<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/NCT03760926</url>
  </required_header>
  <id_info>
    <org_study_id>ULTRA</org_study_id>
    <nct_id>NCT03760926</nct_id>
  </id_info>
  <brief_title>A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility</brief_title>
  <official_title>ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>May Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>May Health</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>
      The objective of this study is to provide preliminary evidence for the safety and&#xD;
      effectiveness of the May Health Kit in transvaginal ablation of ovarian tissue under&#xD;
      ultrasound visualization in women with infertility due to polycystic ovary syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications</measure>
    <time_frame>Up to 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.</measure>
    <time_frame>During procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of ovulation following the procedure</measure>
    <time_frame>Up to 3 months after procedure</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered during procedure</measure>
    <time_frame>At procedure, 7 days, 30 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Usability of the May Health Kit</measure>
    <time_frame>During procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered post-procedure</measure>
    <time_frame>At 30 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>May Health Procedure time</measure>
    <time_frame>During procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Occurrence of ovulation following the procedure</measure>
    <time_frame>Up to 6 months after procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Pregnancy</measure>
    <time_frame>At 3, 6, 9 12 and 24 months</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>May Health Procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>May Health Procedure performed with use of the May Health Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>May Health Kit</intervention_name>
    <description>The intervention consists in the realisation of the May Health Procedure using the May Health Kit, which comprises two elements: a disposable device (May Health Device) and a radiofrequency (RF) energy generator (May Health System). The May Health Device is a short-term invasive device delivered and positioned through the vagina to deliver RF energy inside the ovary in order to ablate ovarian tissue.</description>
    <arm_group_label>May Health Procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Candidates for this study must meet ALL of the following criteria:&#xD;
&#xD;
        Inclusion criteria for female participants:&#xD;
&#xD;
          1. Age: ≥ 18 to ≤ 40 years&#xD;
&#xD;
          2. Diagnostic of PCOS confirmed by at least 2 of 3 Rotterdam criteria, defined as:&#xD;
&#xD;
             2.1 Infertility associated with chronic anovulation or oligomenorrhea, defined as&#xD;
             spontaneous intermenstrual periods of ≥35 days or a total of ≤9 menses per year 2.2&#xD;
             Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or follicle number per&#xD;
             ovary of ≥ 20) 2.3 Evidence of hyperandrogenaemia: either clinical (hirsutism or acne)&#xD;
             or biochemical (raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, or&#xD;
             FAI &gt; 4)&#xD;
&#xD;
          3. Ovarian accessibility: determined by ability to bring transvaginal ultrasound&#xD;
             transducer into close proximity to ovaries&#xD;
&#xD;
          4. Resistance to first-line pharmacological treatment, defined as at least 2 consecutive&#xD;
             non-ovulatory cycles, including at least 1 cycle at the highest dose deemed clinically&#xD;
             relevant for the patient&#xD;
&#xD;
          5. At least one patent tube and normal uterine cavity as determined by sonohysterogram,&#xD;
             hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years&#xD;
&#xD;
          6. Willing to comply with protocol-specified follow-up evaluation&#xD;
&#xD;
          7. Signed informed consent&#xD;
&#xD;
             Couple inclusion criteria:&#xD;
&#xD;
          8. Normal sperm parameters based on WHO 2000 criteria (concentration⩾ 15 million/mL,&#xD;
             motility A+B ⩾ 32%, normal forms ⩾ 4%).&#xD;
&#xD;
          9. Ability to have regular intercourse during the study&#xD;
&#xD;
         10. No previous sterilization procedures (vasectomy, tubal ligation) that have been&#xD;
             reversed&#xD;
&#xD;
        Candidates will be excluded from the study if ANY of the following conditions apply:&#xD;
&#xD;
          1. Pregnant, parturient or breastfeeding women&#xD;
&#xD;
          2. Marked obesity, BMI &gt; 35&#xD;
&#xD;
          3. Marked hyperandrogenism (FAI &gt; 15)&#xD;
&#xD;
          4. Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients&#xD;
             with known or suspected periovarian adhesions.&#xD;
&#xD;
          5. Subject with pacemaker, defibrillator or other active implant&#xD;
&#xD;
          6. Subject is currently participating in another investigational drug or device study&#xD;
             that clinically interferes with the endpoints of this study&#xD;
&#xD;
          7. Lack of capacity to give informed consent (individuals deprived of their liberty&#xD;
             subject to a legal protection measure or who are unable to express their consent,&#xD;
             individuals under guardianship or curatorship)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Saint-Pierre</name>
      <address>
        <city>Bruxelles</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+32 2 535 48 56</phone>
      <email>katty.renard@stpierre-bru.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CU Saint-Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+32 2 764 78 03</phone>
      <email>patricia.vanaken@uclouvain.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bicetre Hospital</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study coordinator</last_name>
      <phone>+330145217717</phone>
      <email>solene.fabre@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Derby Hospital</name>
      <address>
        <city>Derby</city>
        <zip>DE22 3NE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>+441332788664</phone>
      <email>laura.johnson63@nhs.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Liverpool Women Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>L8 7SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study coordinator</last_name>
      <phone>+44 151 708 9988</phone>
      <email>amy.hughes@lwh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>00441142268050</phone>
      <email>liz.taylor15@nhs.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anovulatory infertility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03760926
org study id: ULTRA
nct id: NCT03760926
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to provide preliminary evidence for the safety and
      effectiveness of the May Health Kit in transvaginal ablation of ovarian tissue under
      ultrasound visualization in women with infertility due to polycystic ovary syndrome.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications
time frame: Up to 30 days
measure: Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.
time frame: During procedure
measure: Occurrence of ovulation following the procedure
time frame: Up to 3 months after procedure
measure: Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered during procedure
time frame: At procedure, 7 days, 30 days
measure: Usability of the May Health Kit
time frame: During procedure
measure: Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered post-procedure
time frame: At 30 days
measure: May Health Procedure time
time frame: During procedure
measure: Occurrence of ovulation following the procedure
time frame: Up to 6 months after procedure
measure: Pregnancy
time frame: At 3, 6, 9 12 and 24 months
arm group label: May Health Procedure
arm group type: Experimental
description: May Health Procedure performed with use of the May Health Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.
intervention type: Device
intervention name: May Health Kit
description: The intervention consists in the realisation of the May Health Procedure using the May Health Kit, which comprises two elements: a disposable device (May Health Device) and a radiofrequency (RF) energy generator (May Health System). The May Health Device is a short-term invasive device delivered and positioned through the vagina to deliver RF energy inside the ovary in order to ablate ovarian tissue.
arm group label: May Health Procedure
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Belgium
country: France
country: United Kingdom
responsible party type: Sponsor
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
sharing ipd: Undecided