<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/NCT03786588</url>
  </required_header>
  <id_info>
    <org_study_id>CPPVM</org_study_id>
    <nct_id>NCT03786588</nct_id>
  </id_info>
  <brief_title>Patients With Chronic Pelvic Pain With Vaginal Microbiota</brief_title>
  <official_title>Chronic Pelvic Pain With Vaginal Microbiota in Gestational Women Without HPV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      Vaginal microorganisms play an important role in the occurrence and development of many&#xD;
      diseases, such as persistent infection of high-risk human papillomavirus (HR-HPV) causing&#xD;
      cervical intraepithelial neoplasia and cervical cancer, and the role of microorganisms in&#xD;
      chronic prostatitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 25, 2018</start_date>
  <completion_date type="Anticipated">December 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 25, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Vaginal microbiota difference</measure>
    <time_frame>one year</time_frame>
    <description>Vaginal microbiota difference between the women with or without CPP, and all the cases are cervical HPV negative.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Pelvic Pain</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Vaginal microbiota in gestation CPP women without HPV infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GroupB</arm_group_label>
    <description>Vaginal microbiota in gestation women without CPP and HPV infection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>The patients with the negative results of HPV infection, and assigned to different group according to the CPP manifestation.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Gestational participants without HPV infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those are aged 20 to 45 years old, have vaginal intercourse more than 3 years, and&#xD;
             aren't in menstrual, pregnancy or puerperium period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those are aged more than 45 years old without HPV infection in the last one year,&#xD;
             having no vaginal intercourse, and those can't cooperate the examiner. Women who are&#xD;
             HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like&#xD;
             diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction),&#xD;
             or have severe mental illness and malignant tumors are also excluded. At the same&#xD;
             time, all the participants should meet the following requirements: no vagina douching&#xD;
             within last 2 days, no vaginal intercourse within last 3 days, no systemic application&#xD;
             of antifungal agents or antibiotics or pessaries within last 14 days of sampling.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Shu Wang</last_name>
    <phone>+86-18810535568</phone>
    <email>chaoxp_pumch@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Xu</last_name>
      <phone>+86-010-69156874</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>shuwang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT03786588
org study id: CPPVM
nct id: NCT03786588
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vaginal microorganisms play an important role in the occurrence and development of many
      diseases, such as persistent infection of high-risk human papillomavirus (HR-HPV) causing
      cervical intraepithelial neoplasia and cervical cancer, and the role of microorganisms in
      chronic prostatitis.
observational model: Case-Control
time perspective: Prospective
measure: Vaginal microbiota difference
time frame: one year
description: Vaginal microbiota difference between the women with or without CPP, and all the cases are cervical HPV negative.
arm group label: Group A
description: Vaginal microbiota in gestation CPP women without HPV infection
arm group label: GroupB
description: Vaginal microbiota in gestation women without CPP and HPV infection
intervention type: Other
intervention name: Observation
description: The patients with the negative results of HPV infection, and assigned to different group according to the CPP manifestation.
arm group label: Group A
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
last name: Shu Wang
phone: +86-18810535568
email: chaoxp_pumch@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: shuwang
investigator title: Associate Professor
mesh term: Pelvic Pain