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/NCT05966558</url>
    </required_header>
    <id_info>
      <org_study_id>9385-22-3-2022</org_study_id>
      <nct_id>NCT05966558</nct_id>
    </id_info>
    <brief_title>Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome</brief_title>
    <official_title>Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zagazig University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zagazig 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>
        the presence of cesarean section niche has adverse effects on success of ART outcome&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A common finding by ultrasound in secondary infertility patients with previous cesarean&#xD;
        sections is the presence of niche, which is formally defined as an indentation of the uterine&#xD;
        myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of&#xD;
        niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain,&#xD;
        dyspareunia, and sub-fertility/infertility.&#xD;
  &#xD;
        It has been reported that a niche can reduce the chances of embryo implantation and may lead&#xD;
        to spontaneous miscarriages if the implantation is close to or in the niche. The presence of&#xD;
        a niche may render the actual embryo transfer procedure technically more difficult, and&#xD;
        clinicians need to be aware of its presence and perform the transfer under ultrasound&#xD;
        guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the&#xD;
        impact of c.s niche and its characteristics on outcome of ART is not clear.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 22, 2020</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.</measure>
      <time_frame>2 years</time_frame>
      <description>cesarean section scar niche will be measured by TVS</description>
    </primary_outcome>
    <enrollment type="Anticipated">266</enrollment>
    <condition>Cesarean Section Niche Impact on ART</condition>
    <eligibility>
      <study_pop>
        <textblock>
          It will be carried out in the department of Obstetrics and Gynecology, Zagazig University&#xD;
          and in a private center.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All women should have the following:&#xD;
  &#xD;
                 -  Aged from 18 - 37 years old.&#xD;
  &#xD;
                 -  Undergoing fresh ICSI cycles.&#xD;
  &#xD;
                 -  A normal uterus with no anomalies or pathologies.&#xD;
  &#xD;
                 -  At least one good-quality embryo/blastocyst available for transfer (3 BB and more&#xD;
                    according to Gardner and Schoolcraft grading system).&#xD;
  &#xD;
                 -  Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without&#xD;
                    touching the fundus, no cervix tenaculum is used and the catheter is clean of&#xD;
                    blood).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Younger than 18 or older than 37 years old.&#xD;
  &#xD;
            -  Congenital uterine abnormality or pathology.&#xD;
  &#xD;
            -  Presence of a hydrosalpinx.&#xD;
  &#xD;
            -  Chronic diseases which are not suitable for pregnancy.&#xD;
  &#xD;
            -  ICSI cycles with fresh or frozen TESE samples.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>37 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>eman elgingy, M.D</last_name>
      <phone>+20 122 749 1143</phone>
      <email>eman_elgindy2013@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>shahenda saleh, M.D</last_name>
      <phone>+20 100 110 9730</phone>
      <email>shahendasaleh20102015ss@gmail.com&quot; &lt;shahendasaleh20102015ss@gmail.com&gt;</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zagazig university</name>
        <address>
          <city>Zagazig</city>
          <zip>44511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>rana nabil, msc</last_name>
        <phone>01005899460</phone>
        <email>rananabil51@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Eman ElGindy, MD, PhD</last_name>
        <phone>01227491143</phone>
        <email>eman_elgindy2013@hotmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>January 20, 2021</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zagazig University</investigator_affiliation>
      <investigator_full_name>Rana Nabil Mohamed Attia</investigator_full_name>
      <investigator_title>Assistant lecturer of obstetrics and gynaecology</investigator_title>
    </responsible_party>
    <keyword>Cesarean Section niche</keyword>
    <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/NCT05966558
  org study id: 9385-22-3-2022
  nct id: NCT05966558
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  the presence of cesarean section niche has adverse effects on success of ART outcome
  A common finding by ultrasound in secondary infertility patients with previous cesarean
        sections is the presence of niche, which is formally defined as an indentation of the uterine
        myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of
        niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain,
        dyspareunia, and sub-fertility/infertility.
  
        It has been reported that a niche can reduce the chances of embryo implantation and may lead
        to spontaneous miscarriages if the implantation is close to or in the niche. The presence of
        a niche may render the actual embryo transfer procedure technically more difficult, and
        clinicians need to be aware of its presence and perform the transfer under ultrasound
        guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the
        impact of c.s niche and its characteristics on outcome of ART is not clear.
  observational model: Cohort
  time perspective: Prospective
  measure: The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.
  time frame: 2 years
  description: cesarean section scar niche will be measured by TVS
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 37 Years
  last name: eman elgingy, M.D
  phone: +20 122 749 1143
  email: eman_elgindy2013@hotmail.com
  last name: shahenda saleh, M.D
  phone: +20 100 110 9730
  email: shahendasaleh20102015ss@gmail.com" <shahendasaleh20102015ss@gmail.com>
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Zagazig University
  investigator full name: Rana Nabil Mohamed Attia
  investigator title: Assistant lecturer of obstetrics and gynaecology
  sharing ipd: Undecided