<?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>IRCT2013110915342N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-12</date_registration>
      <primary_sponsor>Avicenna Research Institute</primary_sponsor>
      <public_title>The effect of Prednisolone in reducing of recurrent abortion</public_title>
      <acronym></acronym>
      <scientific_title>A randomized controlled trial of  prednisolone for women with idiopathic recurrent miscarriage and raised levels of Peripheral natural killer cells .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14633</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Idiopathic Recurrent Abortion.</hc_freetext>
      <i_freetext>Intervention 1: Case group are treated with prednisolone with this protocol: prednisolone 2 months before taking action to pregnancy; first week 20 mg daily; second week 15 mg daily ; third to seventh week 10 mg daily ; eighth week 5 mg daily.Then recheck NK-cell density , if there is suitable response, taking action to pregnancy will be allowed .After positive pregnancy test ,restarting prednisolone or placebo with this protocol:10mg daily until 14th week of gestational age ,when the dose will be tapered off and stopped. In addition, both of groups equally are treated with empirical treatment which have been  effective in past studies of idiopathic recurrent abortion, including : ASA-FA5mg-vit B6. Intervention 2: Control group with placebo before and during pregnancy ;with this protocol: placebo 2 months before taking action to pregnancy; first week 20 mg daily; second week 15 mg daily ; third to seventh week 10 mg daily ; eighth week 5 mg daily.Then recheck NK-cell density , if there is suitable response, taking action to pregnancy will be allowed .After positive pregnancy test ,restarting placebo with this protocol:10mg daily until 14th week of gestational age ,when the dose will be tapered off and stopped. In addition, both of groups equally are treated with empirical treatment which have been effective in past studies of idiopathic recurrent abortion, including : ASA-FA5mg-vit B6.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Rashin Zargham</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 97, Yakhchal Avenue, Shariati Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>r.zargham@avicenna.ac.ir; zargham_dr@yahoo.com</email>
        <affiliation>Avicenna Infertility and Recurrent Aborsion Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fatemeh Razzaghi, Dr.Saeed Zarei, Dr. Rashin zargham</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 97, Yakhchal Avenue, Shariati Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>r.zargham@avicenna.ac.ir; zargham_dr@yahoo.com</email>
        <affiliation>Avicenna Infertility and Recurrent Aborsion Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: female gender;  being a case of idiopathic abortion; in flow cytometry of peripheral blood, CD56 more than 12 or CD 16/56 more than 8.&#13;
Exclusion criteria: age less than 20 or more than 40 years old; having less than 2 abortions;  history of abortion more than 20w of gestational age; uterine disorder; chromosomal disorder in couples; antiphospholipid syndrome; contraindication of corticosteroid; abnormal thyroid function test result.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Miscarriage</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>Case group are treated with prednisolone with this protocol: prednisolone 2 months before taking action to pregnancy; first week 20 mg daily; second week 15 mg daily ; third to seventh week 10 mg daily ; eighth week 5 mg daily.Then recheck NK-cell density , if there is suitable response, taking action to pregnancy will be allowed .After positive pregnancy test ,restarting prednisolone or placebo with this protocol:10mg daily until 14th week of gestational age ,when the dose will be tapered off and stopped. In addition, both of groups equally are treated with empirical treatment which have been  effective in past studies of idiopathic recurrent abortion, including : ASA-FA5mg-vit B6.</i_keyword>
      <i_keyword>Control group with placebo before and during pregnancy ;with this protocol: placebo 2 months before taking action to pregnancy; first week 20 mg daily; second week 15 mg daily ; third to seventh week 10 mg daily ; eighth week 5 mg daily.Then recheck NK-cell density , if there is suitable response, taking action to pregnancy will be allowed .After positive pregnancy test ,restarting placebo with this protocol:10mg daily until 14th week of gestational age ,when the dose will be tapered off and stopped. In addition, both of groups equally are treated with empirical treatment which have been effective in past studies of idiopathic recurrent abortion, including : ASA-FA5mg-vit B6.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abortion. Timepoint: 12th and 20th weeks of gestation. Method of measurement: Patients file.</prim_outcome>
      <prim_outcome>Live birth. Timepoint: After Birth. Method of measurement: Patient file.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Peripheral Natural Killer Cell. Timepoint: Before intervention, 2 months after intervention, 8th, 12th, 20th weeks of gestation. Method of measurement: Flow cytometry.</sec_outcome>
      <sec_outcome>Chemical pregnancy. Timepoint: 1 week after retardation of mens. Method of measurement: Positive beta-hcg test.</sec_outcome>
      <sec_outcome>Pre eclampsia. Timepoint: After 20th week of gestation. Method of measurement: Blood pressure measuring.</sec_outcome>
      <sec_outcome>Drug Complications. Timepoint: After Treatment. Method of measurement: Patients files.</sec_outcome>
      <sec_outcome>Gestational Diabetes. Timepoint: After 20th week of gestation. Method of measurement: FBS, GCT, GTT.</sec_outcome>
      <sec_outcome>IUGR. Timepoint: After 28th week of gestation. Method of measurement: Obstetrical ultrasound scan.</sec_outcome>
      <sec_outcome>Clinical Pregnancy. Timepoint: After 5-6 th week of gestation. Method of measurement: Obstetrical Ultra Sound Scan.</sec_outcome>
      <sec_outcome>Ongoing Pregnancy. Timepoint: After 7th week. Method of measurement: Obstetrical Ultrasound Scan.</sec_outcome>
      <sec_outcome>Gestational age at delivery. Timepoint: After 24th week of gestation. Method of measurement: Patient file.</sec_outcome>
      <sec_outcome>Feotal Abnormality. Timepoint: At 20th weeks gestation. Method of measurement: Anomaly Ultrasound Scan.</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>Avicenna Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-22</approval_date>
        <contact_name>Avicenna Research Institute Ethical Committee</contact_name>
        <contact_address>Avicenna Research Institute, Evin Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
