<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/NCT02197936</url>
  </required_header>
  <id_info>
    <org_study_id>2014/637c</org_study_id>
    <nct_id>NCT02197936</nct_id>
  </id_info>
  <brief_title>Norwegian Adenomyosis Study III: Peristalsis</brief_title>
  <acronym>NAPPEDIII</acronym>
  <official_title>Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part III</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Departement of Biomedical Engineering, Tel Aviv University, Tel Aviv, Israel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Sor-Ost</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and&#xD;
      the role of correct peristalsis is most important for correct sperm transport towards the&#xD;
      fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time,&#xD;
      an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and&#xD;
      may also account for heavy menstrual bleedings and menstrual pain.&#xD;
&#xD;
      In this study, the uterine peristalsis of women with adenomyosis will be investigated. This&#xD;
      condition is associated to heavy menstrual bleeding, menstrual pain and infertility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The peristalsis of the non-pregnant uterus is widely investigated and the role of correct&#xD;
      peristalsis seems to be most important for correct sperm transport towards the fallopian&#xD;
      tubes and implantation of the embryo. At the same time, an impaired uterine peristalsis is&#xD;
      discussed to be the reason for lower pregnancy rates and may account for dysmenorrhea and&#xD;
      menorrhagia. The connection of impaired peristalsis and various clinical symptoms has been&#xD;
      shown for patients with e.g. leiomyoma and endometriosis, but not for women with adenomyosis,&#xD;
      though the concept seems to be widely accepted.&#xD;
&#xD;
      It has also been repeatedly postulated that impaired peristalsis interferes with implantation&#xD;
      of the embryo, yet Martinez-Conejero published a trial that showed a higher incidence of&#xD;
      miscarriage, but no effect on embryo implantation in women undergoing oocyte donation. This&#xD;
      might either indicate that the postulated effect of peristalsis is wrong or, more likely,&#xD;
      since this is a study in an IVF setting, that hormonal treatment with gonadotropin-releasing&#xD;
      hormone (GnRH)-agonist could improve implantation.&#xD;
&#xD;
      It is possible to monitor peristalsis with transvaginal ultrasound and standard patterns of&#xD;
      uterine peristalsis are defined by Jiland already in 1996.&#xD;
&#xD;
      Findings resulting from the investigations in this study may help to determine the role and&#xD;
      extent of impaired peristalsis in women with adenomyosis and possibly give new clues on&#xD;
      potential treatments, as well as fill a gap in today's knowledge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was suspended due to organisational difficulties.&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of peristaltic waves in Hz</measure>
    <time_frame>five minutes</time_frame>
    <description>Frequencies of peristalsis in patients with and without adenomyosis will be compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Altitude of peristaltic waves in mm</measure>
    <time_frame>five minutes</time_frame>
    <description>The altitude of the peristaltic waves in patients with and without adenomyosis will so be compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>direction of uterine peristalsis: antegrade, retrograde</measure>
    <time_frame>5 minutes, at time of ovulation</time_frame>
    <description>Dynamic motility characterization of the uterine peristalsis in women with adenomyosis.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3</enrollment>
  <condition>Adenomyosis</condition>
  <condition>Infertility</condition>
  <condition>Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>Peristalsis adenomyosis</arm_group_label>
    <description>with adenomyosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peristalsis control</arm_group_label>
    <description>No adenomyosis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women suffering from adenomyosis and healthy control group&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier&#xD;
             and have no other pathology of the uterus, regardless of clinical symptoms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women,&#xD;
&#xD;
          -  Pregnant women,&#xD;
&#xD;
          -  Gynaecological cancer,&#xD;
&#xD;
          -  GnRH analog therapy or systemic hormone therapy in the last three months prior to&#xD;
             hysterectomy,&#xD;
&#xD;
          -  Endometriosis,&#xD;
&#xD;
          -  Uterine fibroids&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tina Tellum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital, Ullevål</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marit Lieng, PhD, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital</name>
      <address>
        <city>Oslo</city>
        <zip>0382</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Tina Tellum</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Peristalsis</keyword>
  <keyword>ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Adenomyosis</mesh_term>
    <mesh_term>Dysmenorrhea</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/NCT02197936
org study id: 2014/637c
nct id: NCT02197936
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and
      the role of correct peristalsis is most important for correct sperm transport towards the
      fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time,
      an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and
      may also account for heavy menstrual bleedings and menstrual pain.

      In this study, the uterine peristalsis of women with adenomyosis will be investigated. This
      condition is associated to heavy menstrual bleeding, menstrual pain and infertility.
The peristalsis of the non-pregnant uterus is widely investigated and the role of correct
      peristalsis seems to be most important for correct sperm transport towards the fallopian
      tubes and implantation of the embryo. At the same time, an impaired uterine peristalsis is
      discussed to be the reason for lower pregnancy rates and may account for dysmenorrhea and
      menorrhagia. The connection of impaired peristalsis and various clinical symptoms has been
      shown for patients with e.g. leiomyoma and endometriosis, but not for women with adenomyosis,
      though the concept seems to be widely accepted.

      It has also been repeatedly postulated that impaired peristalsis interferes with implantation
      of the embryo, yet Martinez-Conejero published a trial that showed a higher incidence of
      miscarriage, but no effect on embryo implantation in women undergoing oocyte donation. This
      might either indicate that the postulated effect of peristalsis is wrong or, more likely,
      since this is a study in an IVF setting, that hormonal treatment with gonadotropin-releasing
      hormone (GnRH)-agonist could improve implantation.

      It is possible to monitor peristalsis with transvaginal ultrasound and standard patterns of
      uterine peristalsis are defined by Jiland already in 1996.

      Findings resulting from the investigations in this study may help to determine the role and
      extent of impaired peristalsis in women with adenomyosis and possibly give new clues on
      potential treatments, as well as fill a gap in today's knowledge.
observational model: Case-Control
time perspective: Prospective
measure: Frequency of peristaltic waves in Hz
time frame: five minutes
description: Frequencies of peristalsis in patients with and without adenomyosis will be compared.
measure: Altitude of peristaltic waves in mm
time frame: five minutes
description: The altitude of the peristaltic waves in patients with and without adenomyosis will so be compared.
measure: direction of uterine peristalsis: antegrade, retrograde
time frame: 5 minutes, at time of ovulation
description: Dynamic motility characterization of the uterine peristalsis in women with adenomyosis.
arm group label: Peristalsis adenomyosis
description: with adenomyosis
arm group label: Peristalsis control
description: No adenomyosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tina Tellum, MD
role: Principal Investigator
affiliation: Oslo University Hospital, Ullevål
last name: Marit Lieng, PhD, MD
role: Study Chair
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Tina Tellum
investigator title: Medical Doctor
mesh term: Infertility
mesh term: Adenomyosis
mesh term: Dysmenorrhea