<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/NCT03784404</url>
  </required_header>
  <id_info>
    <org_study_id>45</org_study_id>
    <nct_id>NCT03784404</nct_id>
  </id_info>
  <brief_title>Trans-vaginal Aspiration of Small Ovarian Endometrioma. Comparison of Two Different Techniques Before ICSI</brief_title>
  <official_title>Trans-vaginal Aspiration With or Without Injection of Surgicel for Treatment of Small Ovarian Endometrioma Before ICSI Cycles. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized&#xD;
      to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of&#xD;
      small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that&#xD;
      preceded the induction cycle of ICSI&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized&#xD;
      to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of&#xD;
      small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that&#xD;
      preceded the induction cycle of ICSI.&#xD;
&#xD;
      Transvaginal aspiration will be done under ultrasonographic guidance with spinal needle&#xD;
      insertion inside the cyst cavity followed by aspiration of the chocolate material from the&#xD;
      cyst &amp; then irrigation of the cyst cavity with normal saline solution till complete&#xD;
      elimination of the chocolate material. The needle will be withdrawn in women in non-Surgicel&#xD;
      group while injection of small pieces of surgicel inside the cyst cavity will be done for&#xD;
      women in the surgicel group followed by withdrawal of the needle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>14 days after embryo transfer</time_frame>
    <description>documentation of intrauterine fetal sac using transvaginal ultrasound</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ovarian Endometrioma</condition>
  <arm_group>
    <arm_group_label>Non surgicel group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgicel group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transvaginal aspiration</intervention_name>
    <description>under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material</description>
    <arm_group_label>Non surgicel group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transvaginal aspiration and surgicel injection</intervention_name>
    <description>under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity</description>
    <arm_group_label>Surgicel group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intracytoplasmic sperm injection</intervention_name>
    <description>Candidates for the standard long protocol received triptorelin 0.1 mg Subcutanous daily starting from day 21 of the previous cycle. On the second day of the stimulation cycle, pituitary downregulation was confirmed. Controlled ovarian stimulation was then started on day 3 using Human Menopausal Gonadotropin (Menogon; Ferring). The dose of gonadotropin was individualized. The patients were monitored with serial ultrasound and serum E2. When at least 3 follicles reached 18 mm, ovulation was triggered using Human Chorionic Gonadotropin 10000 IU (Epifasi 10000 IU; Eipico, Tenth of Ramadan, Egypt) IM and ovum pickup was performed 35 hours later.&#xD;
All cases received luteal support in the form of progesterone 400 mg twice daily. Embryo transfer was done on day 3 or 5 using Labotect semi-rigid catheter (Labotect GmbH, Kassel area, Germany) under abdominal ultrasound guidance.</description>
    <arm_group_label>Non surgicel group</arm_group_label>
    <arm_group_label>Surgicel group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subfertile women indicated for ICSI&#xD;
&#xD;
          -  having a single endometrioma of less than 5 cm with typical sonographic criteria; a&#xD;
             cyst with 1 to 4 locules and ground glass appearance of the cyst fluid with no&#xD;
             papillary projections and no or minimal vascularization of the cyst capsule. Since&#xD;
             endometriotic cysts measuringmore than 1 cm are readily diagnosed by ultrasound,25 we&#xD;
             chose a diameter of 2 cm as the lower limit to declare a cyst as endometrioma.&#xD;
&#xD;
          -  All cases had a normal uterine cavity demonstrated by ultrasonography and&#xD;
             hysteroscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral or multiple endometriomas, lesions of more than 5 cm or showing atypical&#xD;
             sonographic features presence of uterine pathology (eg, polyp or fibroid)&#xD;
&#xD;
          -  follicle-stimulating hormone (FSH) of more than 10,&#xD;
&#xD;
          -  body mass index of more than 30, age more than 40 years,&#xD;
&#xD;
          -  cases who received previous GnRH therapy for treatment of endometriosis within 12&#xD;
             months of the study&#xD;
&#xD;
          -  patients who received oral contraceptive pills or any form of hormones for the&#xD;
             previous 3 months,&#xD;
&#xD;
          -  patients with previous surgical resection of endometrioma&#xD;
&#xD;
          -  severe male factor.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Maged, MD</last_name>
    <phone>+201005227404</phone>
    <email>prof.ahmedmaged@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>fadel shaltout, MD</last_name>
    <phone>+201006023073</phone>
    <email>dr.shaltout@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03784404
org study id: 45
nct id: NCT03784404
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized
      to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of
      small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that
      preceded the induction cycle of ICSI
women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized
      to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of
      small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that
      preceded the induction cycle of ICSI.

      Transvaginal aspiration will be done under ultrasonographic guidance with spinal needle
      insertion inside the cyst cavity followed by aspiration of the chocolate material from the
      cyst & then irrigation of the cyst cavity with normal saline solution till complete
      elimination of the chocolate material. The needle will be withdrawn in women in non-Surgicel
      group while injection of small pieces of surgicel inside the cyst cavity will be done for
      women in the surgicel group followed by withdrawal of the needle.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: clinical pregnancy rate
time frame: 14 days after embryo transfer
description: documentation of intrauterine fetal sac using transvaginal ultrasound
arm group label: Non surgicel group
arm group type: Active Comparator
description: under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material
arm group label: Surgicel group
arm group type: Active Comparator
description: under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity
intervention type: Procedure
intervention name: Transvaginal aspiration
description: under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material
arm group label: Non surgicel group
intervention type: Procedure
intervention name: transvaginal aspiration and surgicel injection
description: under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity
arm group label: Surgicel group
intervention type: Drug
intervention name: Intracytoplasmic sperm injection
description: Candidates for the standard long protocol received triptorelin 0.1 mg Subcutanous daily starting from day 21 of the previous cycle. On the second day of the stimulation cycle, pituitary downregulation was confirmed. Controlled ovarian stimulation was then started on day 3 using Human Menopausal Gonadotropin (Menogon; Ferring). The dose of gonadotropin was individualized. The patients were monitored with serial ultrasound and serum E2. When at least 3 follicles reached 18 mm, ovulation was triggered using Human Chorionic Gonadotropin 10000 IU (Epifasi 10000 IU; Eipico, Tenth of Ramadan, Egypt) IM and ovum pickup was performed 35 hours later.
All cases received luteal support in the form of progesterone 400 mg twice daily. Embryo transfer was done on day 3 or 5 using Labotect semi-rigid catheter (Labotect GmbH, Kassel area, Germany) under abdominal ultrasound guidance.
arm group label: Non surgicel group
arm group label: Surgicel group
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: Professor
last name: Ahmed Maged, MD
phone: +201005227404
email: prof.ahmedmaged@gmail.com
last name: fadel shaltout, MD
phone: +201006023073
email: dr.shaltout@gmail.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: Principal investigator
mesh term: Endometriosis
sharing ipd: Undecided