<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/NCT04419740</url>
  </required_header>
  <id_info>
    <org_study_id>EMOT-IVF</org_study_id>
    <nct_id>NCT04419740</nct_id>
  </id_info>
  <brief_title>Impact of a Mindfulness Intervention on Infertile Women Undergoing Assisted Reproductive Technique Treatments</brief_title>
  <acronym>EMOT-IVF</acronym>
  <official_title>What is the Impact of an E-tool Based Mindfulness Intervention on Psychological Outcomes Compared to no Intervention in Infertile Women Undergoing Assisted Reproductive Technique Treatments: A Randomized Controlled Study?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</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>
      Infertility and its treatments can have a significant impact on women's psychological health.&#xD;
      Anxiety has a negative impact on quality of life during treatment and can lead to withdrawal&#xD;
      of care. the investigators would like to test the effectiveness of an application available&#xD;
      via the Internet that offers daily exercises such as mindfulness meditation. Women in the&#xD;
      &quot;treatment&quot; group will be instructed to practice meditation exercises using the 15-minute&#xD;
      daily application during in vitro fertilization treatment until pregnancy testing. Women in&#xD;
      the control group will have the standard care of the centre. The investigators will measure&#xD;
      the effectiveness of the intervention on anxiety, depression, quality of life and mindfulness&#xD;
      aspects. The investigators will also assess the impact on the chances of pregnancy and&#xD;
      stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infertility is an unexpected and stressful life with emotional, social and sexual&#xD;
      repercussions. Women undergoing assisted reproductive techniques (ART) exhibit high anxiety&#xD;
      and/or depression scores during the pre-treatment period, during the course of treatment and&#xD;
      during the 2 weeks waiting-time for the pregnancy test.&#xD;
&#xD;
      The impact of psychological distress on ART outcomes is debated. Several studies report a&#xD;
      negative impact of stress on pregnancy rates after IVF whereas two meta-analyses report&#xD;
      inconclusive results regarding the association between emotional distress and pregnancy&#xD;
      outcomes after ART.&#xD;
&#xD;
      The success rates of ART, which are highly dependent on the woman's age, are low in women in&#xD;
      their late reproductive years with the need of several ART treatments to achieve pregnancy.&#xD;
      Moreover, ART is often the last resort treatment in couples that have undergone infertility&#xD;
      investigations and other first-line treatments such as surgery, ovulation induction and/or&#xD;
      stimulation with intra-uterine insemination. Couple need resilience in order to undergo&#xD;
      repeated treatments. Psychological distress therefore has an impact on cumulative pregnancy&#xD;
      rates over several ART treatments because of premature treatment discontinuation. Depressive&#xD;
      symptoms at baseline have been shown to predict treatment &quot;dropout&quot; after only one cycle.&#xD;
&#xD;
      Preliminary evidence suggests that mind-body interventions, including mindfulness-based&#xD;
      interventions and yoga, may be effective in reducing mental health difficulties such as&#xD;
      anxiety and depression in infertile women undergoing treatments.&#xD;
&#xD;
      The aim of the investigators was to develop a psychological self-help tool using modern&#xD;
      technological means in line with the recent Femtech (female technology) developments. The&#xD;
      hypothesis was that an online meditation tool would be more accessible and easier to&#xD;
      integrate into a busy schedule than standard programs that require weekly attendance.&#xD;
&#xD;
      In 2017, the investigators created collaboration between experts in reproductive medicine,&#xD;
      experts in mindfulness and a start-up that offers an online platform for meditation programs.&#xD;
      The investigators developed an online program of 15 meditations specifically dedicated to&#xD;
      infertile women. These meditations help women explore certain themes such as &quot;inner&#xD;
      resources&quot;, &quot;social interactions&quot;, &quot;letting go of beliefs&quot; etc. This program has been&#xD;
      available online since December 2017 and has been used by several thousand women.&#xD;
&#xD;
      The hypothesis behind the study is that &quot;mindfulness-based interventions&quot; can be delivered&#xD;
      successfully through modern technologies with a significant impact on psychological outcomes&#xD;
      and well-being. Femtech self-help online tools are used by thousands of women on a daily&#xD;
      basis but studies are lacking on their efficacy.&#xD;
&#xD;
      The aim is to conduct a randomized controlled trial on the effect of a mindfulness-based&#xD;
      intervention using the online meditation program versus standard care without intervention on&#xD;
      psychological outcomes in infertile women undergoing ART treatments.&#xD;
&#xD;
      Women in the intervention group will receive an introduction to the concept and philosophy of&#xD;
      mindfulness meditation through an online video and an exercise book. They will receive an&#xD;
      access code to the application and will have access to short guided meditations both general&#xD;
      and specific to their infertility. They will be instructed to follow the &quot;découverte&quot;&#xD;
      (discovery) program of 8 meditations of 10 minutes and then the program &quot;désir de&#xD;
      parentalité&quot; (wish to become a parent) of 15 meditations of 13 minutes each. Patients will be&#xD;
      given access to all other meditations programs on the application and instructed to meditate&#xD;
      with the program for at least 10-15 minutes on a daily basis using the e-tool for 1 month.&#xD;
      The practice of meditation will be monitored by the number of connections to the applications&#xD;
      and the time spent on the exercises. Women in the control group will have the standard care&#xD;
      of the centre. The investigators will measure the effectiveness of the intervention on&#xD;
      anxiety (State trait anxiety index, STAI), depression (Beck depression inventory, BDI),&#xD;
      quality of life during ART treatments (Fertility quality of life tool, Fertiqol) and&#xD;
      mindfulness aspects (Five facet mindfulness questionnaire, FFMQ). The investigators will also&#xD;
      measure the impact of the intervention on biological stress measured by hair cortisol&#xD;
      concentration. Finally, the investigators will assess the impact on the chances of pregnancy&#xD;
      and on treatment discontinuation after 1 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety state</measure>
    <time_frame>1 month</time_frame>
    <description>The primary aim of the study is to evaluate the effect of an e-tool based intervention versus standard care without intervention on anxiety state measured by the French version of state trait anxiety index in infertile women undergoing ART.&#xD;
State trait anxiety index state scores will be evaluated by completion of a questionnaire at 3 time points: baseline, at the time of the oocyte retrieval, on the day before the pregnancy test (before the results).&#xD;
A score between 31 and 36 is considered as normal score.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>Mindfulness based psychological intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients allocated to the intervention group will receive an email with a link to a video and a pdf document. The video and the pdf document will introduce them to the principles and the practice of mindfulness. They will also receive an access code to an e-tool valid for 1 month. On this e-tool the patient will have access to short guided meditations both general and specific to infertility. They will be instructed to follow the &quot;découverte&quot; (discovery) program of 8 meditations of 10 minutes and then the program &quot;désir de parentalité (wish to become a parent) of 13 minutes 15 meditations of 13 minutes each. Patients will be given access to all other meditations programs of PetitBambou and instructed to meditate with the program for at least 10-15 minutes on a daily basis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will have no additional intervention and will receive standard care in the institution. Women in all 3 study sites have access to counselling/psychological support with a trained professional before treatment initiation. During that consultation coping and stress reduction strategies are discussed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness based psychological intervention</intervention_name>
    <description>Women in the intervention group will have to use an application during 1 month. They will do meditation during 15 minutes each day.</description>
    <arm_group_label>Mindfulness based psychological intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants fulfilling all of the following inclusion criteria are eligible for the study:&#xD;
&#xD;
          -  French-speaking&#xD;
&#xD;
          -  Women between the ages of 18-42 years&#xD;
&#xD;
          -  Scheduled for the first IVF treatment in HUG/CHUV/CPMA Lausanne&#xD;
&#xD;
          -  Access to a computer/smartphone/tablet with access to internet and a valid Email&#xD;
             address&#xD;
&#xD;
          -  Informed Consent as documented by her signature on the form (Appendix Informed Consent&#xD;
             Form)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychotropic medication&#xD;
&#xD;
          -  Ongoing psychiatric/psychological treatment&#xD;
&#xD;
          -  Known severe psychiatric co-morbidity&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 11, 2019</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Isabelle Streuli</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <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/NCT04419740
org study id: EMOT-IVF
nct id: NCT04419740
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Infertility and its treatments can have a significant impact on women's psychological health.
      Anxiety has a negative impact on quality of life during treatment and can lead to withdrawal
      of care. the investigators would like to test the effectiveness of an application available
      via the Internet that offers daily exercises such as mindfulness meditation. Women in the
      "treatment" group will be instructed to practice meditation exercises using the 15-minute
      daily application during in vitro fertilization treatment until pregnancy testing. Women in
      the control group will have the standard care of the centre. The investigators will measure
      the effectiveness of the intervention on anxiety, depression, quality of life and mindfulness
      aspects. The investigators will also assess the impact on the chances of pregnancy and
      stress.
Infertility is an unexpected and stressful life with emotional, social and sexual
      repercussions. Women undergoing assisted reproductive techniques (ART) exhibit high anxiety
      and/or depression scores during the pre-treatment period, during the course of treatment and
      during the 2 weeks waiting-time for the pregnancy test.

      The impact of psychological distress on ART outcomes is debated. Several studies report a
      negative impact of stress on pregnancy rates after IVF whereas two meta-analyses report
      inconclusive results regarding the association between emotional distress and pregnancy
      outcomes after ART.

      The success rates of ART, which are highly dependent on the woman's age, are low in women in
      their late reproductive years with the need of several ART treatments to achieve pregnancy.
      Moreover, ART is often the last resort treatment in couples that have undergone infertility
      investigations and other first-line treatments such as surgery, ovulation induction and/or
      stimulation with intra-uterine insemination. Couple need resilience in order to undergo
      repeated treatments. Psychological distress therefore has an impact on cumulative pregnancy
      rates over several ART treatments because of premature treatment discontinuation. Depressive
      symptoms at baseline have been shown to predict treatment "dropout" after only one cycle.

      Preliminary evidence suggests that mind-body interventions, including mindfulness-based
      interventions and yoga, may be effective in reducing mental health difficulties such as
      anxiety and depression in infertile women undergoing treatments.

      The aim of the investigators was to develop a psychological self-help tool using modern
      technological means in line with the recent Femtech (female technology) developments. The
      hypothesis was that an online meditation tool would be more accessible and easier to
      integrate into a busy schedule than standard programs that require weekly attendance.

      In 2017, the investigators created collaboration between experts in reproductive medicine,
      experts in mindfulness and a start-up that offers an online platform for meditation programs.
      The investigators developed an online program of 15 meditations specifically dedicated to
      infertile women. These meditations help women explore certain themes such as "inner
      resources", "social interactions", "letting go of beliefs" etc. This program has been
      available online since December 2017 and has been used by several thousand women.

      The hypothesis behind the study is that "mindfulness-based interventions" can be delivered
      successfully through modern technologies with a significant impact on psychological outcomes
      and well-being. Femtech self-help online tools are used by thousands of women on a daily
      basis but studies are lacking on their efficacy.

      The aim is to conduct a randomized controlled trial on the effect of a mindfulness-based
      intervention using the online meditation program versus standard care without intervention on
      psychological outcomes in infertile women undergoing ART treatments.

      Women in the intervention group will receive an introduction to the concept and philosophy of
      mindfulness meditation through an online video and an exercise book. They will receive an
      access code to the application and will have access to short guided meditations both general
      and specific to their infertility. They will be instructed to follow the "découverte"
      (discovery) program of 8 meditations of 10 minutes and then the program "désir de
      parentalité" (wish to become a parent) of 15 meditations of 13 minutes each. Patients will be
      given access to all other meditations programs on the application and instructed to meditate
      with the program for at least 10-15 minutes on a daily basis using the e-tool for 1 month.
      The practice of meditation will be monitored by the number of connections to the applications
      and the time spent on the exercises. Women in the control group will have the standard care
      of the centre. The investigators will measure the effectiveness of the intervention on
      anxiety (State trait anxiety index, STAI), depression (Beck depression inventory, BDI),
      quality of life during ART treatments (Fertility quality of life tool, Fertiqol) and
      mindfulness aspects (Five facet mindfulness questionnaire, FFMQ). The investigators will also
      measure the impact of the intervention on biological stress measured by hair cortisol
      concentration. Finally, the investigators will assess the impact on the chances of pregnancy
      and on treatment discontinuation after 1 month.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anxiety state
time frame: 1 month
description: The primary aim of the study is to evaluate the effect of an e-tool based intervention versus standard care without intervention on anxiety state measured by the French version of state trait anxiety index in infertile women undergoing ART.
State trait anxiety index state scores will be evaluated by completion of a questionnaire at 3 time points: baseline, at the time of the oocyte retrieval, on the day before the pregnancy test (before the results).
A score between 31 and 36 is considered as normal score.
arm group label: Mindfulness based psychological intervention
arm group type: Experimental
description: Patients allocated to the intervention group will receive an email with a link to a video and a pdf document. The video and the pdf document will introduce them to the principles and the practice of mindfulness. They will also receive an access code to an e-tool valid for 1 month. On this e-tool the patient will have access to short guided meditations both general and specific to infertility. They will be instructed to follow the "découverte" (discovery) program of 8 meditations of 10 minutes and then the program "désir de parentalité (wish to become a parent) of 13 minutes 15 meditations of 13 minutes each. Patients will be given access to all other meditations programs of PetitBambou and instructed to meditate with the program for at least 10-15 minutes on a daily basis.
arm group label: Standard care
arm group type: No Intervention
description: The control group will have no additional intervention and will receive standard care in the institution. Women in all 3 study sites have access to counselling/psychological support with a trained professional before treatment initiation. During that consultation coping and stress reduction strategies are discussed.
intervention type: Behavioral
intervention name: Mindfulness based psychological intervention
description: Women in the intervention group will have to use an application during 1 month. They will do meditation during 15 minutes each day.
arm group label: Mindfulness based psychological intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Isabelle Streuli
investigator title: Principal investigator
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: No