<?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>IRCT201104096152N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-07</date_registration>
      <primary_sponsor>Kordestan University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>Comparison of the effectiveness of clomiphene citrate, tamoxifen and letrozole in ovulation induction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of clomiphene citrate, tamoxifen and letrozole  in ovulation induction in infertility due to isolated unovulation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2007-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6588</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Group A received clomiphene 50 mg up to 150mg for 5-7days. Treatment starded with minimum dose and effect of drug monitored by sonography.  Drugs have been increased in dose and duration to achieve mature follicle 18mm. If patients achived pregnancy or were not responding to treatment with maximum dose for 7days or failed to concept after six months, treatment was discontinued. Intervention 2: Group B received tamoxifen 10 mg up to 30mg for 5-7days.  Treatment starded with minimum dose and effect of drug monitored by sonography. Drugs have been increased in dose and duration to achieve mature follicle 18mm. If patients achived pregnancy or were not responding to treatment with maximum dose for 7days or failed to concept after six months, treatment was discontinued. Intervention 3: Group C received letrozole 2.5 mg up to 7.5mg for 5-7days.  Treatment starded with minimum dose and effect of drug monitored by sonography. Drugs have been increased in dose and duration to achieve mature follicle 18mm. If patients achived pregnanvy or were not responding to treatment with maximum dose for 7days or failed to concept after six months, treatment was discontinued.</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>Fariba Seyedoshohadaei MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Obestetric &amp;Gynecology Department-Besat Hospital-sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 87 1328 2001</telephone>
        <email>F.SEYEDOSHOHADAEI@MUK.AC.IR</email>
        <affiliation>Besat Hospital -Kurdistan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Seyedoshohadaei MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Obestetric &amp;Gynecology Department-Besat Hospital-sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 87 1328 2001</telephone>
        <email>F.SEYEDOSHOHADAEI@MUK.AC.IR</email>
        <affiliation>Kurdistan University of Medical Sciences-Besat Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: women between 15 to 40 years old with infertility due to unovulation who refer to gynecologists, and they have normal semen analysis, hystrosalpingography and evidence of unovulation (include irregular menses and less than 14 mm folicle in sonography) &#13;
Exclusion criteria: Abnormal gondothrpins (LH, FSH) and prolactin, clinical finding of hyperandrogenism (including acne and hirsutism) and poly cystic appearance in sonography (including ovarian enlargement and subcoticular multiple small cysts)</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility associated with anovulation</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>Group A received clomiphene 50 mg up to 150mg for 5-7days. Treatment starded with minimum dose and effect of drug monitored by sonography.  Drugs have been increased in dose and duration to achieve mature follicle 18mm. If patients achived pregnancy or were not responding to treatment with maximum dose for 7days or failed to concept after six months, treatment was discontinued.</i_keyword>
      <i_keyword>Group B received tamoxifen 10 mg up to 30mg for 5-7days.  Treatment starded with minimum dose and effect of drug monitored by sonography. Drugs have been increased in dose and duration to achieve mature follicle 18mm. If patients achived pregnancy or were not responding to treatment with maximum dose for 7days or failed to concept after six months, treatment was discontinued</i_keyword>
      <i_keyword>Group C received letrozole 2.5 mg up to 7.5mg for 5-7days.  Treatment starded with minimum dose and effect of drug monitored by sonography. Drugs have been increased in dose and duration to achieve mature follicle 18mm. If patients achived pregnanvy or were not responding to treatment with maximum dose for 7days or failed to concept after six months, treatment was discontinued</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ovulation. Timepoint: monthly. Method of measurement: sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Live Birth. Timepoint: after delivery. Method of measurement: postpartum period.</sec_outcome>
      <sec_outcome>Pregnancy. Timepoint: after missed period. Method of measurement: serum BHCG measurment.</sec_outcome>
      <sec_outcome>Abortion. Timepoint: monthly in first half of pregnancy. Method of measurement: sonography.</sec_outcome>
      <sec_outcome>Twin Pregnancy. Timepoint: first prenatal care. Method of measurement: 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>Kordestan University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2006-06-03</approval_date>
        <contact_name>Kordestan University of Medical Sciences</contact_name>
        <contact_address>Besat Hospital-Keshavarz street-Sanandaj Sanandaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
