<?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>IRCT201109136626N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-10-16</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparsion of effects of Gonadotropin Releasing Hormon Agonists and Antagonists in ART cycles in infertile patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparsion of effects of Gonadotropin Releasing Hormon Agonists and Antagonists in ART cycles in patients  35 years and older</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7066</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention 1: Exogenic gonadotropin Gonal F 75unit IM daily and Monogon 150 unit IM daily both of them at 2th_3th of cycle if ovarians are inactive and endometial thickness is less than 4mm (in both groups). Intervention 2: Gonadotropin Releasing Hormon Agonist (superfact) 0.5 cc subcutaneus    daily from 21th day of cycle until diameter of dominant  follicle reachs to 18_19mm  (in group one). Intervention 3: Gonadotropin Releasing Hormon Antagonist (cetrotide) 3.5mg subcutaneus single dose (in second group). Intervention 4: Human chorionic gonadothropin (hcg)(pregnil)1000 unit IM single dose ,when diameter of  dominant follicle reachs 18_19mm.</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>Seddighe Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al_zahra hospital,Bagh shomal crossroad,South artesh ave,tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1553 9161</telephone>
        <email>dr-abdollahi@tbzmed.ac.ir</email>
        <affiliation>AL-zahra hospital,Tabriz university of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seddighe Abdollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al_zahra hospital,Bagh shomal crossroad,South artesh ave,tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1553 9161</telephone>
        <email>dr-abdollahi@tbzmed.ac.ir</email>
        <affiliation>AL-zahra hospital,Tabriz university of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:infertile women older than 35 years who are conditions for art and have not any endocreean  desease  or hypertantion or polycistic ovarian syndrom(pcos) or history of endometriosis or any surgery of ovarian                                                                 Exclusion criteria: Infertile women smaller than 35 years old or  have any endocreean  desease  or hypertantion or polycistic ovarian syndrom(pcos) or history of endometriosis or any surgery of ovarian</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>no limit</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</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Exogenic gonadotropin Gonal F 75unit IM daily and Monogon 150 unit IM daily both of them at 2th_3th of cycle if ovarians are inactive and endometial thickness is less than 4mm (in both groups)</i_keyword>
      <i_keyword>Gonadotropin Releasing Hormon Agonist (superfact) 0.5 cc subcutaneus    daily from 21th day of cycle until diameter of dominant  follicle reachs to 18_19mm  (in group one)</i_keyword>
      <i_keyword>Gonadotropin Releasing Hormon Antagonist (cetrotide) 3.5mg subcutaneus single dose (in second group)</i_keyword>
      <i_keyword>Human chorionic gonadothropin (hcg)(pregnil)1000 unit IM single dose ,when diameter of  dominant follicle reachs 18_19mm</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of documented pregnancy. Timepoint: Two mounths after the end of intervention. Method of measurement: Sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rate of abortion before 12 weeks of pregnancy. Timepoint: Four mounths after the end of intervention. Method of measurement: Sonography.</sec_outcome>
      <sec_outcome>Severity of ovarian hyperstimulation syndrom. Timepoint: During one mounth after the end of intervention. Method of measurement: By examination and sonography.</sec_outcome>
      <sec_outcome>Rate of chemical pregnancy. Timepoint: Two weeks after end of intervention. Method of measurement: unit/litter.</sec_outcome>
      <sec_outcome>Prevalance of ovarian hyperstimulation syndrom. Timepoint: During one mounth after the end of intervention. Method of measurement: By examination and sonography.</sec_outcome>
      <sec_outcome>Number of follicles which are growth. Timepoint: During of intervention(36 hours after hcg injection). Method of measurement: Sonography.</sec_outcome>
      <sec_outcome>Number of the obtiened ovums. Timepoint: During the intervention(36 hours after hcg injection). Method of measurement: By counting.</sec_outcome>
      <sec_outcome>Estradiol levels. Timepoint: During the intervention(day of hcg injection). Method of measurement: pg/ml.</sec_outcome>
      <sec_outcome>Endometrial situation. Timepoint: During the intervention(day of hcg injection). Method of measurement: Sonography.</sec_outcome>
      <sec_outcome>Duration of the stimulation for induction ovulation. Timepoint: During the intervention. Method of measurement: Days.</sec_outcome>
      <sec_outcome>Number of the ampuls of gonadotropins used. Timepoint: During the intervention. Method of measurement: By counting.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-09-10</approval_date>
        <contact_name>Tabriz University of Medical Science</contact_name>
        <contact_address>Tabriz University of Medical Science ,Golgasht ave, Azadi ave Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
