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/NCT06021886</url>
    </required_header>
    <id_info>
      <org_study_id>REC/2023/P38</org_study_id>
      <nct_id>NCT06021886</nct_id>
    </id_info>
    <brief_title>CS Scar Impact on ART Outcomes</brief_title>
    <official_title>CS Scar Impact on ART Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HealthPlus Fertility Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>HealthPlus Fertility Center</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>
        CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the&#xD;
        presence of caesarean section scar with or without defect in different ways&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the&#xD;
        presence of caesarean section scar with or without defect in different ways; increase&#xD;
        difficulty of embryo transfer, presence intrauterine fluid at the time of transfer can affect&#xD;
        the chances of embryo implantation and increase the rate of spontaneous miscarriages To&#xD;
        compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid&#xD;
        embryos in patients without caesarean section, and who had caesarean section (with or without&#xD;
        a NICHE) after euploid embryo transfer. Does CS scar and CS scar defect affect IVF outcome?&#xD;
        All women who underwent an embryo transfer with a Euploid embryo between 2015 and 2022, who&#xD;
        meet the inclusion criteria will be included in the study.&#xD;
  &#xD;
          -  Inclusion Criteria: Age 25-40 years old. Euploid embryo transfer. Medically free BMI&#xD;
             less tha 30 kg/m2 Hormone therapy preparation for FET.&#xD;
  &#xD;
          -  Exclusion criteria Previous uterine scar other than cesarean section. Congenital uterine&#xD;
             abnormalities Presence of intrauterine lesions e.g., polyp, fibroid, Endometriosis or&#xD;
             adenomyosis Hydrosalpinx, Chronic endometritis&#xD;
  &#xD;
          -  Primary outcome: Clinical pregnancy rate, defined as a pregnancy with a detectable heart&#xD;
             rate at 7 weeks of gestation or beyond.&#xD;
  &#xD;
          -  Secondary outcomes : Early pregnancy complications Ectopic pregnancy or Miscarriage.&#xD;
             Caesarean section scar dehiscence or&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>CS scar impact on ART outcomes, Retrospective Cohort Study</measure>
      <time_frame>2015 to 2022,</time_frame>
      <description>Clinical pregnancy rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ART outcomes</measure>
      <time_frame>2015 to 2022,</time_frame>
      <description>Early pregnancy complications:&#xD;
  Ectopic pregnancy or Miscarriage.&#xD;
  Caesarean section scar dehiscence or rupture.&#xD;
  Presence of intrauterine fluid accumulation at the time of ET.&#xD;
  Endometrial thickness at the time of ET.&#xD;
  Live birth.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">510</enrollment>
    <condition>Fertility Issues</condition>
    <arm_group>
      <arm_group_label>patient without scar</arm_group_label>
      <description>history of euploid embryo transfer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>patient with cs scar no Niche</arm_group_label>
      <description>history of euploid embryo transfer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>patient with cs scar with niche</arm_group_label>
      <description>history of euploid embryo transfer</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          All women who underwent an embryo transfer with a Euploid embryo between 2005 and 2022, who&#xD;
          meet the inclusion criteria will be included in the study. To compare the success rates and&#xD;
          outcomes of pregnancies of frozen embryo transfer for euploid embryos in patients without&#xD;
          caesarean section, and who had caesarean section (with or without a NICHE) after euploid&#xD;
          embryo transfer.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 25-40 years old.&#xD;
  &#xD;
          Euploid embryo transfer.&#xD;
  &#xD;
          Medically free&#xD;
  &#xD;
          BMI less tha 30 kg/m2&#xD;
  &#xD;
          Hormone therapy preparation for FET.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Exclusion criteria&#xD;
  &#xD;
          Previous uterine scar other than cesarean section.&#xD;
  &#xD;
          Congenital uterine abnormalities&#xD;
  &#xD;
          Presence of intrauterine lesions e.g., polyp, fibroid,&#xD;
  &#xD;
          Endometriosis or adenomyosis&#xD;
  &#xD;
          Hydrosalpinx, Chronic endometritis&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>HealthPlus fertility Centre</name>
        <address>
          <city>Abu Dhabi</city>
          <country>United Arab Emirates</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>HealthPLus Dr Ahmed Al Bohoty, consultant</last_name>
        <phone>050406730</phone>
        <email>ahmed.bohoty@hplus.ae</email>
      </contact>
      <contact_backup>
        <last_name>Waleed Sayed, consultant</last_name>
        <phone>0506638001</phone>
        <email>walid.sayed@hplus.ae</email>
      </contact_backup>
      <investigator>
        <last_name>Amani Kanan, specialist</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Arab Emirates</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>HealthPlus Fertility Center</investigator_affiliation>
      <investigator_full_name>Ahmed Elsayed Hassan Hamed Elbohoty</investigator_full_name>
      <investigator_title>Reproductive medicine consultant</investigator_title>
    </responsible_party>
    <keyword>CS Scar Impact on ART Outcomes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
    </condition_browse>
    <!-- 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/NCT06021886
  org study id: REC/2023/P38
  nct id: NCT06021886
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the
        presence of caesarean section scar with or without defect in different ways
  CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the
        presence of caesarean section scar with or without defect in different ways; increase
        difficulty of embryo transfer, presence intrauterine fluid at the time of transfer can affect
        the chances of embryo implantation and increase the rate of spontaneous miscarriages To
        compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid
        embryos in patients without caesarean section, and who had caesarean section (with or without
        a NICHE) after euploid embryo transfer. Does CS scar and CS scar defect affect IVF outcome?
        All women who underwent an embryo transfer with a Euploid embryo between 2015 and 2022, who
        meet the inclusion criteria will be included in the study.
  
          -  Inclusion Criteria: Age 25-40 years old. Euploid embryo transfer. Medically free BMI
             less tha 30 kg/m2 Hormone therapy preparation for FET.
  
          -  Exclusion criteria Previous uterine scar other than cesarean section. Congenital uterine
             abnormalities Presence of intrauterine lesions e.g., polyp, fibroid, Endometriosis or
             adenomyosis Hydrosalpinx, Chronic endometritis
  
          -  Primary outcome: Clinical pregnancy rate, defined as a pregnancy with a detectable heart
             rate at 7 weeks of gestation or beyond.
  
          -  Secondary outcomes : Early pregnancy complications Ectopic pregnancy or Miscarriage.
             Caesarean section scar dehiscence or
  observational model: Cohort
  time perspective: Retrospective
  measure: CS scar impact on ART outcomes, Retrospective Cohort Study
  time frame: 2015 to 2022,
  description: Clinical pregnancy rate
  measure: ART outcomes
  time frame: 2015 to 2022,
  description: Early pregnancy complications:
  Ectopic pregnancy or Miscarriage.
  Caesarean section scar dehiscence or rupture.
  Presence of intrauterine fluid accumulation at the time of ET.
  Endometrial thickness at the time of ET.
  Live birth.
  arm group label: patient without scar
  description: history of euploid embryo transfer
  arm group label: patient with cs scar no Niche
  description: history of euploid embryo transfer
  arm group label: patient with cs scar with niche
  description: history of euploid embryo transfer
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 25 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United Arab Emirates
  responsible party type: Principal Investigator
  investigator affiliation: HealthPlus Fertility Center
  investigator full name: Ahmed Elsayed Hassan Hamed Elbohoty
  investigator title: Reproductive medicine consultant
  mesh term: Infertility