<?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>IRCT2016090328950N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-10</date_registration>
      <primary_sponsor>Shahid Sadoughi University of Medical Sciences, Vice chancellor for research</primary_sponsor>
      <public_title>Evaluation of intrauterine infusion of autologous  platelet rich plasma (PRP) on in vitro fertilization (IVF)</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of pregnancy outcome  in women with thin endometrium  after intrauterine infusion of autologous  platelet rich plasma (PRP) in comparison with  women with thin endometrium 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/23377</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized with table of random numbers with computerized software.</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 below 7mm enter in the study. PRP is infused intrauterine with IUI (intra uterine insemination) catheter. Endometrial thickness is measured after 48 hours. If endometrial thickness doesn't reach 7mm or above, the second dose of PRP will infuse. After 48 hours the endometrial thickness is measured and for whom with endometrial thickness above 7mm vaginal suppository Progesterone400 mg twice daily is prescribed for 3 days then 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 below 7mm enter in the study. They are divided in 2 groups randomly. In control group estradiol is continued for another 3 days .When endometrial thickness reaches 7mm or above, vaginal suppository Progesterone400 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>nosratneghab@ssu.ac.ir; nosrat20@yahoo.com</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; endometrial thickness less than 7 mm in 13 th day of cycle; age between 18 to 42&#13;
Exclusion criteria: hematological  and  immunological  disorders; &#13;
hormonal disorders; chromosomal and genetic abnormalities; uterine     abnormalities     &#13;
(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 below 7mm enter in the study. PRP is infused intrauterine with IUI (intra uterine insemination) catheter. Endometrial thickness is measured after 48 hours. If endometrial thickness doesn't reach 7mm or above, the second dose of PRP will infuse. After 48 hours the endometrial thickness is measured and for whom with endometrial thickness above 7mm vaginal suppository Progesterone400 mg twice daily is prescribed for 3 days then 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 below 7mm enter in the study. They are divided in 2 groups randomly. In control group estradiol is continued for another 3 days .When endometrial thickness reaches 7mm or above, vaginal suppository Progesterone400 mg twice daily is prescribed for 3 days then embryos in cleavage state are transferred .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endometrial thickness. Timepoint: 13th, 15th day of menstural cycle and in some patients 17th day of cycle. Method of measurement: trans vaginal sonograghy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: serum pregnancy test.</sec_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: trans vaginal sonograghy.</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 Yazd 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>
