xD;
      at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal.&#xD;
      Research has demonstrated that using this copingstyle can have a positive impact in health&#xD;
      related circumstances.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective of the study:&#xD;
&#xD;
      To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or&#xD;
      ICSI treatment in the UMCU during the waitingperiod after an embryotransfer.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      In this research a randomised controlled trial (RCT) will be used for three groups. The&#xD;
      choice for three groups has been based on earlier research with a daily record keeping (DRK).&#xD;
      The DRK is a daily measurement for emotions, copingstyle and physical complaints. Previous&#xD;
      research with the DRK showed an increase of anxiety. More research must be done of the impact&#xD;
      of the DRK. Group 1: Positive Reappraisal Coping Intervention (PRCI) &amp; DRK &amp; questionnaires&#xD;
      Group 2: DRK &amp; questionnaires Group 3: Standard care &amp; questionnaires&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Patients undergoing an IVF or ICSI treatment in the UMCU.&#xD;
&#xD;
      Intervention (if applicable):&#xD;
&#xD;
      A selfhelp coping intervention&#xD;
&#xD;
      Primary study parameters/outcome of the study:&#xD;
&#xD;
      Anxiety&#xD;
&#xD;
      Secondary study parameters/outcome of the study (if applicable):&#xD;
&#xD;
      Risk of emotional problems copingstyle depression vital pregnancy quality of life&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness (if applicable):&#xD;
&#xD;
      Using the coping intervention may reduce anxiety for the patient. The use of this instrument&#xD;
      is not a burden for patients. The burden for patients is to complete questionnaires before,&#xD;
      during and six weeks after the embryotransfer. Partners are asked to fill in a questionnaire&#xD;
      at three times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">377</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>PRCI-monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coping intervention, Daily Record Keeping, Questionnaires</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Questionnaires</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monitoring control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>DRK and Questionnaires</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coping intervention</intervention_name>
    <description>Positive reappraisal coping intervention</description>
    <arm_group_label>PRCI-monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient in IVF/ICSI treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who do not speak the dutch language&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>N.S. Macklon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southampton</affiliation>
  </overall_official>
  <overall_official>
    <last_name>J Boivin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiff University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>: PO Box 85500</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://www.biomedcentral.com/content/pdf/1472-6874-13-35.pdf</url>
    <description>Article study protocol</description>
  </link>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 6, 2010</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>December 3, 2014</results_first_submitted>
  <results_first_submitted_qc>December 11, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 22, 2014</results_first_posted>
  <last_update_submitted>June 28, 2016</last_update_submitted>
  <last_update_submitted_qc>June 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>Bart CJM Fauser</investigator_full_name>
    <investigator_title>prof</investigator_title>
  </responsible_party>
  <keyword>coping</keyword>
  <keyword>intervention</keyword>
  <keyword>waiting-period</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>In the 20 months of recruitment, between October 2010 and June 2012, 1445 letters were sent to women with an invitation to the trial.</recruitment_details>
      <pre_assignment_details>Of the 565 women who replied via a letter or email, 188 (33%) were not eligible. The remaining 377 women were randomised and the 349 who had an embryo to transfer (n=119 PRCI-monitoring, n=117 monitoring-control, n=113 routine care control)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PRCI-monitoring Group</title>
          <description>Coping intervention, Daily Record Keeping, Questionnaires</description>
        </group>
        <group group_id="P2">
          <title>Monitoring-control Group</title>
          <description>Daily Record Keeping and Questionnaires</description>
        </group>
        <group group_id="P3">
          <title>Routine Care Control Group</title>
          <description>Patients receive only questionnaires</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
                <participants group_id="P2" count="126"/>
                <participants group_id="P3" count="124"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="102"/>
                <participants group_id="P3" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PRCI-monitoring Group</title>
          <description>Coping intervention, Daily Record Keeping, Questionnaires&#xD;
Coping intervention, Daily Record Keeping, Questionnaires :</description>
        </group>
        <group group_id="B2">
          <title>Monitoring-control Group</title>
          <description>DRK and Questionnaires&#xD;
Coping intervention, Daily Record Keeping, Questionnaires :</description>
        </group>
        <group group_id="B3">
          <title>Routine Care Control Group</title>
          <description>Questionnaires&#xD;
Coping intervention, Daily Record Keeping, Questionnaires :</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="127"/>
            <count group_id="B2" value="126"/>
            <count group_id="B3" value="124"/>
            <count group_id="B4" value="377"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.9" spread="4.7"/>
                    <measurement group_id="B2" value="34.6" spread="4.7"/>
                    <measurement group_id="B3" value="34.8" spread="5.0"/>
                    <measurement group_id="B4" value="34.8" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="124"/>
                    <measurement group_id="B4" value="377"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="124"/>
                    <measurement group_id="B4" value="377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Anxiety</title>
        <description>The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.</description>
        <time_frame>T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer</time_frame>
        <population>Only in women with embryo transfer</population>
        <group_list>
          <group group_id="O1">
            <title>PRCI-monitoring Group</title>
            <description>Coping intervention, Daily Record Keeping, Questionnaires</description>
          </group>
          <group group_id="O2">
            <title>Monitoring-control Group</title>
            <description>Daily Record Keeping and Questionnaires</description>
          </group>
          <group group_id="O3">
            <title>Routine Care Control Group</title>
            <description>patients receive questionnaires</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety</title>
          <description>The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.</description>
          <population>Only in women with embryo transfer</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
                <count group_id="O2" value="117"/>
                <count group_id="O3" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.279" spread="0.242"/>
                    <measurement group_id="O2" value="6.223" spread="0.243"/>
                    <measurement group_id="O3" value="6.095" spread="0.251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.302" spread="0.269"/>
                    <measurement group_id="O2" value="7.526" spread="0.249"/>
                    <measurement group_id="O3" value="8.175" spread="0.272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.798" spread="0.279"/>
                    <measurement group_id="O2" value="5.571" spread="0.262"/>
                    <measurement group_id="O3" value="6.317" spread="0.288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the primary outcome, anxiety. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>To test the difference in psychological well-being between three groups with a power of 95%,a ¼ 0.05 and a medium effect size ( f ¼ 0.25), a total of 297 participants were required (99 patients per group). Taking into account a 20% attrition rate, at least 124 women had to be recruited in each group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression</title>
        <description>The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.</description>
        <time_frame>T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer</time_frame>
        <population>Only in women with embryo transfer</population>
        <group_list>
          <group group_id="O1">
            <title>PRCI-monitoring Group</title>
            <description>Coping intervention, Daily Record Keeping, Questionnaires</description>
          </group>
          <group group_id="O2">
            <title>Monitoring-control Group</title>
            <description>Daily Record Keeping and Questionnaires</description>
          </group>
          <group group_id="O3">
            <title>Routine Care Control Group</title>
            <description>Patients receive only questionnaires</description>
          </group>
        </group_list>
        <measure>
          <title>Depression</title>
          <description>The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.</description>
          <population>Only in women with embryo transfer</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
                <count group_id="O2" value="117"/>
                <count group_id="O3" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.389" spread="0.199"/>
                    <measurement group_id="O2" value="3.391" spread="0.201"/>
                    <measurement group_id="O3" value="3.269" spread="0.208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.709" spread="0.222"/>
                    <measurement group_id="O2" value="3.676" spread="0.206"/>
                    <measurement group_id="O3" value="4.224" spread="0.225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.983" spread="0.230"/>
                    <measurement group_id="O2" value="3.708" spread="0.216"/>
                    <measurement group_id="O3" value="3.736" spread="0.238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the secondary outcome, depression. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>PRCI-monitoring Group</title>
          <description>Coping intervention, Daily Record Keeping, Questionnaires</description>
        </group>
        <group group_id="E2">
          <title>Monitoring-control Group</title>
          <description>Daily Record Keeping and Questionnaires</description>
        </group>
        <group group_id="E3">
          <title>Routine Care Control Group</title>
          <description>patients received questionnaires</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Henrietta Ockhuijsen 1,*, Agnes van den Hoogen, Marinus Eijkemans , Nick Macklon, Jacky Boivin</name_or_title>
      <organization>UMCU</organization>
      <phone>+31307553628</phone>
      <email>h.d.l.ockhuysen@umcutrecht.nl</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01701011
org study id: PRCI study
nct id: NCT01701011
lead sponsor: 
has dmc: No
Background of the study:

      Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman
      and her partner. Most stressful for the couple is waiting for the result of the treatment,
      the period after the embryotransfer until the pregnancy test or menstruation and an
      unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples
      during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp
      copingintervention has been developed based on the stress theory of Lazarus for women to use
      at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal.
      Research has demonstrated that using this copingstyle can have a positive impact in health
      related circumstances.
Objective of the study:

      To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or
      ICSI treatment in the UMCU during the waitingperiod after an embryotransfer.

      Study design:

      In this research a randomised controlled trial (RCT) will be used for three groups. The
      choice for three groups has been based on earlier research with a daily record keeping (DRK).
      The DRK is a daily measurement for emotions, copingstyle and physical complaints. Previous
      research with the DRK showed an increase of anxiety. More research must be done of the impact
      of the DRK. Group 1: Positive Reappraisal Coping Intervention (PRCI) & DRK & questionnaires
      Group 2: DRK & questionnaires Group 3: Standard care & questionnaires

      Study population:

      Patients undergoing an IVF or ICSI treatment in the UMCU.

      Intervention (if applicable):

      A selfhelp coping intervention

      Primary study parameters/outcome of the study:

      Anxiety

      Secondary study parameters/outcome of the study (if applicable):

      Risk of emotional problems copingstyle depression vital pregnancy quality of life

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness (if applicable):

      Using the coping intervention may reduce anxiety for the patient. The use of this instrument
      is not a burden for patients. The burden for patients is to complete questionnaires before,
      during and six weeks after the embryotransfer. Partners are asked to fill in a questionnaire
      at three times.
allocation: Randomized
intervention model: Parallel Assignment
masking: Triple (Participant, Care Provider, Investigator)
measure: Anxiety
time frame: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
description: The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
measure: Depression
time frame: T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer
description: The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.
arm group label: PRCI-monitoring
arm group type: Experimental
description: Coping intervention, Daily Record Keeping, Questionnaires
arm group label: Routine care control
arm group type: No Intervention
description: Questionnaires
arm group label: Monitoring control
arm group type: No Intervention
description: DRK and Questionnaires
intervention type: Behavioral
intervention name: Coping intervention
description: Positive reappraisal coping intervention
arm group label: PRCI-monitoring
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: N.S. Macklon, MD, PhD
role: Principal Investigator
affiliation: University of Southampton
last name: J Boivin, PhD
role: Principal Investigator
affiliation: Cardiff University
facility: 
country: Netherlands
url: http://www.biomedcentral.com/content/pdf/1472-6874-13-35.pdf
description: Article study protocol
responsible party type: Sponsor-Investigator
investigator affiliation: UMC Utrecht
investigator full name: Bart CJM Fauser
investigator title: prof
mesh term: Depression
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 