<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/NCT04452123</url>
  </required_header>
  <id_info>
    <org_study_id>GPKENDO2001</org_study_id>
    <nct_id>NCT04452123</nct_id>
  </id_info>
  <brief_title>Endometrioma Treatment and Ovarian Function</brief_title>
  <acronym>EnTOF</acronym>
  <official_title>Endometrioma Treatment and Ovarian Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charles University, Czech Republic</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>
      Ovarian endometriosis (endometrioma) can be a cause of subfertility. According to European&#xD;
      Society of Human Reproduction and Embryology (ESHRE) guidelines, surgery for endometrioma is&#xD;
      recommended when an endometrioma is more than 3 cm in diameter because this management is&#xD;
      associated with better spontaneous conception rates. Nevertheless, surgery can also be&#xD;
      potentially associated with a risk of destruction of functional ovarian tissue and reduction&#xD;
      in ovarian reserve.&#xD;
&#xD;
      Anti-müllerian hormone (AMH) is a member of the Transforming Growth Factor beta family and is&#xD;
      expressed by the small (&lt;8 mm) pre-antral and early antral follicles. The AMH level reflects&#xD;
      the size of the primordial follicle pool, and may be the best biochemical marker of ovarian&#xD;
      function across an array of clinical situations Its level in serum is almost stable between&#xD;
      20 and 35 years of the woman´s life, unless using hormonal contraception and / or they suffer&#xD;
      with Polycystic ovarian syndrome (PCOS). The level of AMH is also a useful indicator for the&#xD;
      prediction chances of success of spontaneous or assisted conceptions. However, there paucity&#xD;
      of data regarding changes in serum levels of AMH following surgery for endometrioma.&#xD;
&#xD;
      An alternative way for estimating ovarian reserve is quantifying ovarian mass with using&#xD;
      standard 3D transvaginal ultrasound calculation (OVM) and assessment of antral follicular&#xD;
      count.&#xD;
&#xD;
      The gold standard of endometrioma surgery is laparoscopic excision with suture or gentle&#xD;
      coagulation of the rest of ovary or by the use of laparoscopic treatment with argon plasma&#xD;
      energy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AMH</measure>
    <time_frame>3 days,3-5 week postop., 3 months postop., 1 year (optional)</time_frame>
    <description>Changing of anti-müllerian hormon assay postop. in µg/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antral follicle count (AFC)</measure>
    <time_frame>3 months, 1 year</time_frame>
    <description>Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Both ovarian volume</measure>
    <time_frame>3 months, 1 year</time_frame>
    <description>Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Endometrioma</condition>
  <arm_group>
    <arm_group_label>Argon plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with endometrioma treated with laparoscopic argon plasma energy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stripping and suture/coagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic argon plasma treatment of endometrioma</intervention_name>
    <description>Laparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible</description>
    <arm_group_label>Argon plasma</arm_group_label>
    <arm_group_label>Stripping and suture/coagulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary</intervention_name>
    <description>Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.</description>
    <arm_group_label>Argon plasma</arm_group_label>
    <arm_group_label>Stripping and suture/coagulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with endometrioma 3cm and more in diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  using hormonal contraception or other hormonal treatment last 6 months&#xD;
&#xD;
          -  suffer with polycystic ovarian syndrome&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Humplik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charles university in Pilsen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jan Humplik, MD</last_name>
    <phone>420377105254</phone>
    <email>humplikj@fnplzen.cz</email>
  </overall_contact>
  <location>
    <facility>
      <name>Departement of gynecology and obstetrics, University hospital in Pilsen</name>
      <address>
        <city>Pilsen</city>
        <zip>30408</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <contact>
      <last_name>Jan Humplik, MD</last_name>
      <phone>420377105240</phone>
      <email>humplikj@fnplzen.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 27, 2020</last_update_submitted>
  <last_update_submitted_qc>June 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Jan Humplik, MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Endometrioma</keyword>
  <keyword>AMH</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>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/NCT04452123
org study id: GPKENDO2001
nct id: NCT04452123
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ovarian endometriosis (endometrioma) can be a cause of subfertility. According to European
      Society of Human Reproduction and Embryology (ESHRE) guidelines, surgery for endometrioma is
      recommended when an endometrioma is more than 3 cm in diameter because this management is
      associated with better spontaneous conception rates. Nevertheless, surgery can also be
      potentially associated with a risk of destruction of functional ovarian tissue and reduction
      in ovarian reserve.

      Anti-müllerian hormone (AMH) is a member of the Transforming Growth Factor beta family and is
      expressed by the small (<8 mm) pre-antral and early antral follicles. The AMH level reflects
      the size of the primordial follicle pool, and may be the best biochemical marker of ovarian
      function across an array of clinical situations Its level in serum is almost stable between
      20 and 35 years of the woman´s life, unless using hormonal contraception and / or they suffer
      with Polycystic ovarian syndrome (PCOS). The level of AMH is also a useful indicator for the
      prediction chances of success of spontaneous or assisted conceptions. However, there paucity
      of data regarding changes in serum levels of AMH following surgery for endometrioma.

      An alternative way for estimating ovarian reserve is quantifying ovarian mass with using
      standard 3D transvaginal ultrasound calculation (OVM) and assessment of antral follicular
      count.

      The gold standard of endometrioma surgery is laparoscopic excision with suture or gentle
      coagulation of the rest of ovary or by the use of laparoscopic treatment with argon plasma
      energy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: AMH
time frame: 3 days,3-5 week postop., 3 months postop., 1 year (optional)
description: Changing of anti-müllerian hormon assay postop. in µg/L
measure: Antral follicle count (AFC)
time frame: 3 months, 1 year
description: Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle
measure: Both ovarian volume
time frame: 3 months, 1 year
description: Ultrasound volume of both ovaries in cm^3, measured 3-5. day of menstrual cycle
arm group label: Argon plasma
arm group type: Experimental
description: Patients with endometrioma treated with laparoscopic argon plasma energy.
arm group label: Stripping and suture/coagulation
arm group type: Experimental
description: Patients with endometrioma treated with laparoscopic excision with suture or gentle coagulation of the rest of ovary.
intervention type: Procedure
intervention name: Laparoscopic argon plasma treatment of endometrioma
description: Laparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible
arm group label: Argon plasma
arm group label: Stripping and suture/coagulation
intervention type: Procedure
intervention name: Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary
description: Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.
arm group label: Argon plasma
arm group label: Stripping and suture/coagulation
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
last name: Jan Humplik, MD
role: Principal Investigator
affiliation: Charles university in Pilsen
last name: Jan Humplik, MD
phone: 420377105254
email: humplikj@fnplzen.cz
facility: 
contact: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Jan Humplik, MD
investigator title: Principal investigator
mesh term: Endometriosis
sharing ipd: No