<?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>IRCT2013012211430N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-04-17</date_registration>
      <primary_sponsor>Reaserch center of Avicenna</primary_sponsor>
      <public_title>Treatment of patients with recurrent pregnancy loss</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Granulocyte  Colony Stimulating Factor(G-CF) on treatment of unexplained recurrent miscarriage in Avicena center</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11702</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Recurrent pregnancy loss.</hc_freetext>
      <i_freetext>Intervention 1: Intra uterin infusion of G-CSF when follicle size is appropriate and 1 week after HCG. Intervention 2: Routin care; we have no intervention in control group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>  Objective&lt;br /&gt;&#13;
Endometrium undergoes several changes in structure and cellular compose during pregnancy. GCS-F (Granulocyte Colony-stimulating Factor) is an important cytokine with critical role in embryo implantation and pregnancy. The previous studies showed that that transvaginal endometrial perfusion with G-CSF might be helpful for improvement of implantation rate among patients with thin endometrium and repeated implantation failure (RIF). The aim of present study was to evaluate the impact of intrauterine injection of G-CSF in patients that suffering from unexplained recurrent miscarriage (RM). &lt;br /&gt;&#13;
Materials and Methods&lt;br /&gt;&#13;
In present randomized clinical trial a total of 68 patients were randomly allocated into two study groups including intrauterine G-CSF(300μg, Filgrastim, Switzerland) injection and control group (no G-CSF injection).All patients were in I/O (Ovulation Induction) cycle. In G-CSF group, intrauterine injection of G-CSF was done twice in cycle. All enrolled patients were under 40 years old and had at least two times unexplained pregnancy loss. Pregnancy was evaluated by titer of βhCG, presence of gestational sac (implantation) was assessed by vaginal ultrasonography and finally clinical pregnancy was confirmed by detection of fetal heart rate (FHR).&lt;br /&gt;&#13;
Results&lt;br /&gt;&#13;
Eighteen out of 68 patients were excluded from the final analysis due to different reasons. No significant difference were observed between two study groups when we compared the rate of chemical pregnancy (26.1% vs. 29.6%, P=1.000), implantation (26.1% vs. 22.2%, Fisher’s exact test P=0.673), clinical pregnancy (17.4% vs. 11.1%, Fisher’s exact test P: 0.657) and abortion (8.7% vs. 18.5% Fisher’s exact test P=0.921). &lt;br /&gt;&#13;
Conclusion&lt;br /&gt;&#13;
In contrast to possible effect of G-CSF on improvement of implantation rate that revealed by some other studies, based on the result of present study we couldn’t suggest intrauterine injection of G-CSF for improvement of clinical pregnancy rate and reduce of abortion among patients with unexplained RM. Further molecular biology studies are needed to clarify the mechanism in which G-CSF affects the pregnancy process. &lt;br /&gt;&#13;
         </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 Zafardoost Simin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati-Yakhchal</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19419113194</zip>
        <telephone>+98 21 2264 4701</telephone>
        <email>siminzafardoost@yahoo.com; S.Zafardoost@avicenna.ac.ir</email>
        <affiliation>Infertility and recurrent pregnancy loss center of Avicenna</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zafardoost Simin M.D</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati-Yakhchal</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19419113194</zip>
        <telephone>+98 21 2264 4701</telephone>
        <email>siminzafardoost@yahoo.com; S.Zafardoost@avicenna.ac.ir</email>
        <affiliation>Research Center of Jahad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with 3 or more abortion or 2 consecutive abortion; under 40 years old; normal karyotype; normal uterus; without infectious or immunologic or endocrine or thrombotic disorders; normal thyroid function,TPO&lt;=500; FSH&lt;=10; LH=normal and FBS=normal.&#13;
Exclusion criteria: cancer and no acceptance to participate in the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N96</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Habitual aborter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intra uterin infusion of G-CSF when follicle size is appropriate and 1 week after HCG</i_keyword>
      <i_keyword>Routin care; we have no intervention in control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abortion rate. Timepoint: 14 days after intervention- 3 months after intervention and 9 months after intervention. Method of measurement: Laboratory-ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Natural Killer cells. Timepoint: 14 days after HCG. Method of measurement: Measurment of CD16-CD56.</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>Reaserch center of Avicenna</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Jahad center of university</contact_name>
        <contact_address>Shahid Beheshty university Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
