<?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>IRCT2016090728950N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-26</date_registration>
      <primary_sponsor>Shahid Sadoughi University of Medical Sciences, Vice chancellor for research</primary_sponsor>
      <public_title>Intrauterine infusion of autologous  platelet rich plasma (PRP) on women with repeated frozen thawed cycles failure</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trail of comparison of pregnancy outcome in women with history of repeated implantation failure after intrauterine infusion of autologous platelet rich plasma (PRP) and women without intervention undergoing frozen thawed cycles</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23378</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized allocation with computerized program we divide the patients randomly in intervention and control groups with table of random numbers.</study_design>
      <phase>3</phase>
      <hc_freetext>female infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In 2nd day of cycle the patients undergo a basic trans vaginal sonography. For all the women who enter in frozen thawed cycles, estradiol tablet 2mg three times daily is initiated. In 13th day of cycle trans vaginal sonograghy is done for the patients again. Those who have endometrial thickness above 8mm enter in the study .They are divided in 2 groups randomly. In interventional group PRP (plasma riches platelet) is infused intrauterine with IUI catheter. Then Progesterone vaginal suppository 400 mg twice daily is prescribed for 3 days and embryos in cleavage state are transferred.                 . Intervention 2: Control group:  In 2nd day of cycle the patients undergo a basic trans vaginal sonography. For all the women who enter in frozen thawed cycles, estradiol tablet 2mg three times daily is initiated. In 13th day of cycle trans vaginal sonograghy is done for the patients again. Those who have endometrial thickness above 8mm enter in the study .They are divided in 2 groups randomly. In control group, they continue routine protocol and Progesterone vaginal suppository 400 mg twice daily is prescribed for 3 days then embryos in cleavage state are transferred.</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>Dr Nosrat Neghab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Avenue, Safayeh, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 1824 7085</telephone>
        <email>nosrat20@yahoo.com; nosratneghab@ssu.ac.ir</email>
        <affiliation>Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Maryam Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Avenue, Safayeh, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 1824 7085</telephone>
        <email>eftekharmaryam@yahoo.com</email>
        <affiliation>Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: women undergoing frozen thawed cycles; history of 2 or more history of implantation failure; age between 18 to 42&#13;
 exclusion criteria: hematological and immunological disorders; hormonal disorders; chromosomal and genetic abnormalities; uterine abnormalities (congenital or acquired)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>female infertility unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In 2nd day of cycle the patients undergo a basic trans vaginal sonography. For all the women who enter in frozen thawed cycles, estradiol tablet 2mg three times daily is initiated. In 13th day of cycle trans vaginal sonograghy is done for the patients again. Those who have endometrial thickness above 8mm enter in the study .They are divided in 2 groups randomly. In interventional group PRP (plasma riches platelet) is infused intrauterine with IUI catheter. Then Progesterone vaginal suppository 400 mg twice daily is prescribed for 3 days and embryos in cleavage state are transferred.                 .</i_keyword>
      <i_keyword>Control group:  In 2nd day of cycle the patients undergo a basic trans vaginal sonography. For all the women who enter in frozen thawed cycles, estradiol tablet 2mg three times daily is initiated. In 13th day of cycle trans vaginal sonograghy is done for the patients again. Those who have endometrial thickness above 8mm enter in the study .They are divided in 2 groups randomly. In control group, they continue routine protocol and Progesterone vaginal suppository 400 mg twice daily is prescribed for 3 days then embryos in cleavage state are transferred.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: serum pregnancy test.</prim_outcome>
      <prim_outcome>Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: trans vaginal sonograghy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shahid Sadoughi University of Medical Sciences, Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-22</approval_date>
        <contact_name>Ethics committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Bouali Avenue, Safayeh, Yazd, Iran Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
