<?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>IRCT20160722029027N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-04</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of platelet rich plasma (PRP) improving pregnancy outcome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of platelet rich plasma (PRP) on improving pregnancy outcome in recurrent pregnancy loss patients a randomized clinical trial pilot study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41765</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by generating random numbers in Excel software.
1. In a column of Excel we enter 25 samples in each group.
2. In the next column we generate random numbers using the following command: RAND ()
3. After sorting the generated random numbers, a random list will be generated according to which people will be assigned to two groups, Blinding description: Blindness will be such that the patient will not know what treatment she will receive. Also, the researcher who records the results will not be aware of the type of treatment applied to the patient.</study_design>
      <phase>2</phase>
      <hc_freetext>Noninflammatory disorders of female genital tract.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Initiation of ovarian stimulation will start on day 3 of the menstrual cycle. Follicular monitoring will perform using serial ultrasonography. When the diameter of follicles reached approximately 14 mm, the GnRH antagonist will start. When at least three follicles &gt;17 mm diameter visualizes in the ovaries, ovulation trigger will carry out using 10000 IU of human chorionic gonadotropin (hCG). The oocytes will aspirate from the ovaries 36 hours later. After intra-cytoplasmic sperm injection, intrauterine administration of platelet rich plasma (PRP) will be performed 48 hours before embryo transfer. Autologous PRP will be prepared during  the 2-step procedure. Prepared PRP (5 CC) will be inoculated into the uterus. Finally, blastocyst embryos will transfer to the uterus. Intervention 2: Control group:  Initiation of ovarian stimulation will start on day 3 of the menstrual cycle. Follicular monitoring will perform using serial ultrasonography. When the diameter of follicles reached approximately 14 mm, the GnRH antagonist will start. When at least three follicles &gt;17 mm diameter visualizes in the ovaries, ovulation trigger will carry out using 10000 IU of human chorionic gonadotropin (hCG). The oocytes will aspirate from the ovaries 36 hours later. After intra-cytoplasmic sperm injection, blastocyst embryos will transfer to the uterus.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only information about the main outcome can be shared.

When:
Without restriction

To whom:
All researchers

Conditions:
With permission from the responsible author

Where to obtain:
Email to the responsible author

How to obtain:
Email to the responsible author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Teibeh Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shabih Khani Hospital .Shahid Beheshti St</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8714715555</zip>
        <telephone>+98 31 5546 0180</telephone>
        <email>hashemit89@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani hospital, Yaman st., Velenjak, Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2243 2558</telephone>
        <email>nazari@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women under 40 years
30&gt;BMI
At least two pregnancy loss</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Immunologic disorder
Anti phospholipid syndrome
Hormonal disturbance
Chromosomal disorder
Congenital and acquired uterine disorder
Hematological  disturbance</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Initiation of ovarian stimulation will start on day 3 of the menstrual cycle. Follicular monitoring will perform using serial ultrasonography. When the diameter of follicles reached approximately 14 mm, the GnRH antagonist will start. When at least three follicles &gt;17 mm diameter visualizes in the ovaries, ovulation trigger will carry out using 10000 IU of human chorionic gonadotropin (hCG). The oocytes will aspirate from the ovaries 36 hours later. After intra-cytoplasmic sperm injection, intrauterine administration of platelet rich plasma (PRP) will be performed 48 hours before embryo transfer. Autologous PRP will be prepared during  the 2-step procedure. Prepared PRP (5 CC) will be inoculated into the uterus. Finally, blastocyst embryos will transfer to the uterus.</i_keyword>
      <i_keyword>Control group:  Initiation of ovarian stimulation will start on day 3 of the menstrual cycle. Follicular monitoring will perform using serial ultrasonography. When the diameter of follicles reached approximately 14 mm, the GnRH antagonist will start. When at least three follicles &gt;17 mm diameter visualizes in the ovaries, ovulation trigger will carry out using 10000 IU of human chorionic gonadotropin (hCG). The oocytes will aspirate from the ovaries 36 hours later. After intra-cytoplasmic sperm injection, blastocyst embryos will transfer to the uterus.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical pregnancy. Timepoint: 5-7 weeks of gestation. Method of measurement: Ultrasonography.</prim_outcome>
      <prim_outcome>Ongoing pregnancy. Timepoint: 20 weeks of gestation. Method of measurement: Ultrasonography.</prim_outcome>
      <prim_outcome>Live birth. Timepoint: 9 months after embryo transfer. Method of measurement: Visualization.</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 Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-01</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Velenjak, Yaman St, Chamran highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
