<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/NCT03826355</url>
  </required_header>
  <id_info>
    <org_study_id>OR</org_study_id>
    <nct_id>NCT03826355</nct_id>
  </id_info>
  <brief_title>Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy</brief_title>
  <official_title>Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</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 a disease characterized by the presence of endometrial tissue outside the&#xD;
      uterus cavity, causing important chronic pain and sterility in those patients suffering from&#xD;
      it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis,&#xD;
      which can coexist in the same patient, exist: deep infiltrating endometriosis (implants&#xD;
      infiltrate &gt; 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA).&#xD;
      OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured&#xD;
      during resection. Consequently, ovarian reserve decreases, worsening the reproductive&#xD;
      prognosis of patients affected. The main objective of the present study is to compare laser&#xD;
      versus conventional OMA excision according to ovarian reserve in a pairwise-data study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">December 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>
    <intervention_model_description>Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The ultrasonographer will be blinded to the procedure performed in each ovary after surgery. The patient will not be told which procedure has been performed in each ovary. The investigator will not know which procedure has been performed in each ovary until the end of the study. Only the surgeon will know which procedure is performed in each ovary.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Ovarian reserve</measure>
    <time_frame>7 months</time_frame>
    <description>Antral follicular count by ultrasound: number of antral follicles.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ovarian volume</measure>
    <time_frame>7 months</time_frame>
    <description>Ovarian volume will be assesses by ultrasound, units given with milliliters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Pregnancy rate will be recorded during the 6 months follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Endometriosis Ovary</condition>
  <arm_group>
    <arm_group_label>Stripping technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The endometrioma is removed according to standard surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CO2 (carbon dioxide) laser vaporisation</intervention_name>
    <description>CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma</description>
    <arm_group_label>Laser technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stripping technique</intervention_name>
    <description>Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue</description>
    <arm_group_label>Stripping technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 45.&#xD;
&#xD;
          -  Bilateral endometriomas.&#xD;
&#xD;
          -  Endometrioma size &gt; 3 cm.&#xD;
&#xD;
          -  Pain and/or infertility as indication to surgical treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cancer.&#xD;
&#xD;
          -  Suspected malignancy.&#xD;
&#xD;
          -  Evidence of premature ovarian failure.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francisco Carmona, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Francisco Carmona</investigator_full_name>
    <investigator_title>Head of Gynecology</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>No</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/NCT03826355
org study id: OR
nct id: NCT03826355
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endometriosis is a disease characterized by the presence of endometrial tissue outside the
      uterus cavity, causing important chronic pain and sterility in those patients suffering from
      it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis,
      which can coexist in the same patient, exist: deep infiltrating endometriosis (implants
      infiltrate > 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA).
      OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured
      during resection. Consequently, ovarian reserve decreases, worsening the reproductive
      prognosis of patients affected. The main objective of the present study is to compare laser
      versus conventional OMA excision according to ovarian reserve in a pairwise-data study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: The ultrasonographer will be blinded to the procedure performed in each ovary after surgery. The patient will not be told which procedure has been performed in each ovary. The investigator will not know which procedure has been performed in each ovary until the end of the study. Only the surgeon will know which procedure is performed in each ovary.
measure: Ovarian reserve
time frame: 7 months
description: Antral follicular count by ultrasound: number of antral follicles.
measure: Ovarian volume
time frame: 7 months
description: Ovarian volume will be assesses by ultrasound, units given with milliliters
measure: Pregnancy rate
time frame: 6 months after surgery
description: Pregnancy rate will be recorded during the 6 months follow-up
arm group label: Stripping technique
arm group type: Active Comparator
description: The endometrioma is removed according to standard surgery.
arm group label: Laser technique
arm group type: Experimental
description: The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser
intervention type: Procedure
intervention name: CO2 (carbon dioxide) laser vaporisation
description: CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma
arm group label: Laser technique
intervention type: Procedure
intervention name: Stripping technique
description: Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue
arm group label: Stripping technique
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Francisco Carmona, MD PhD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Francisco Carmona
investigator title: Head of Gynecology
mesh term: Endometriosis
sharing ipd: No