<?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>IRCT20170315033085N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>letrozole and Dexametazon effect in Poly cystic ovarian syndrome patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Letrozole and Dexamethasone on pregnancy outcome in Poly cystic ovarian syndrome  patients candidate for intra uterine insemination: Randomized Clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25617</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Blinding description: Data was sent in form of two Group ( A and B )  to the person responsible for data analysis and analyzer wasn't not aware of the intervention.</study_design>
      <phase>1-2</phase>
      <hc_freetext>polycystic ovarian syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Control group: group A received letrozole  tablet ( abouraihan , Iran ) 5 mg from day 3 of menstrual cycle for 5 days .They were monitored hormonal and Sonographical on day 3 and day 12 of cycle. Ovulation was triggered with   injection  5000 Iu HCG (karma, Germany ) when the dominant follicle reached 18 mm in diameter. A single IUI was performed 36 hours later. The Luteal phase was supported with the progesterone suppository ( Cyclogest, 400 mg , Actavis, UK) . pregnancy test was don 14 day later. Intervention 2: Intervention group: group B received letrozol 5 mg(Abouraihan-Iran)  from 3th day of menstrual cycle for 5 days plus Dexamethazon tablet  0.5 mg (Iran hormone) for 10 days. They were monitored hormonal and Sonographical on day 3 and day 12 of cycle. Ovulation was triggered with   injection  5000 Iu HCG (karma, Germany ) when the dominant follicle reached 18 mm in diameter. A single IUI was performed 36 hours later. The Luteal phase was supported with the progesterone suppository ( Cyclogest, 400 mg , Actavis, UK) . pregnancy test was don 14 day later.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Malihe Afiat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Obestetrics department, Imam Reza hospital, Shariati square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9189757565</zip>
        <telephone>+98 51 3802 2608</telephone>
        <email>Afiatm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe Afiat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza hospital, Shariat square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91897-57565</zip>
        <telephone>+92 51 38022608</telephone>
        <email>Afiatm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>AGE: 25-35 years
at least one patent Fallopian tube
normal sperm analysis of spouse
presence of poly-cystic ovarian syndrome</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Smoking
underlying disease ( heart, kidney, liver or Endocrine)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome</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: group A received letrozole  tablet ( abouraihan , Iran ) 5 mg from day 3 of menstrual cycle for 5 days .They were monitored hormonal and Sonographical on day 3 and day 12 of cycle. Ovulation was triggered with   injection  5000 Iu HCG (karma, Germany ) when the dominant follicle reached 18 mm in diameter. A single IUI was performed 36 hours later. The Luteal phase was supported with the progesterone suppository ( Cyclogest, 400 mg , Actavis, UK) . pregnancy test was don 14 day later.</i_keyword>
      <i_keyword>Intervention group: group B received letrozol 5 mg(Abouraihan-Iran)  from 3th day of menstrual cycle for 5 days plus Dexamethazon tablet  0.5 mg (Iran hormone) for 10 days. They were monitored hormonal and Sonographical on day 3 and day 12 of cycle. Ovulation was triggered with   injection  5000 Iu HCG (karma, Germany ) when the dominant follicle reached 18 mm in diameter. A single IUI was performed 36 hours later. The Luteal phase was supported with the progesterone suppository ( Cyclogest, 400 mg , Actavis, UK) . pregnancy test was don 14 day later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Luteinizing hormone. Timepoint: Third and  12th  day of menstrual  cycle. Method of measurement: laboratory Test.</prim_outcome>
      <prim_outcome>Testestron. Timepoint: Third and  12th  day of menstrual  cycle. Method of measurement: laboratory Test.</prim_outcome>
      <prim_outcome>Anderestandion. Timepoint: Third and  12th  day of menstrual  cycle. Method of measurement: laboratory Test.</prim_outcome>
      <prim_outcome>Esteradiol. Timepoint: Third and  12th  day of menstrual  cycle. Method of measurement: laboratory Test.</prim_outcome>
      <prim_outcome>Pregnancy. Timepoint: 14  days after Intrauterine insemination. Method of measurement: laboratory Test, pregnancy test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dominant follicles. Timepoint: 12th day of Menestural cycle. Method of measurement: vaginal Sonography.</sec_outcome>
      <sec_outcome>Endometrium thickness. Timepoint: 12th day of Menestural cycle. Method of measurement: vaginal Sonography.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-02</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ghoraishi department, Daneshgah Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
