<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/NCT04447625</url>
  </required_header>
  <id_info>
    <org_study_id>1A</org_study_id>
    <nct_id>NCT04447625</nct_id>
  </id_info>
  <brief_title>Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics</brief_title>
  <official_title>Introducing Intrauterine Antibiotic Infusion as a Novel Approach in Effectively Treating Chronic Endometritis and Restoring Reproductive Dynamics: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genesis Athens Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genesis Athens Clinic</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic Endometritis (CE) is related to infertility and entails a challenging management.&#xD;
      This study investigates the treatment of off-label intrauterine antibiotic infusion (IAI)&#xD;
      combined with oral antibiotic administration (OAA), and it assesses respective performance&#xD;
      against the gold standard treatment of OAA. Data sourced herein reports on treatment&#xD;
      efficiency and fertility restoration for both patients aiming to conceive naturally or via In&#xD;
      Vitro fertilization (IVF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">January 3, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>Phase 2</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>Treatment efficiency rate</measure>
    <time_frame>Treatment efficiency rate was assessed immediately after treatment completion</time_frame>
    <description>Negative results in all three diagnostic evaluations of CE namely hysteroscopic investigation, endometrial biopsy, along with histological analysis and microbiological culture indicating successful treatment of CE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side-effects rate</measure>
    <time_frame>Side-effects were monitored from treatment initiation until completion of treatment. Treatment duration: 14 days for Arm 1 and 30 days for Arm 2</time_frame>
    <description>Number of reports of minimal, mild, and moderate side-effects per treated patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>Clinical pregnancy rate was assessed 6-7 weeks following last menstrual period for patients that achieved a pregnancy. A time frame of 6 months was allowed for patients to achieve a pregnancy post treatment.</time_frame>
    <description>Clinical pregnancy rate was defined by the presence of a fetal heartbeat at 6-7 weeks following last menstrual period (LMP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period.</time_frame>
    <description>Number of live births per clinical pregnancy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Chronic Endometritis</condition>
  <arm_group>
    <arm_group_label>CE patients receiving OAA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CE patients receiving OAA and IAI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral antibiotic administration</intervention_name>
    <description>per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day for 14 days and metronidazole of 500mg twice a day for 14 days</description>
    <arm_group_label>CE patients receiving OAA</arm_group_label>
    <arm_group_label>CE patients receiving OAA and IAI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrauterine antibiotic infusion</intervention_name>
    <description>intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml</description>
    <arm_group_label>CE patients receiving OAA and IAI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Positive diagnosis of CE&#xD;
&#xD;
          -  Recurrent Pregnancy Loss (RPL) or Recurrent Implantation Failure (RIF)&#xD;
&#xD;
          -  No previous live birth&#xD;
&#xD;
          -  FSH and LH levels -evaluated on day 2 of the menstrual cycle- &lt;12 IU/ml&#xD;
&#xD;
          -  AMH levels &gt;1.1ng/ml&#xD;
&#xD;
          -  Progesterone levels -evaluated on day 21 of the menstrual cycle- &gt; 2 and &lt;25 ng/ml&#xD;
&#xD;
          -  18.5&lt;BMI&lt;29.9&#xD;
&#xD;
          -  18&lt;Patients' age&lt;40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)&#xD;
&#xD;
          -  Current or previous cancer diagnosis&#xD;
&#xD;
          -  Auto-immune, genetic or reproductive disorders&#xD;
&#xD;
          -  Reproductive history of pregnancy loss due to genetic abnormalities&#xD;
&#xD;
          -  Male factor infertility diagnosis&#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>Human Reproduction LTD</name>
      <address>
        <city>Athens</city>
        <state>Holargos</state>
        <zip>15562</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CE treatment</keyword>
  <keyword>infertility</keyword>
  <keyword>oral antibiotic administration</keyword>
  <keyword>intrauterine antibiotic infusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Antibiotics, Antitubercular</mesh_term>
  </intervention_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/NCT04447625
org study id: 1A
nct id: NCT04447625
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Chronic Endometritis (CE) is related to infertility and entails a challenging management.
      This study investigates the treatment of off-label intrauterine antibiotic infusion (IAI)
      combined with oral antibiotic administration (OAA), and it assesses respective performance
      against the gold standard treatment of OAA. Data sourced herein reports on treatment
      efficiency and fertility restoration for both patients aiming to conceive naturally or via In
      Vitro fertilization (IVF).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment efficiency rate
time frame: Treatment efficiency rate was assessed immediately after treatment completion
description: Negative results in all three diagnostic evaluations of CE namely hysteroscopic investigation, endometrial biopsy, along with histological analysis and microbiological culture indicating successful treatment of CE
measure: Side-effects rate
time frame: Side-effects were monitored from treatment initiation until completion of treatment. Treatment duration: 14 days for Arm 1 and 30 days for Arm 2
description: Number of reports of minimal, mild, and moderate side-effects per treated patients
measure: Clinical pregnancy rate
time frame: Clinical pregnancy rate was assessed 6-7 weeks following last menstrual period for patients that achieved a pregnancy. A time frame of 6 months was allowed for patients to achieve a pregnancy post treatment.
description: Clinical pregnancy rate was defined by the presence of a fetal heartbeat at 6-7 weeks following last menstrual period (LMP)
measure: Live birth rate
time frame: A time frame of 40-41 weeks was allowed to assess live birth rate following patients' last menstrual period.
description: Number of live births per clinical pregnancy
arm group label: CE patients receiving OAA
arm group type: Active Comparator
description: Patients diagnosed with CE receiving the gold standard treatment of oral antibiotic administration (OAA)
arm group label: CE patients receiving OAA and IAI
arm group type: Experimental
description: Patients diagnosed with CE receiving a combination of the gold standard treatment of oral antibiotic administration (OAA) and intrauterine antibiotic infusion (IAI)
intervention type: Drug
intervention name: Oral antibiotic administration
description: per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day for 14 days and metronidazole of 500mg twice a day for 14 days
arm group label: CE patients receiving OAA
arm group label: CE patients receiving OAA and IAI
intervention type: Drug
intervention name: Intrauterine antibiotic infusion
description: intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml
arm group label: CE patients receiving OAA and IAI
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Endometritis
mesh term: Anti-Bacterial Agents
mesh term: Antibiotics, Antitubercular
sharing ipd: No