xml: <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/NCT06036459</url>
    </required_header>
    <id_info>
      <org_study_id>Uterine Peristalsis in IVF</org_study_id>
      <nct_id>NCT06036459</nct_id>
    </id_info>
    <brief_title>Uterine Peristalsis in IVF</brief_title>
    <official_title>Effect of Uterine Peristalsis at the Time of Embryo Transfer on the Outcomes of IVF Cycles: a Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        An observational prospective cohort study to evaluate the effect of uterine peristalsis at&#xD;
        the time of embryo transfer on IVF clinical outcomes performed in Women's Health hospital,&#xD;
        Assiut University, Egypt.&#xD;
  &#xD;
        Women performing fresh or frozen embryo transfer who do not have any uterine abnormalities&#xD;
        will be included in the study&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical pregnancy</measure>
      <time_frame>2 weeks after a positive pregnancy test</time_frame>
      <description>The presence of intrauterine gestational sac and fetal pole with positive cardiac pulsation by transvaginal ultrasound</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Biochemical pregnancy</measure>
      <time_frame>2 weeks after embryo transfer</time_frame>
      <description>a positive serum human chorionic gonadotropin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Miscarriage</measure>
      <time_frame>From 6 weeks of gestation until 28 weeks of gestation</time_frame>
      <description>Pregnancy loss either loss of cardiac pulsation by ultrasound, or spontaneous loss of pregnancy vaginally</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ectopic pregnancy</measure>
      <time_frame>the site of the gestational sac will be assessed 2 weeks after embryo transfer</time_frame>
      <description>Pregnancy outside the uterine cavity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ongoing pregnancy</measure>
      <time_frame>After 12 weeks of gestation until delivery</time_frame>
      <description>The presence of a viable pregnancy after 12 weeks of gestation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Live birth</measure>
      <time_frame>From 28 weeks of gestation until delivery</time_frame>
      <description>Delivery of a living foetus after the age of viability</description>
    </secondary_outcome>
    <enrollment type="Anticipated">117</enrollment>
    <condition>Infertility, Female</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>uterine peristalsis</intervention_name>
      <description>Transabdominal us followed by Transvaginal ultrasonography scans (Sono Ace R5 ) of uterine peristalsis will performed on the day of embryo transfer while the patient lying relaxed in lithotomy position. The probe will be introduced into the vagina as gently as possible to avoid stimulating the cervix. After scanning the mid-sagittal plane of the uterus, the probe will be fixed as steady as possible while a 3 min video of uterine peristalsis will be recorded simultaneously. The records will be analyzed at 4X regular speed using a Video player application by two independent experienced observers. The uterine peristaltic wave frequency will be the mean of the results from each observer.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women undergoing IVF&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Women undergoing embryo transfer during IVF cycles.&#xD;
  &#xD;
                 -  Age: between 20 and 40 years.&#xD;
  &#xD;
                 -  Have at least 1 good quality embryo at the time of transfer&#xD;
  &#xD;
                 -  Fresh or frozen-thawed cycles.&#xD;
  &#xD;
                 -  Any stimulation protocol in fresh cycles, or any endometrial preparation protocol&#xD;
                    for frozen-thawed cycles&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Women refusing to participate in clinical research.&#xD;
  &#xD;
                 -  Any uncorrected uterine abnormality, such as septum, myoma, adenomyosis, or polyp&#xD;
  &#xD;
                 -  Hydrosalpinx without prior disconnection or excision&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Karim Abdallah, MD</last_name>
      <phone>+201270595485</phone>
      <email>karimsayed88@aun.edu.eg</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Karim Abdallah</investigator_full_name>
      <investigator_title>Principle 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>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036459
  org study id: Uterine Peristalsis in IVF
  nct id: NCT06036459
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  An observational prospective cohort study to evaluate the effect of uterine peristalsis at
        the time of embryo transfer on IVF clinical outcomes performed in Women's Health hospital,
        Assiut University, Egypt.
  
        Women performing fresh or frozen embryo transfer who do not have any uterine abnormalities
        will be included in the study
  observational model: Cohort
  time perspective: Prospective
  measure: Clinical pregnancy
  time frame: 2 weeks after a positive pregnancy test
  description: The presence of intrauterine gestational sac and fetal pole with positive cardiac pulsation by transvaginal ultrasound
  measure: Biochemical pregnancy
  time frame: 2 weeks after embryo transfer
  description: a positive serum human chorionic gonadotropin
  measure: Miscarriage
  time frame: From 6 weeks of gestation until 28 weeks of gestation
  description: Pregnancy loss either loss of cardiac pulsation by ultrasound, or spontaneous loss of pregnancy vaginally
  measure: Ectopic pregnancy
  time frame: the site of the gestational sac will be assessed 2 weeks after embryo transfer
  description: Pregnancy outside the uterine cavity
  measure: Ongoing pregnancy
  time frame: After 12 weeks of gestation until delivery
  description: The presence of a viable pregnancy after 12 weeks of gestation
  measure: Live birth
  time frame: From 28 weeks of gestation until delivery
  description: Delivery of a living foetus after the age of viability
  intervention type: Other
  intervention name: uterine peristalsis
  description: Transabdominal us followed by Transvaginal ultrasonography scans (Sono Ace R5 ) of uterine peristalsis will performed on the day of embryo transfer while the patient lying relaxed in lithotomy position. The probe will be introduced into the vagina as gently as possible to avoid stimulating the cervix. After scanning the mid-sagittal plane of the uterus, the probe will be fixed as steady as possible while a 3 min video of uterine peristalsis will be recorded simultaneously. The records will be analyzed at 4X regular speed using a Video player application by two independent experienced observers. The uterine peristaltic wave frequency will be the mean of the results from each observer.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Karim Abdallah, MD
  phone: +201270595485
  email: karimsayed88@aun.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Karim Abdallah
  investigator title: Principle investigator
  mesh term: Infertility
  mesh term: Infertility, Female
  sharing ipd: Undecided