<?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>IRCT2012071910328N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-11-14</date_registration>
      <primary_sponsor>Wise Canceler of  Shahid Sadoughi University of Medical Sciences of Yazd,Research and Clinical Cente</primary_sponsor>
      <public_title>Comparison of two protocol of endometrial preparation  in thawed- embryo transfer  cycles</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effect of transdermal  estradiol  and estradiol valerate on endometrial receptivity in frozen-thawed embryo transfer cycles</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10838</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: In  intervention  group (45 patients),at the same time of menses will applied 17-B estradiol transdermal patches 100 mcg  every other day  that each patch will removed after four days .In both group clinical monitoring by transvaginal ultrasound will done on 11th day of menstruation to measure endometrial thickness. While endometrial thickness is less than  7.5 mm, will increased dose of17-B estradiol transdermal patches to 200 mcg daily .After 3 day will repeated monitoring  and while endometrial thickness are more than or equal 7.5 , 100 mg progesterone in oil daily IM injection will be done. After 48-72 hours, between 1-3 embryo will transferred  trans-cervically. Hormonal therapy will continued till pregnancy test after 2 weeks. While pregnancy test is positive , 2-3 weeks after, sonography for observation of the fetal heart activity will done. If pregnancy document with sonography , hormonal therapy continue till 10th weeks of pregnancy. Intervention 2: In  control group (45 patients), for endometrial preparation  will started from 2nd day of cycle oral estradiol 6 mg daily.  In both group clinical monitoring by transvaginal ultrasound will done on 11th day of menstruation to measure endometrial thickness. While endometrial thickness is less than  7.5 mm, will increased dose of oral estradiol to 2mg each 6 hours .After 3 day will repeated monitoring  and while endometrial thickness are more than or equal 7.5 , 100 mg progesterone in oil daily IM injection will be done. After 48-72 hours, between 1-3 embryo will transferred trans-cervically. Hormonal therapy  will continued till pregnancy test after 2 weeks. While pregnancy test is positive , 2-3 weeks after, sonography for observation of the fetal heart activity will done. If pregnancy document with sonography , hormonal therapy continue till 10th weeks of pregnancy.</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.Sima Janati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave, Safayeh،  Research and Clinical Center for Infertility, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1824 7085</telephone>
        <email>janati@dums.ac.ir</email>
        <affiliation>Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Robab Davar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave, Safayeh , Research and Clinical Center for Infertility, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 1824 7085</telephone>
        <email>r-davar@yahoo.com</email>
        <affiliation>Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: female  &#13;
 Exclusion criteria: FSH in day 3 of cycle more than 12 ; age below  20  and more than 40 years; bad qaulity vitrified/warmed embryo; polycystic ovarian syndrome ;  endocrine or metabolic   disorder;endometriosis ; egg donation</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>In  intervention  group (45 patients),at the same time of menses will applied 17-B estradiol transdermal patches 100 mcg  every other day  that each patch will removed after four days .In both group clinical monitoring by transvaginal ultrasound will done on 11th day of menstruation to measure endometrial thickness. While endometrial thickness is less than  7.5 mm, will increased dose of17-B estradiol transdermal patches to 200 mcg daily .After 3 day will repeated monitoring  and while endometrial thickness are more than or equal 7.5 , 100 mg progesterone in oil daily IM injection will be done. After 48-72 hours, between 1-3 embryo will transferred  trans-cervically. Hormonal therapy will continued till pregnancy test after 2 weeks. While pregnancy test is positive , 2-3 weeks after, sonography for observation of the fetal heart activity will done. If pregnancy document with sonography , hormonal therapy continue till 10th weeks of pregnancy.</i_keyword>
      <i_keyword>In  control group (45 patients), for endometrial preparation  will started from 2nd day of cycle oral estradiol 6 mg daily.  In both group clinical monitoring by transvaginal ultrasound will done on 11th day of menstruation to measure endometrial thickness. While endometrial thickness is less than  7.5 mm, will increased dose of oral estradiol to 2mg each 6 hours .After 3 day will repeated monitoring  and while endometrial thickness are more than or equal 7.5 , 100 mg progesterone in oil daily IM injection will be done. After 48-72 hours, between 1-3 embryo will transferred trans-cervically. Hormonal therapy  will continued till pregnancy test after 2 weeks. While pregnancy test is positive , 2-3 weeks after, sonography for observation of the fetal heart activity will done. If pregnancy document with sonography , hormonal therapy continue till 10th weeks of pregnancy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endometrial thickness. Timepoint: 10-20 days. Method of measurement: Measurement  between two layers of endometrium by  vaginal sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 4-5 weeks after embryo transfer. Method of measurement: Observation of fetal heart activity by transvaginal sonography.</sec_outcome>
      <sec_outcome>Time of endometrial preparation. Timepoint: 11-14 days. Method of measurement: Repeated vaginal sonography.</sec_outcome>
      <sec_outcome>Cancelation rate of cycles. Timepoint: 10-20 days. Method of measurement: Repeated vaginal sonography.</sec_outcome>
      <sec_outcome>Chemical pregnancy. Timepoint: Two weeks after embryo transfer. Method of measurement: BHCG test.</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>Wise Canceler of  Shahid Sadoughi University of Medical Sciences of Yazd,Research and Clinical Cente</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-03-15</approval_date>
        <contact_name>Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd,Ir</contact_name>
        <contact_address>Bouali Ave, Safayeh, Research and Clinical Center for Infertility, Yazd Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
