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/NCT05987995</url>
    </required_header>
    <id_info>
      <org_study_id>0105711</org_study_id>
      <nct_id>NCT05987995</nct_id>
    </id_info>
    <brief_title>Is it Safe to do Endometrial Injury in the Same ICSI Cycle: A Randomized Controlled Trial</brief_title>
    <official_title>Is it Safe to do Endometrial Injury in the Same ICSI Cycle: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria 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>
        Endometrial injury is one of the interventions suggested to improve the endometrial&#xD;
        receptivity by enhancing the decidualization process, and so increasing the pregnancy rate&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In assisted reproductive techniques , specially ICSI, several approaches have been put&#xD;
        forward to improve the endometrium, including endometrial injection of granulocyte&#xD;
        colony-stimulating factor or platelet-rich plasma. Endometrial injury is one of the&#xD;
        interventions suggested to improve the endometrial receptivity.&#xD;
  &#xD;
        Endometrial injury, also known as endometrial scratching, is the intentional damage of the&#xD;
        endometrium, usually using a pipelle, aiming at increasing the implantation rate. The exact&#xD;
        mechanism of action is still vague ,many hypotheses have been advocated, including enhanced&#xD;
        decidualization, which is stimulated by the local injury. Moreover, endometrial injury&#xD;
        stimulates an inflammatory response, which in turn adjusts gene expression.&#xD;
  &#xD;
        The value of endometrial injury is a controversial issue, there is no agreement on the exact&#xD;
        time to perform endometrial scratching, so in the current study, we investigated the safety&#xD;
        and efficacy of performing endometrial injury in the follicular phase of the same ICSI cycle.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 11, 2022</start_date>
    <completion_date type="Actual">January 20, 2023</completion_date>
    <primary_completion_date type="Actual">January 20, 2023</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pregnancy rate</measure>
      <time_frame>15 days after HCG administration</time_frame>
      <description>Quantitative beta HCG test is done</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Infertility</condition>
    <arm_group>
      <arm_group_label>Endometrial injury group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Endometrial injury was done on day 3-5 of stimulation, just after the cessation of menstruation. After the insertion of a vaginal speculum, the cervix was cleaned using a sterile saline solution. A pipelle endometrial sampler was introduced gently into the uterine cavity. The inner piston of the catheter was withdrawn to create suction, and injury (scratching) of the endometrium was done by moving the pipelle catheter up and down within the uterine cavity. The obtained tissues were seen in a transparent tube. If no tissues were seen in the tube, the procedure was repeated.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>no thing is done for this group</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endometrial injury</intervention_name>
      <description>A pipelle endometrial sampler was introduced gently into the uterine cavity. The inner piston of the catheter was withdrawn to create suction, and injury (scratching) of the endometrium was done by moving the pipelle catheter up and down within the uterine cavity</description>
      <arm_group_label>Endometrial injury group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;40 year.&#xD;
  &#xD;
            -  BMI 20-35 kg/m2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;40 year&#xD;
  &#xD;
            -  BMI &gt; 35&#xD;
  &#xD;
            -  Uterine cavity abnormalities&#xD;
  &#xD;
            -  poor quality embryos&#xD;
  &#xD;
            -  Poor responders&#xD;
  &#xD;
            -  Diagnosed sever endometriosis&#xD;
  &#xD;
            -  Sever male factor&#xD;
  &#xD;
            -  Declined to participate&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>infertile females that seeking pregnancy</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tamer</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2022</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Endometrial injury</keyword>
    <keyword>ICSI</keyword>
    <keyword>infertility</keyword>
    <keyword>pregnancy rate</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/NCT05987995
  org study id: 0105711
  nct id: NCT05987995
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Endometrial injury is one of the interventions suggested to improve the endometrial
        receptivity by enhancing the decidualization process, and so increasing the pregnancy rate
  In assisted reproductive techniques , specially ICSI, several approaches have been put
        forward to improve the endometrium, including endometrial injection of granulocyte
        colony-stimulating factor or platelet-rich plasma. Endometrial injury is one of the
        interventions suggested to improve the endometrial receptivity.
  
        Endometrial injury, also known as endometrial scratching, is the intentional damage of the
        endometrium, usually using a pipelle, aiming at increasing the implantation rate. The exact
        mechanism of action is still vague ,many hypotheses have been advocated, including enhanced
        decidualization, which is stimulated by the local injury. Moreover, endometrial injury
        stimulates an inflammatory response, which in turn adjusts gene expression.
  
        The value of endometrial injury is a controversial issue, there is no agreement on the exact
        time to perform endometrial scratching, so in the current study, we investigated the safety
        and efficacy of performing endometrial injury in the follicular phase of the same ICSI cycle.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: pregnancy rate
  time frame: 15 days after HCG administration
  description: Quantitative beta HCG test is done
  arm group label: Endometrial injury group
  arm group type: Experimental
  description: Endometrial injury was done on day 3-5 of stimulation, just after the cessation of menstruation. After the insertion of a vaginal speculum, the cervix was cleaned using a sterile saline solution. A pipelle endometrial sampler was introduced gently into the uterine cavity. The inner piston of the catheter was withdrawn to create suction, and injury (scratching) of the endometrium was done by moving the pipelle catheter up and down within the uterine cavity. The obtained tissues were seen in a transparent tube. If no tissues were seen in the tube, the procedure was repeated.
  arm group label: Control group
  arm group type: No Intervention
  description: no thing is done for this group
  intervention type: Procedure
  intervention name: Endometrial injury
  description: A pipelle endometrial sampler was introduced gently into the uterine cavity. The inner piston of the catheter was withdrawn to create suction, and injury (scratching) of the endometrium was done by moving the pipelle catheter up and down within the uterine cavity
  arm group label: Endometrial injury group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: infertile females that seeking pregnancy
  minimum age: N/A
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Infertility