<?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>IRCT20220411054497N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-03</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of letrozole in EP treatment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison evaluation of letrozol metoretoxate treatment in patients with ectopic pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62895</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Ectopic Pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: includes a group of 24 people receiving letrozole for the treatment of EP, after explaining the benefits and side effects of both treatment methods and obtaining informed consent from them, 2.5 mg tablets every twelve hours for ten days receive letrozole. Intervention 2: The intervention group: includes a group of 24 people receiving methotrexate for the treatment of EP, who after explaining the benefits and complications of both treatment methods and obtaining informed consent from them, methotrexate ampoules with a dose of fifty mg per square meter It is done for them in a muscular way.</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:
Only information from the study participants will be published that is relevant to the outcome of the study and that they have been informed of their consent prior to the start of the study.

When:
The access period started at the beginning of 1401 and continues until the examination of 24 patients receiving letrozole treatment

To whom:
This information is available in the early stages for researchers and university-level research supervisors

Conditions:
This information is available in the early stages for researchers and university-level research supervisors

Where to obtain:
To receive comments, you can refer to the main project manager and then the executive project manager

How to obtain:
Submitting a request to the research director After reviewing by the project manager, a request to the research vice chancellor of the university

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sanaz Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Ave.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>sanazmlk97@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Lalouha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Hospital, Taleghani Ave.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3415613176</zip>
        <telephone>+98 28 3323 6374</telephone>
        <email>lalooha44@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Absence of active intra-abdominal bleeding
Adnexal mass below four centimeters
The person is healthy in terms of liver and kidney disease
B-HCG levels should be less than 5000
The patient should not breastfeed</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>If the patient is a candidate for surgery
If the patient does not consent to participate in the study</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>The intervention group: includes a group of 24 people receiving letrozole for the treatment of EP, after explaining the benefits and side effects of both treatment methods and obtaining informed consent from them, 2.5 mg tablets every twelve hours for ten days receive letrozole</i_keyword>
      <i_keyword>The intervention group: includes a group of 24 people receiving methotrexate for the treatment of EP, who after explaining the benefits and complications of both treatment methods and obtaining informed consent from them, methotrexate ampoules with a dose of fifty mg per square meter It is done for them in a muscular way</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>B-HCG. Timepoint: 0 day fourth day and seventh day. Method of measurement: Blood test and B-HCG check request.</prim_outcome>
      <prim_outcome>Duration of zeroing of B-HCG in the two groups of letrozole and methotrexate. Timepoint: From day one of B-HCG assay until the B-HCG marker is zero. Method of measurement: Blood test and B-HCG check request.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hbg. Timepoint: The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero. Method of measurement: Taking blood tests and checking CBC.</sec_outcome>
      <sec_outcome>WBC. Timepoint: The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero. Method of measurement: Taking blood tests and checking CBC.</sec_outcome>
      <sec_outcome>Platelets. Timepoint: The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero. Method of measurement: Taking blood tests and checking CBC.</sec_outcome>
      <sec_outcome>LFT. Timepoint: The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero. Method of measurement: Blood test and blood biochemistry check.</sec_outcome>
      <sec_outcome>BUN. Timepoint: The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero. Method of measurement: Blood test and blood biochemistry check.</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>Qazvin University of Medical Sciences Research Assistant</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-22</approval_date>
        <contact_name>Ethics of committee of Qazvin University of Medical sciences</contact_name>
        <contact_address>Bahonar Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
