<?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>IRCT20180417039338N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-18</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>effect of platelet-rich plasma(PRP)on fertility in women</public_title>
      <acronym></acronym>
      <scientific_title>Effect of platelet-rich plasma on clinical pregnancy outcome of women with recurrent implantation failure undergoing ART</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31489</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method was based on a random number table. By this method, the populations studied were numbered from 1 to N, then a table row and column are randomly selected. The point of intersection of the selected row and column is the start of sampling point. From this point, a cross is drawn. All numbers that appear on this cross will be selected as a sample.</study_design>
      <phase>2</phase>
      <hc_freetext>Noninflammatory disorder of female genital tract.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Continue estradiol since day 2 of cycle till end of study. Intervention 2: Intervention group:  Infusion of 0.5 cc of platelet rich plasma( PRP)that contained platelet 4-5 times more than peripheral blood with uterine catheter is performed if endometrial thickness below 6 mm on day 10 of cycle and the procedure is repeated 72 hours later if the endometrial thickness below 6mm.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is .</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Fatemeh Aghajanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>.</zip>
        <telephone>+98 11 3223 8284</telephone>
        <email>aghanjanzadeh@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sedigheh Esmaeilzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>.</zip>
        <telephone>+98 11 3223 8284</telephone>
        <email>sesmael@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy women between 18 and 40 years old
BMI below 30 kg / m 2
Have at least 3 or more unsuccessful fetal transmissions
Fetal removal candidate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Hemoglobin disorders (hemoglobin less than 11 mg / ml and platelet below 150,000)
Immunological disorders
Hormonal disorders of genetic and chromosomal anomalies
Acute infection
Uterus anomalies including the unicorn uterus (whether or not surgical) arcuate
History of uterine enzymes such as myomectomy and cesarean section
NSAID use within 10 days before intervention
Corticosteroid use over the past 1 month
Smoking
Fever
History of malignancy
Coagulation disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.9</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Continue estradiol since day 2 of cycle till end of study</i_keyword>
      <i_keyword>Intervention group:  Infusion of 0.5 cc of platelet rich plasma( PRP)that contained platelet 4-5 times more than peripheral blood with uterine catheter is performed if endometrial thickness below 6 mm on day 10 of cycle and the procedure is repeated 72 hours later if the endometrial thickness below 6mm.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fetal Vision Imaging. Timepoint: Week 5 after ET. Method of measurement: Vaginal ultrasound.</prim_outcome>
      <prim_outcome>Fetal heartburn. Timepoint: Week 5 after ET. Method of measurement: Vaginal ultrasound.</prim_outcome>
      <prim_outcome>Endometrial thickness. Timepoint: in 10th day of cycles and 72 hr after infusion of PRP. Method of measurement: Trans vaginal sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determine the amount of implantation. Timepoint: 4week after embryo transfer. Method of measurement: Trans vaginal sonography.</sec_outcome>
      <sec_outcome>Clinical pregnancy or miscarriage. Timepoint: 4week after embryo transfer. Method of measurement: Trans vaginal sonography.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-22</approval_date>
        <contact_name>Ethics Committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
