<?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>IRCT20120716010297N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-11</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of methotrexate dose in the treatment of patients with ectopic pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of single-dose and multi-dose methotrexate in the treatment of patients with ectopic pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, eligible patients will be selected using non-probability consecutive. All the patients will randomly be assigned to two intervention groups using a computer-based random digit generator based on the consecutive admission numbers, Blinding description: Because of the use of different doses of the drug, the researcher is aware of the type of each group, but the person following the patient's condition and the statistician will not be aware of the type of group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Ectopic pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the multi-dose regimen, 1 mg / kg methotrexate will be injected on days of 1, 3, 5, and 7. It should be noted that in these days, βHCG titer will be measured before methotrexate injection, and methotrexate is prescribed if there was no reduction of less than 15%. Leucovorin will be injected at a dose of 0.1 mg / kg on days 2, 4, 6, and 8. Intervention 2: Intervention group: In the single-dose regimen after methotrexate injection, βHCG titers will be evaluated on days 4 and 7. If no reduction of 15% in βHCG titer was observed during this period, an additional dose will be injected on the seventh day. The dose of methotrexate in the single-dose method is 50 mg/m2 intramuscularly and is not require Leucovorin injection.</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 no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behnaz Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Hospital, Ostad Motahhari Street, Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3236 7001</telephone>
        <email>khani@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behnaz Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Hospital, Ostad Motahhari Street, Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3236 7001</telephone>
        <email>khani@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfaction with participating in the study
Confirmation of ectopic pregnancy by ultrasound and βHCG
Stable hemodynamic status
the gestational sac with the largest diameter of, 4 cm;
Existence of low free fluid in the abdominal and pelvic cavity based on ultrasound.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of active hepatitis
The presence of kidney disease
Use of immunosuppressive drugs
History of severe allergy to methotrexate
Leukopenia in patient CBC tests
Hematopoiesis disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O00.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ectopic pregnancy, 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>Intervention group: In the multi-dose regimen, 1 mg / kg methotrexate will be injected on days of 1, 3, 5, and 7. It should be noted that in these days, βHCG titer will be measured before methotrexate injection, and methotrexate is prescribed if there was no reduction of less than 15%. Leucovorin will be injected at a dose of 0.1 mg / kg on days 2, 4, 6, and 8.</i_keyword>
      <i_keyword>Intervention group: In the single-dose regimen after methotrexate injection, βHCG titers will be evaluated on days 4 and 7. If no reduction of 15% in βHCG titer was observed during this period, an additional dose will be injected on the seventh day. The dose of methotrexate in the single-dose method is 50 mg/m2 intramuscularly and is not require Leucovorin injection</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum βHCG level. Timepoint: On days 1, 3, 5 and 7 after injection of methotrexate. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Outcome of treatment. Timepoint: 6 weeks after starting treatment. Method of measurement: The outcome of treatment is assessed as follows: The success of single-dose treatment means a 5% reduction in serum hCG levels after one week of treatment and a serum level of less than 5 mIU / mL after 6 weeks of treatment. In the multi-dose regimen, a 15% decrease in hCG serum levels after 48 hours of treatment or after 4 therapeutic doses, or hCG serum levels less than 5 mIU / mL after 6 weeks of treatment will be regarded as success of treatment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Methotrexate complications such as Hair loss, gastroenteritis, Neutropenia, Fever, and Increase in liver enzyme. Timepoint: during the treatment up to six weeks after. Method of measurement: Clinical observation and doctor's diagnosis.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-24</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib Ave, Azadi Square. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
