<?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>IRCT2017061434525N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-07</date_registration>
      <primary_sponsor>Iranian academic center for education culture and research</primary_sponsor>
      <public_title>Effect of autologous platelet-rich plasma on improving pregnancy outcomes in repeated implantation failure :A randomized controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>Effect of autologous platelet-rich plasma on improving pregnancy outcomes in repeated implantation failure: A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>118</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26361</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method is simple randomization and using the tool of sealed envelopes. Participants select one of the envelopes and deliver it to the relevant observer. The letters A and B are written inside the envelope and the participants are divided into two groups, Blinding description: Patients are unaware of the assignment to the groups. The examining physician and sonographer are unaware of the assignment of the patient to the groups. The analyzer is only aware of groups A and B and is not aware of the control and intervention group.</study_design>
      <phase>3</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: Injection of autologous platelet-rich plasma into the uterine cavity before embryos are transferred into the uterine cavity. Intervention 2: Control group: the standard procedure and without autologous platelet-rich plasma injection, the embryos are transferred into the uterine cavity.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is misuse</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Jafarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ACECR Infertility treatment center,Jame Jam AVE</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5163963173</zip>
        <telephone>+98 41 3329 5730</telephone>
        <email>sjafarzadeh@gmail.com</email>
        <affiliation>ACECR</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Elaheh Baybordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ACECR Infertility treatment center,Jaame jam Ave</address>
        <city>تبریز</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5163963173</zip>
        <telephone>+98 41 3337 5188</telephone>
        <email>baybordi@acecr.ac.ir</email>
        <affiliation>ACECR</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women of childbearing age (18-45 yrs)
A history of RIF (repeated implantation failure) during ART(Assisted reproductive technology ) treatments</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>pregnancy, 
Diagnosed cancers, 
Hemoglobin less than 11 gr per deciliter, 
Patelets less than 150,000/ cc, 
Use of anticoagulants, 
Use of Non-steroidal anti-inflammatory drugs up to 10 days before the procedure,
Any physical or mental illness that affects the patient's immunity and admission and disrupts the process of project implementation and patient follow-up.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complications of attempted introduction of embryo in embryo transfer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: Injection of autologous platelet-rich plasma into the uterine cavity before embryos are transferred into the uterine cavity</i_keyword>
      <i_keyword>Control group: the standard procedure and without autologous platelet-rich plasma injection, the embryos are transferred into the uterine cavity</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Positive pregnancy report with βHCG laboratory confirmed. Timepoint: 4 weeks after intervention. Method of measurement: Measurement of βHCG hormone (mg / dl) by the Laboratory.</prim_outcome>
      <prim_outcome>Check the pregnancy sac ,. Timepoint: 3 weeks after the check of positive HCG. Method of measurement: sonography.</prim_outcome>
      <prim_outcome>Check the fetus heart rate. Timepoint: 7 weeks after intervention. Method of measurement: sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ongoing Intrauterine pregnancy diagnosis. Timepoint: During pregnancy. Method of measurement: sonography.</sec_outcome>
      <sec_outcome>Ectopic pregnancy. Timepoint: During pregnancy. Method of measurement: sonography.</sec_outcome>
      <sec_outcome>Abortion. Timepoint: During pregnancy. Method of measurement: sonography.</sec_outcome>
      <sec_outcome>Live birth. Timepoint: end of pregnancy. Method of measurement: child birth.</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>Iranian academic center for education culture and research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-15</approval_date>
        <contact_name>Ethics Committee in Research Institute of Royanَ ,   ACECR</contact_name>
        <contact_address>Hafez Alley,North Bani Hashem ST,Resalat High Way Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
