<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190219042755N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-06</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Antibiotic prophylaxis with doxycycline vs azithromycin prior to hysterosalpingography</public_title>
      <acronym>-</acronym>
      <scientific_title>Evaluation of Prophylactic efficacy and side effects of azithromycin versus doxycycline prior to hysterosalpingography in sub fertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53526</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization: Patients received doxycycline on even days and azithromycin on odd days, Blinding description: Participants: Provide tablets in unnamed medicine boxes for patients
Data Analyzer: Provide raw data based on code one (azithromycin) and code two (doxycycline).</study_design>
      <phase>4</phase>
      <hc_freetext>pelvic inflammatory disease.</hc_freetext>
      <i_freetext>Intervention 1: Control group: patients treated with doxycycline. Intervention 2: Intervention group: patients treated with azithromycin.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All individual data will be published after coding.

When:
Access starts 6 months after the results are published

To whom:
All people in the field of medicine and treatment are able to benefit from information

Conditions:
There are no access restrictions.

Where to obtain:
Send email to the author
Nz.rezaei4000@gmail.com

How to obtain:
One week after receiving the email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr  hospital. next to valiasr square. Arak city, iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 86 3222 2003</telephone>
        <email>Nz.rezaei4000@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr hospital. next to valiasr square. Arak city, iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 86 3222 2003</telephone>
        <email>nz.rezaei4000@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Sub fertile women 15-35 year old
Do not take any antibiotics during the week before the procedure</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of severe drug allergy to doxycycline and azithromycin (anaphylactic shock, cutaneous rash, and complications leading to hospitalization)
Active pelvic inflammation
Previously known history of pelvic infection
Known case of endometriosis
History of ectopic pregnancy
History of fallopian tube surgery
Pregnancy
Severe uterine bleeding</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N73.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female pelvic inflammatory disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: patients treated with doxycycline</i_keyword>
      <i_keyword>Intervention group: patients treated with azithromycin</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pelvic inflammatory disease is defined as a clinical diagnosis including fever and chills. Vaginal discharge. Abdominal pain. Timepoint: Evaluation of patients' symptoms for pelvic inflammatory infection 2 weeks after hysterosalpingography and in case of patients with  symptoms of pelvic inflammatory infection , Follow up patients for the next 2 weeks after symptoms resolve. Method of measurement: Visit the doctor by phone and check the patient's symptoms and if any of the symptoms are fever and chills, vaginal discharge and hypogastric pain, see a gynecologist and after examining the patient and prescribing appropriate treatment, follow up patients for 2 weeks until complete relief of symptoms.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug side effects, nausea and vomiting. Timepoint: Within two weeks after hysterosalpingography. Method of measurement: Phone call by the doctor and questions from the patient.</sec_outcome>
      <sec_outcome>Drug side effects, diarrhea. Timepoint: Within two weeks after hysterosalpingography. Method of measurement: Phone call by the doctor and questions from the patient.</sec_outcome>
      <sec_outcome>Drug side effects, abdominal pain. Timepoint: Within two weeks after hysterosalpingography. Method of measurement: Phone call by the doctor and questions from the patient.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-29</approval_date>
        <contact_name>Ethics committee of arak University of Medical Sciences</contact_name>
        <contact_address>Arak. The Great Prophet University Complex. Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
