<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/NCT02245750</url>
  </required_header>
  <id_info>
    <org_study_id>Routine Hysterscopy</org_study_id>
    <nct_id>NCT02245750</nct_id>
  </id_info>
  <brief_title>Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the current study the investigators hypothesize that Routine Hysteroscopy prior to&#xD;
      IVF/ICSI cycle increases the clinical pregnancy rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled study involving 300 patients with recurrent implantation failure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>• Clinical pregnancy rate.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>• Live Birth Rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>• Uterine anomalies detected by Hysteroscopy</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Routine Invistigations</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>ICSI with long luteal phase protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hysteroscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hysteroscopy will be done prior to the ICSI cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hysteroscopy</intervention_name>
    <description>hysteroscopy and endometrial injury prior to the IVF/ICSI cycle</description>
    <arm_group_label>Hysteroscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient's age ranged from 20-40 years.&#xD;
&#xD;
          2. Normal appearance of the uterine cavity on hysterosalpingography.&#xD;
&#xD;
          3. Patients prepared for IVF/ICSI cycle.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy,&#xD;
             severe vaginitis or cervicitis, endometrial infection and history of Pelvic&#xD;
             Inflammatory Diseases).&#xD;
&#xD;
          2. Patients with uterine cavity pathology previously known to the examiner.&#xD;
&#xD;
          3. Patients with previous uterine surgery such as myomectomy.&#xD;
&#xD;
          4. Patients with abnormal HSG.&#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_official>
    <last_name>mostafa f gomaa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed M Mohammed, MbbcH</last_name>
    <phone>00201110362860</phone>
    <email>ahmadmarzok85@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mostafa f gomaa, MD</last_name>
    <phone>01226188993</phone>
    <email>mostafafouadg@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ain Shams Maternity hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>mostafa F gomaa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>April 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>mostafa fouad</investigator_full_name>
    <investigator_title>Value of Routine Hysteroscopy prior to IVF/ICSI Cycles: A Randomized Control Trial</investigator_title>
  </responsible_party>
  <keyword>hysteroscopy - recurrent implantation failure</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>


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/NCT02245750
org study id: Routine Hysterscopy
nct id: NCT02245750
lead sponsor: 
has dmc: Yes
In the current study the investigators hypothesize that Routine Hysteroscopy prior to
      IVF/ICSI cycle increases the clinical pregnancy rate.
A randomized controlled study involving 300 patients with recurrent implantation failure
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: • Clinical pregnancy rate.
time frame: 6 months
measure: • Live Birth Rate
time frame: 6 months
measure: • Uterine anomalies detected by Hysteroscopy
time frame: 6 months
arm group label: Routine Invistigations
arm group type: No Intervention
description: ICSI with long luteal phase protocol
arm group label: Hysteroscopy
arm group type: Experimental
description: hysteroscopy will be done prior to the ICSI cycle
intervention type: Device
intervention name: Hysteroscopy
description: hysteroscopy and endometrial injury prior to the IVF/ICSI cycle
arm group label: Hysteroscopy
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: mostafa f gomaa, MD
role: Principal Investigator
affiliation: Ain Shams University
last name: Ahmed M Mohammed, MbbcH
phone: 00201110362860
email: ahmadmarzok85@gmail.com
last name: mostafa f gomaa, MD
phone: 01226188993
email: mostafafouadg@gmail.com
facility: 
status: Recruiting
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: mostafa fouad
investigator title: Value of Routine Hysteroscopy prior to IVF/ICSI Cycles: A Randomized Control Trial
mesh term: Infertility