<?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>IRCT20160815029374N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-11</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>PRP in infertility</public_title>
      <acronym></acronym>
      <scientific_title>The effect of intrauterine infusion of platelet-rich plasma and number of infusion on increasing the thickness of endometrium and pregnancy rate in patients with thin endometrium.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29901</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done based on the random number table on the day of estrogen  initiation in freeze embryo transfer cycle by one nurse. In fact, only the nurse knows which patient is under the one or two PRP infusion. Physicians do not know which patient is undergoing one or two PRP, but patients know about the intervention due to informed consent,therefore, it is not possible to concealed the patients in this group.</study_design>
      <phase>2</phase>
      <hc_freetext>Diseases of the genitourinary system.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intrauterine infusion of 0.5 CC of autologus platelet-rich plasma (has 4-6 times platelet concentration rather than peripheral blood by IUI catheter(Takvin company, Iran) on day 11 of  freeze embryo transfer cycle. Intervention 2: Intervention group: Intrauterine infusion of 0.5 CC of autologus platelet-rich plasma (has 4-6 times platelet concentration rather than peripheral blood by IUI catheter(Takvin company, Iran) on day 13 of  freeze embryo transfer cycle. Intervention 3: Control group: Transfer of three Freeze embryos by chateter ( Cook, USA) under ultrasonographic guidance.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Zamaniyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, First floor, Infertility ward, Imam Khomeini Hospital, Amir Mazandarani Ave,</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>331314816</zip>
        <telephone>+98 11333661700</telephone>
        <email>marziehzamaniyan@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Zamaniyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, First floor, Infertility ward, Imam Khomeini Hospital, Amir Mazandarani Ave,</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3313148166</zip>
        <telephone>+98 11333661700</telephone>
        <email>marziehzamaniyan@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged between 20-40 years
BMI Between 20-30 kg/m2
Freez embryo transfer
Prior failed embryo transfer cycle due to thin endometrium
endometrial line below 7 on day 10 of cycle
without endometrial pathology on hystrosalpingography or hysteroscopy</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Abnormal uterine form conture on hystrosalpingography or hysteroscopy
Hematologic disease
Hormonal disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97; N98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility; Complications associated with artificial fertilization</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intrauterine infusion of 0.5 CC of autologus platelet-rich plasma (has 4-6 times platelet concentration rather than peripheral blood by IUI catheter(Takvin company, Iran) on day 11 of  freeze embryo transfer cycle.</i_keyword>
      <i_keyword>Intervention group: Intrauterine infusion of 0.5 CC of autologus platelet-rich plasma (has 4-6 times platelet concentration rather than peripheral blood by IUI catheter(Takvin company, Iran) on day 13 of  freeze embryo transfer cycle.</i_keyword>
      <i_keyword>Control group: Transfer of three Freeze embryos by chateter ( Cook, USA) under ultrasonographic guidance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Increase in endometrial thickness rate. Timepoint: 48 hours after intrauterine injections of platelet-rich plasma. Method of measurement: Ultrasound.</prim_outcome>
      <prim_outcome>Clinical pregnancy rate. Timepoint: Forth weeks after embryo transfer. Method of measurement: Ultrasound.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Miscarriage rates. Timepoint: Till twenty weeks after embryo transfer. Method of measurement: Questionnare.</sec_outcome>
      <sec_outcome>Chemical pregnancy rate. Timepoint: Two weeks after embryo transfer. Method of measurement: B-HCG Kit.</sec_outcome>
      <sec_outcome>Implantation rate. Timepoint: Forth weeks after embryo transfer. Method of measurement: Questionare.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-07</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>No. 5, third floor, Cancer ward, Imam Khomeini Hospital, Amir Mazandarani Ave, Diabetes Research Center. Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
