<?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>IRCT201306256689N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-31</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing two protocols for endometrial preparation  for frozen  embryo  transfer</public_title>
      <acronym></acronym>
      <scientific_title>Comparing pregnancy rate in GnRH agonist and letrozole plus gonadotropins  protocol for endometrial preparation  for frozen  embryo  transfer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-08-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7100</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: All patients sign informed consents forms. The sample included 100 patients who are divided in two groups randomly based in Bernoli distribution.</study_design>
      <phase>2</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: First group receives GnRH Agonist (Bucerelin, Aventis, Germany) 500 μg subcutaneously from previous midluteal cycle (21th day). Then Estradiol valerat (Daroopakhsh, Iran, 2 mg) daily oral is started on second day and is increased until the observation of 8mm endometrial thickness in transvaginal ultrasound. For visualizing endometrial thickness, Trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 4 days. After the observation of at least 8mm endometrial thickness, Progesterone (Cyclogest, Germany, 800 mg) is started vaginally. After 3 days, Trans cervical embryo transfer will be carried out on day 16 to 19. Intervention 2: Second group, receives letrozole (Iranhormone, Iran, 5mg daily) orally on 2th day of cycle for five days. Then HMG (Ferring, Germany, 75IU daily) is started on 7 day. After the observation of 18mm follicle in transvaginal ultrasound, HCG (Ferring, Germany, 10000IU, and IM) is injected for ovulation induction. Trans cervical embryo transfer is performed on day 16 to 19.</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 Sedighe Hoseinimosa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Infertility Department, Shariati Hospital, North Karegar Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8800 8810</telephone>
        <email>hoseinimosa@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences, Shariati Hospital, Department of Infertility</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Professor Ashraf Aleyasin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Infertility Department, Shariati Hospital, North Karegar Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8800 8810</telephone>
        <email>Aleyasin@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Infertile women 18-42 years old with freeze embryo&#13;
 Exclusion Criteria: &#13;
 1- Male infertility which needs interventions such as TESE (Testicular Sperm Extraction)  or  PESA (Percutaneous Epididymal Sperm Aspiration)&#13;
 2- Endometriosis (stage 3 or 4) &#13;
 3- Uterine myoma with 4cm size or greater&#13;
 4- Maternal age greater than 42 years old&#13;
 5- Fresh embryo</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility associated with male factors</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>First group receives GnRH Agonist (Bucerelin, Aventis, Germany) 500 μg subcutaneously from previous midluteal cycle (21th day). Then Estradiol valerat (Daroopakhsh, Iran, 2 mg) daily oral is started on second day and is increased until the observation of 8mm endometrial thickness in transvaginal ultrasound. For visualizing endometrial thickness, Trans vaginal ultrasound (Sonoline G20; Siemens Medical Solutions, California, USA) is performed every 4 days. After the observation of at least 8mm endometrial thickness, Progesterone (Cyclogest, Germany, 800 mg) is started vaginally. After 3 days, Trans cervical embryo transfer will be carried out on day 16 to 19.</i_keyword>
      <i_keyword>Second group, receives letrozole (Iranhormone, Iran, 5mg daily) orally on 2th day of cycle for five days. Then HMG (Ferring, Germany, 75IU daily) is started on 7 day. After the observation of 18mm follicle in transvaginal ultrasound, HCG (Ferring, Germany, 10000IU, and IM) is injected for ovulation induction. Trans cervical embryo transfer is performed on day 16 to 19.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical Pregnancy. Timepoint: 16 days after embryonal transfer. Method of measurement: βhCG titration.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 30 days after embryonal transfer. Method of measurement: Observed gestational sac in transvaginal sonography.</sec_outcome>
      <sec_outcome>Implantation Rate. Timepoint: 30 days after embryonal transfer. Method of measurement: The number of observed gestational sac in transvaginal sonography / the number of transferred embryos * 100.</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>Vice Chancellor for Research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-05-22</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
