<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/NCT03788720</url>
  </required_header>
  <id_info>
    <org_study_id>SOAVE-1</org_study_id>
    <nct_id>NCT03788720</nct_id>
  </id_info>
  <brief_title>Suture of the Ovary After Enucleation of Ovarian Endometrioma</brief_title>
  <acronym>SOAVE-1</acronym>
  <official_title>Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi dell'Insubria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi dell'Insubria</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>
      Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of&#xD;
      ectopic endometrial-like tissue outside the uterine cavity.&#xD;
&#xD;
      According to the most updated guidelines of the European Society of Human Reproduction and&#xD;
      Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed&#xD;
      directly to Assisted Reproduction Technology (ART); conversely, for infertile women with&#xD;
      endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in&#xD;
      order to improve reproductive outcomes (both spontaneous and ART pregnancy rate).&#xD;
&#xD;
      To date, literature data do not allow to draw a firm conclusion about the best strategy to&#xD;
      reduce ovarian damage during enucleation of ovarian endometriomas: in particular,&#xD;
      investigators still lack robust evidence in order to choose between suturing the ovary or not&#xD;
      after the enucleation.&#xD;
&#xD;
      In this scenario, the aim of our the study will be to compare functional outcomes of the&#xD;
      ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic&#xD;
      enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation&#xD;
      of endometriomas without subsequent suture of the ovarian cortex.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">May 2023</start_date>
  <completion_date type="Anticipated">May 2027</completion_date>
  <primary_completion_date type="Anticipated">May 2025</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>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Surgeons who perform the surgery will be not masked for the treatment allocation.&#xD;
Evaluators (sonographers, data analyzers) will be blind for the treatment allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Antral Follicle Count (AFC)</measure>
    <time_frame>Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery</time_frame>
    <description>AFC will be evaluated on day 3 of the cycle by a transvaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated. Further the number of small antral follicles in both the ovaries is measured. These follicles could vary in size from 2-10 mm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery</measure>
    <time_frame>Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery</time_frame>
    <description>Evaluation of the pulsatility index (PI; minimum: 0; maximum: 7; higher values represent a better outcome) of the ovarian artery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resistive index, evaluated by Doppler flowmetry, of the ovarian artery</measure>
    <time_frame>Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery</time_frame>
    <description>Evaluation of the resistive index (RI minimum: 0; maximum: 3; higher values represent a worse outcome) of the ovarian artery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ovarian volume</measure>
    <time_frame>Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery</time_frame>
    <description>Evaluation of the ovarian volume calculated using the prolate ellipsoid formula (length x height x width x 0.523)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Endometrioma</condition>
  <arm_group>
    <arm_group_label>Suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No suture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suture of the ovarian cortex</intervention_name>
    <description>Suture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots).</description>
    <arm_group_label>Suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No suture of the ovarian cortex</intervention_name>
    <description>Laparoscopic enucleation of endometriomas without suture of the ovarian cortex</description>
    <arm_group_label>No suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with&#xD;
             maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping&#xD;
             technique;&#xD;
&#xD;
          -  Normal AFC at the enrollment (baseline).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other disease;&#xD;
&#xD;
          -  Bilateral endometriomas;&#xD;
&#xD;
          -  Deep infiltrating endometriosis;&#xD;
&#xD;
          -  No previous pelvic surgery (even not gynecological);&#xD;
&#xD;
          -  Any other pharmacologic and non pharmacologic treatment in the previous 3 months&#xD;
             (wash-out period);&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Simone Laganà, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi dell'Insubria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fabio Ghezzi, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Università degli Studi dell'Insubria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jvan Casarin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi dell'Insubria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Simone Garzon</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi dell'Insubria</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antonio Simone Laganà, M.D.</last_name>
    <phone>+393296279579</phone>
    <email>antoniosimone.lagana@asst-settelaghi.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>&quot;Filippo Del Ponte&quot; Hospital</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Antonio Simone Laganà, M.D.</last_name>
      <phone>+393296279579</phone>
      <email>antoniosimone.lagana@asst-settelaghi.it</email>
    </contact>
    <investigator>
      <last_name>Davide Sturla, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giulia Bordi, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi dell'Insubria</investigator_affiliation>
    <investigator_full_name>Antonio Simone Laganà</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Endometrioma</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Suture</keyword>
  <keyword>Ovary</keyword>
  <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/NCT03788720
org study id: SOAVE-1
nct id: NCT03788720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of
      ectopic endometrial-like tissue outside the uterine cavity.

      According to the most updated guidelines of the European Society of Human Reproduction and
      Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed
      directly to Assisted Reproduction Technology (ART); conversely, for infertile women with
      endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in
      order to improve reproductive outcomes (both spontaneous and ART pregnancy rate).

      To date, literature data do not allow to draw a firm conclusion about the best strategy to
      reduce ovarian damage during enucleation of ovarian endometriomas: in particular,
      investigators still lack robust evidence in order to choose between suturing the ovary or not
      after the enucleation.

      In this scenario, the aim of our the study will be to compare functional outcomes of the
      ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic
      enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation
      of endometriomas without subsequent suture of the ovarian cortex.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Surgeons who perform the surgery will be not masked for the treatment allocation.
Evaluators (sonographers, data analyzers) will be blind for the treatment allocation.
measure: Antral Follicle Count (AFC)
time frame: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
description: AFC will be evaluated on day 3 of the cycle by a transvaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated. Further the number of small antral follicles in both the ovaries is measured. These follicles could vary in size from 2-10 mm.
measure: Pulsatility index, evaluated by Doppler flowmetry, of the ovarian artery
time frame: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
description: Evaluation of the pulsatility index (PI; minimum: 0; maximum: 7; higher values represent a better outcome) of the ovarian artery.
measure: Resistive index, evaluated by Doppler flowmetry, of the ovarian artery
time frame: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
description: Evaluation of the resistive index (RI minimum: 0; maximum: 3; higher values represent a worse outcome) of the ovarian artery.
measure: Ovarian volume
time frame: Change from day 3 of the menstrual cycle prior to the elective laparoscopic surgery to day 3 of the menstrual cycle after to the elective laparoscopic surgery
description: Evaluation of the ovarian volume calculated using the prolate ellipsoid formula (length x height x width x 0.523)
arm group label: Suture
arm group type: Experimental
description: Women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas.
arm group label: No suture
arm group type: Sham Comparator
description: Women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.
intervention type: Procedure
intervention name: Suture of the ovarian cortex
description: Suture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots).
arm group label: Suture
intervention type: Procedure
intervention name: No suture of the ovarian cortex
description: Laparoscopic enucleation of endometriomas without suture of the ovarian cortex
arm group label: No suture
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Antonio Simone Laganà, M.D.
role: Principal Investigator
affiliation: Università degli Studi dell'Insubria
last name: Fabio Ghezzi, M.D.
role: Study Director
affiliation: Università degli Studi dell'Insubria
last name: Jvan Casarin, M.D.
role: Principal Investigator
affiliation: Università degli Studi dell'Insubria
last name: Simone Garzon
role: Principal Investigator
affiliation: Università degli Studi dell'Insubria
last name: Antonio Simone Laganà, M.D.
phone: +393296279579
email: antoniosimone.lagana@asst-settelaghi.it
facility: 
contact: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi dell'Insubria
investigator full name: Antonio Simone Laganà
investigator title: Principal Investigator
mesh term: Endometriosis
sharing ipd: Undecided