<?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>IRCT2014021611430N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-03-17</date_registration>
      <primary_sponsor>Infertility and recurrent abortion treatment center of Avicenna</primary_sponsor>
      <public_title>Efficacy of embryo culture  on freezed embryos and  pregnancy outcome</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of efficacy of GM-CSF in embryo culture for freezed embryos in embryo development and pregnancy outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11703</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>4</phase>
      <hc_freetext>In vitro fertilization.</hc_freetext>
      <i_freetext>In intervention group , embryos after thawing will cultured in medium with growth factor and in control group they will cultured in medium without growth factor. IN two groups will evaluate Blastocyst development and embryo quality..</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>Zafardoust Simin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>97 no.Yakhchal street, Shariati Street.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19419113194</zip>
        <telephone>+98 21 2264 4701</telephone>
        <email>Sadeghi@avicenna.ac.ir s.zafardoost@avicenna.ac.ir</email>
        <affiliation>Infertility and recurrent abortion of Avicenna</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sadeghi Mohammad Reza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>97 no.Yakhchal street, Shariati Street.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19419113194</zip>
        <telephone>+98 21 2264 4701</telephone>
        <email>Sadeghi@avicenna.ac.ir S.Zafardoost@avicenna.ac.ir</email>
        <affiliation>Infertility and recurrent abortion treatment center of Avicenna</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1)Couples that undergoing treatment whit own gametes&#13;
2)women under 40 ears old&#13;
3)Women whit at least 4 good quality embryo after thawing(grade A)&#13;
4)Women that did not have more than 1 previous embryo transfer&#13;
Exclusion criteria:&#13;
1)Cycles whit no PGD(Preimplantation genetic diagnosis)&#13;
2)Women whit no uterine  anatomic disorder  or hydrosalpinx</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z31.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>In vitro fertilization</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group , embryos after thawing will cultured in medium with growth factor and in control group they will cultured in medium without growth factor. IN two groups will evaluate Blastocyst development and embryo quality.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Development of embryos to blastocysts. Timepoint: 5 days after intervention. Method of measurement: Microscopic evaluation of embryos.</prim_outcome>
      <prim_outcome>Implantation rate. Timepoint: 5 weeks after intervention. Method of measurement: Vaginal ultrasonography.</prim_outcome>
      <prim_outcome>Clinical pregnancy rate. Timepoint: 6 weeks after intervention. Method of measurement: Vaginal ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of embryos. Timepoint: 5 days after intervention. Method of measurement: Microscopic evaluation of embryos.</sec_outcome>
      <sec_outcome>Beta HCG level. Timepoint: 19 days after intervention. Method of measurement: Blood sample evaluation.</sec_outcome>
      <sec_outcome>Evaluation of abortion under 12 weeks. Timepoint: 12 weeks after intervention. Method of measurement: History of patient.</sec_outcome>
      <sec_outcome>Multiple pregnancy. Timepoint: 5 weeks after intervention. Method of measurement: Vaginal ultrasonography.</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>Infertility and recurrent abortion treatment center of Avicenna</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-14</approval_date>
        <contact_name>Research center of Avicenna</contact_name>
        <contact_address>97 no.Yakhchal street, Shariati Street. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
