<?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>IRCT20160523028008N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-21</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Induction of abortion in the first trimester by misoprostol or misoprostol with different dose of letrozo</public_title>
      <acronym></acronym>
      <scientific_title>Induction of abortion in the first trimester by misoprostol or misoprostol with different dose of letrozol In women referring to Akbarabadi hospital in 1398-1399</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54861</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to interventions and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on four sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: Patients are not aware of the type of intervention, so the study is a one-way blind.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Medical abortion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Letrozole 10 mg and misoprostol tablets 800 mg three doses at intervals of three hours vaginal made by Abureyhan Pharmaceutical Company, Iran. Intervention 2: Intervention group: Letrozole 5 mg and misoprostol tablets 800 mg three doses at intervals of three hours vaginal made by Abureyhan Pharmaceutical Company, Iran. Intervention 3: Control group: Placebo and misoprostol tablets 800 mg three doses at intervals of three hours vaginal made by Abureyhan Pharmaceutical Company, Iran.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is not a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojgan Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>shahid Akbar Abadi Hospital,Ferdowsi Station, Molavi st, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1168743514</zip>
        <telephone>+98 21 6655 2972</telephone>
        <email>mokhtari.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojgan Mokhtari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Akbar Abadi Hospital,Ferdowsi Station, Molavi st, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1168743514</zip>
        <telephone>+98 912 761 1381</telephone>
        <email>mokhtari.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age older than 18 years
Gestational age based on ultrasound findings less than 12 weeks
Patient and spouse satisfaction
Lack of systemic diseases such as hypertension, kidney disease
Hemoglobin greater than or equal to 10 g / l, diastolic blood pressure less than 95 mm Hg</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having an IUD
Any allergy to letrozole or misoprostol
Liver disease, kidney failure, high blood pressure and asthma
Convulsions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O08.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complication following abortion and ectopic and molar pregnancy,unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Letrozole 10 mg and misoprostol tablets 800 mg three doses at intervals of three hours vaginal made by Abureyhan Pharmaceutical Company, Iran</i_keyword>
      <i_keyword>Intervention group: Letrozole 5 mg and misoprostol tablets 800 mg three doses at intervals of three hours vaginal made by Abureyhan Pharmaceutical Company, Iran</i_keyword>
      <i_keyword>Control group: Placebo and misoprostol tablets 800 mg three doses at intervals of three hours vaginal made by Abureyhan Pharmaceutical Company, Iran</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The interval between induction and abortion beginning and opening of cervical internal os. Timepoint: Until 24 hours after receiving Misoprostol, every 1 hou. Method of measurement: Sonography.</prim_outcome>
      <prim_outcome>The interval between induction and complete abortion. Timepoint: Until 24 hours after receiving Misoprostol, every 1 hour. Method of measurement: Sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gastrointestinal problems (nausea or vomiting). Timepoint: From receiving Letrozole until 24 hours after receiving Misoprostol. Method of measurement: Objective.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-21</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat High Way Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
