<?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>IRCT2017073034422N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-16</date_registration>
      <primary_sponsor>Avicenna Research Institute</primary_sponsor>
      <public_title>Effects of  Autologus Platelet- Rich  Plasma on  ICSI outcomes  and  Pregnancy Rate in frozen embryo transfer cycles in Repeated Implantation Failure Patients</public_title>
      <acronym>PRP in RIF in FET cycles</acronym>
      <scientific_title>Effects of  Autologus Platelet- Rich  Plasma on  ICSI outcomes  and  Pregnancy Rate in frozen embryo transfer cycles in Repeated Implantation Failure Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26299</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, recurrent implantation failure.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group, PRP will be done for patient 48 hours before embryo transfer. For PRP, 8.5 cc of peripheral blood will be given and the number of platelet will be checked. Then the blood will be put in a space which &#13;
has 2.5 cc special anti coagulant and centrifuged with 1200 rpm for 12 minutes. Then superior part of plasma will be separated and centrifuged with  3500 rpm for 6 minutes again. The platelet number will be checked again and if it becomes 4-5 times, 0.5 cc of this solution will be transferred into uterus cavity 48 hours before embryo transfer. Intervention 2: In control group, the embryo transfer catheter will be inserted for patient 48 hours before embryo transfer and will be removed without injection of anything.</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>Sheyda Jouhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.97, Yakhchal St., Shariati St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19615-1177</zip>
        <telephone>+98 21 23519</telephone>
        <email>s.jouhari@ari.ir&#13;
info@avic.ir</email>
        <affiliation>Avicenna Infertility Clinic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sheyda Jouhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.97, Yyakhchal st. Shariati st.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19615-1177</zip>
        <telephone>+98 21 23519</telephone>
        <email>s.jouhari@ari.ir &#13;
info@avic.ir</email>
        <affiliation>Avicenna Infertility Clinic</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patient  who has at least 2 cycle IVF failure; At least 6 good quality embryos were transferred in previous cycles; Semen count≥10 millions,normal morphology  ≥3% in semen analysis&#13;
Exclusion criteria:&#13;
1-patient without immunologic disorders (abnormality in CD markers, Anti TG, Anti TPO, ds DNA, ANA); hematologic disorder; genetic diseases; uterus disorders; Hb&lt;11 mg/dl and Platelet&lt;150000/mm3; use of corticosteroid during 14 days before of PRP</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>41 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>98.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complication associated with artificial fertilization, unspecified</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>In intervention group, PRP will be done for patient 48 hours before embryo transfer. For PRP, 8.5 cc of peripheral blood will be given and the number of platelet will be checked. Then the blood will be put in a space which &#13;
has 2.5 cc special anti coagulant and centrifuged with 1200 rpm for 12 minutes. Then superior part of plasma will be separated and centrifuged with  3500 rpm for 6 minutes again. The platelet number will be checked again and if it becomes 4-5 times, 0.5 cc of this solution will be transferred into uterus cavity 48 hours before embryo transfer.</i_keyword>
      <i_keyword>In control group, the embryo transfer catheter will be inserted for patient 48 hours before embryo transfer and will be removed without injection of anything.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical pregnancy rate. Timepoint: Two weeks after intervention. Method of measurement: Beta HCG in blood.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Implantation Rate. Timepoint: Six weeks after intervention. Method of measurement: Calculation (number of embryos transfer /number of pregnancy sacs in sonography 6 weeks after ET).</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>Avicenna Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-02</approval_date>
        <contact_name>Avicenna Research Institute</contact_name>
        <contact_address>Avicenna Research Institute; Shahid Beheshti University; Velenjak; Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
