<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/NCT03227640</url>
  </required_header>
  <id_info>
    <org_study_id>LaserLuM</org_study_id>
    <nct_id>NCT03227640</nct_id>
  </id_info>
  <brief_title>The Impact on Ovarian Reserve of Ovarian Cystectomy Versus Laser Vaporization in the Treatment of Ovarian Endometrioma: a Randomized Clinical Trial</brief_title>
  <acronym>Laser</acronym>
  <official_title>The Impact on Ovarian Reserve of Ovarian Cystectomy Versus Laser Vaporization in the Treatment of Ovarian Endometrioma: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scientific Institute San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scientific Institute San Raffaele</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicentric (two centers: 1:San Raffaele Scientific institute, Milan,&#xD;
      Italy; 2:Jagiellonian University, Collegium Medicum, Cracow, Poland), randomized (1:1)&#xD;
      clinical trial that includes patients undergoing surgery for primary unilateral or bilateral&#xD;
      symptomatic endometriomas.&#xD;
&#xD;
      The aim of the study is to determine whether and to what extent the two surgical procedures&#xD;
      for endometrioma, cystectomy and laser vaporization, affect ovarian reserve. Recently,&#xD;
      cystectomy has been questioned as an ideal surgical approach because it may involve excessive&#xD;
      removal of ovarian tissue and the loss of follicles; laser vaporization has been proposed as&#xD;
      a promising method to preserve ovarian function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Excisional surgery is the recommended treatment for ovarian endometrioma because of higher&#xD;
      pregnancy rate and lower recurrence rate compared with ablative techniques. From the&#xD;
      standpoint of ovarian reserve, the efficiency of cystectomy remains a topic of considerable&#xD;
      debate: in recent years, cystectomy has been questioned as an ideal surgical approach for&#xD;
      endometriomas because it is associated with excessive removal of ovarian tissue and loss of&#xD;
      ovarian follicles with subsequent reduction of ovarian reserve. According to a recent report,&#xD;
      absence of follicular growth was observed in 13% of operated ovaries, although this event&#xD;
      never occurred in the contralateral gonad.&#xD;
&#xD;
      In San Raffaele Scientific Institute, fear of ovarian failure after cystectomy resulted in&#xD;
      the introduction of an ablative technique involving CO2 laser technology, which posses the&#xD;
      ability to deliver energy with little thermal spread. More than 80 patients were treated with&#xD;
      CO2 laser at this Institution during three-year experience. This surgical procedure was&#xD;
      inspired by the one employed by Jacques Donnez for more than 20 years, in which CO2 laser is&#xD;
      used to ablate endometriomas' inner wall, after 3-months GnRHa therapy. Laser vaporization,&#xD;
      according to the ''three-step procedure&quot;, has also been proposed as the best method to&#xD;
      preserve ovarian function; moreover, reassuring data on the rate of long-term recurrence&#xD;
      after laser vaporization have recently been published.&#xD;
&#xD;
      However, no data are available about the single use of CO2 laser fiber vaporization (without&#xD;
      GnRHa therapy) with respect to the ovarian reserve.&#xD;
&#xD;
      Since 2015, the investigators have continuously evaluated the benefits of CO2 laser&#xD;
      vaporization through a clinical trial assessing the postoperative changes in ovarian reserve&#xD;
      as indicated by antral follicle count (AFC) and anti-mullerian hormone (AMH); the results of&#xD;
      this pilot study support the positive effects of CO2 laser on ovarian reserve as demonstrated&#xD;
      by higher AFC and no change in AMH at 3-month follow-up. In order to provide more conclusive&#xD;
      data about the potential advantage of CO2 laser ablation with respect to ovarian cystectomy&#xD;
      in terms of fertility outcomes a prospective randomized trial has been planned; the aim of&#xD;
      this prospective randomized study is to determine whether and to what extent the two surgical&#xD;
      procedures for ovarian endometrioma (cystectomy versus C02 laser vaporization) affect ovarian&#xD;
      reserve.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">January 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in antral follicle count (AFC)</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>number of follicles with average diameter of 2-10 mm in both ovaries assessed on the second and fifth day of the menstrual cycle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in serum antimullerian hormone (AMH) levels</measure>
    <time_frame>baseline and 3 months</time_frame>
    <description>AMH is assessed on venous blood samples (Beckman-Coulter 2nd-generation; Gen II) obtained on day 2-5 of the menstrual cycle</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Endometrioma</condition>
  <arm_group>
    <arm_group_label>stripping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standardized laparoscopic stripping technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CO2 laser vaporization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>drainage of the cyst content and vaporization of the internal wall with CO2 laser</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>stripping technique</intervention_name>
    <description>The cyst is stripped from the healthy ovary by traction and countertraction; after the removal of the cyst, hemostasis is achieved by selective bipolar coagulation.</description>
    <arm_group_label>stripping</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CO2 laser (AcuPulse Duo, Lumenis)</intervention_name>
    <description>The cyst content is drained and the internal wall is vaporized with CO2 laser beam (AcuPulse Duo, Lumenis, Israel)</description>
    <arm_group_label>CO2 laser vaporization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral or bilateral endometriomas&#xD;
&#xD;
          -  pain and/or infertility associated with endometriomas&#xD;
&#xD;
          -  largest diameter of the endometrioma ≥3 cm and ≤ 8 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intra-operative detection of deep infiltrating endometriosis&#xD;
&#xD;
          -  evidence of adenomyosis at the preoperative ultrasound&#xD;
&#xD;
          -  previous surgical procedures on the ovaries&#xD;
&#xD;
          -  previous unilateral oophorectomy&#xD;
&#xD;
          -  previous salpingectomy or hysterectomy&#xD;
&#xD;
          -  thyroid disease&#xD;
&#xD;
          -  hyperprolactinemia&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  adrenal disorders&#xD;
&#xD;
          -  suspected or proven ovarian malignancy&#xD;
&#xD;
          -  evidence of premature ovarian failure (POF) or premature menopause&#xD;
&#xD;
          -  hormonal treatment within 3 months from baseline ovarian reserve assessment and 3&#xD;
             months after surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimo Candiani, MD Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Raffaele Scientific Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jessica Ottolina, MD</last_name>
    <email>ottolina.jessica@hsr.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>San Raffaele Scientific Institute</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Ottolina, MD</last_name>
      <email>ottolina.jessica@hsr.it</email>
    </contact>
    <investigator>
      <last_name>Laura M Castellano, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jessica Ottolina, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Massimo Candiani, MD Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Jagiellonian University, Collegium Medicum, Cracow, Poland</name>
      <address>
        <city>Cracow</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ewa Posadzka, ND</last_name>
      <email>ewaposs@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Ewa Posadzka, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Jach, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 9, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 20, 2017</last_update_submitted>
  <last_update_submitted_qc>July 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Scientific Institute San Raffaele</investigator_affiliation>
    <investigator_full_name>Massimo Candiani</investigator_full_name>
    <investigator_title>Professor</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/NCT03227640
org study id: LaserLuM
nct id: NCT03227640
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multicentric (two centers: 1:San Raffaele Scientific institute, Milan,
      Italy; 2:Jagiellonian University, Collegium Medicum, Cracow, Poland), randomized (1:1)
      clinical trial that includes patients undergoing surgery for primary unilateral or bilateral
      symptomatic endometriomas.

      The aim of the study is to determine whether and to what extent the two surgical procedures
      for endometrioma, cystectomy and laser vaporization, affect ovarian reserve. Recently,
      cystectomy has been questioned as an ideal surgical approach because it may involve excessive
      removal of ovarian tissue and the loss of follicles; laser vaporization has been proposed as
      a promising method to preserve ovarian function.
Excisional surgery is the recommended treatment for ovarian endometrioma because of higher
      pregnancy rate and lower recurrence rate compared with ablative techniques. From the
      standpoint of ovarian reserve, the efficiency of cystectomy remains a topic of considerable
      debate: in recent years, cystectomy has been questioned as an ideal surgical approach for
      endometriomas because it is associated with excessive removal of ovarian tissue and loss of
      ovarian follicles with subsequent reduction of ovarian reserve. According to a recent report,
      absence of follicular growth was observed in 13% of operated ovaries, although this event
      never occurred in the contralateral gonad.

      In San Raffaele Scientific Institute, fear of ovarian failure after cystectomy resulted in
      the introduction of an ablative technique involving CO2 laser technology, which posses the
      ability to deliver energy with little thermal spread. More than 80 patients were treated with
      CO2 laser at this Institution during three-year experience. This surgical procedure was
      inspired by the one employed by Jacques Donnez for more than 20 years, in which CO2 laser is
      used to ablate endometriomas' inner wall, after 3-months GnRHa therapy. Laser vaporization,
      according to the ''three-step procedure", has also been proposed as the best method to
      preserve ovarian function; moreover, reassuring data on the rate of long-term recurrence
      after laser vaporization have recently been published.

      However, no data are available about the single use of CO2 laser fiber vaporization (without
      GnRHa therapy) with respect to the ovarian reserve.

      Since 2015, the investigators have continuously evaluated the benefits of CO2 laser
      vaporization through a clinical trial assessing the postoperative changes in ovarian reserve
      as indicated by antral follicle count (AFC) and anti-mullerian hormone (AMH); the results of
      this pilot study support the positive effects of CO2 laser on ovarian reserve as demonstrated
      by higher AFC and no change in AMH at 3-month follow-up. In order to provide more conclusive
      data about the potential advantage of CO2 laser ablation with respect to ovarian cystectomy
      in terms of fertility outcomes a prospective randomized trial has been planned; the aim of
      this prospective randomized study is to determine whether and to what extent the two surgical
      procedures for ovarian endometrioma (cystectomy versus C02 laser vaporization) affect ovarian
      reserve.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: changes in antral follicle count (AFC)
time frame: baseline and 3 months
description: number of follicles with average diameter of 2-10 mm in both ovaries assessed on the second and fifth day of the menstrual cycle
measure: changes in serum antimullerian hormone (AMH) levels
time frame: baseline and 3 months
description: AMH is assessed on venous blood samples (Beckman-Coulter 2nd-generation; Gen II) obtained on day 2-5 of the menstrual cycle
arm group label: stripping
arm group type: Active Comparator
description: standardized laparoscopic stripping technique
arm group label: CO2 laser vaporization
arm group type: Experimental
description: drainage of the cyst content and vaporization of the internal wall with CO2 laser
intervention type: Procedure
intervention name: stripping technique
description: The cyst is stripped from the healthy ovary by traction and countertraction; after the removal of the cyst, hemostasis is achieved by selective bipolar coagulation.
arm group label: stripping
intervention type: Device
intervention name: CO2 laser (AcuPulse Duo, Lumenis)
description: The cyst content is drained and the internal wall is vaporized with CO2 laser beam (AcuPulse Duo, Lumenis, Israel)
arm group label: CO2 laser vaporization
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Massimo Candiani, MD Prof
role: Principal Investigator
affiliation: San Raffaele Scientific Institute
last name: Jessica Ottolina, MD
email: ottolina.jessica@hsr.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Italy
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Scientific Institute San Raffaele
investigator full name: Massimo Candiani
investigator title: Professor
mesh term: Endometriosis
sharing ipd: Undecided