<?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>IRCT2014120210617N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-15</date_registration>
      <primary_sponsor>Hamadan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Fennel on endometrial thickness</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Trial of the Effect of Fennel and Estrogen Compared with Estrogen Alone on Duration of Endometrial Thickness to Reach 8 millimeters in Women with Indication for Fetus Donation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11081</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>female infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients will receive low dose tablet of oral contraceptive from the third day of menstrual cycle until the 21st day. Then from day 14 to 28 one ampule of gonadotropin releasing hormone (Buserelin) 0.5 milliliter will be administered subcutaneously daily. On the day 28 patients will receive oral tablets of estradiol valerate 6 milligrams/day and fennel as herbal tea, made with 10 grams of fennel boiled with 50 milliliter water for 20 minutes. On the 30th day and then every 3 days transvaginal ultrasound will be done to measure endometrial thickness. During this period 0.2 milliliter Buserelin will be continued subcutaneously. Intervention 2: Control group: patients will receive low dose tablet of oral contraceptive from the third day of menstrual cycle until the 21st day. Then from day 14 to 28 one ampule of gonadotropin releasing hormone (Buserelin) 0.5 milliliter will be administered subcutaneously daily. On the day 28 patients will receive oral tablets of estradiol valerate 6 milligrams/day (without fennel). On the 30th day and then every 3 days transvaginal ultrasound will be done to measure endometrial thickness. During this period 0.2 milliliter Buserelin will be continued subcutaneously.</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>Sarah Nazari Valashedjerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite Mardom Park, Shahid Fahmideh St, Pajouhesh Sq, Daneshgah Blvd</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 1827 7459</telephone>
        <email>drsara_nazari@yahoo.com</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Yavangui</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Opposite Mardom Park, Shahid Fahmideh St, Pajouhesh Sq, Daneshgah Blvd</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 1827 7459</telephone>
        <email>yavangi@umsha.ac.ir</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: all women with indication for fetus donation; giving written consent to inclusion&#13;
Exclusion criteria: none</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>51 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</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: patients will receive low dose tablet of oral contraceptive from the third day of menstrual cycle until the 21st day. Then from day 14 to 28 one ampule of gonadotropin releasing hormone (Buserelin) 0.5 milliliter will be administered subcutaneously daily. On the day 28 patients will receive oral tablets of estradiol valerate 6 milligrams/day and fennel as herbal tea, made with 10 grams of fennel boiled with 50 milliliter water for 20 minutes. On the 30th day and then every 3 days transvaginal ultrasound will be done to measure endometrial thickness. During this period 0.2 milliliter Buserelin will be continued subcutaneously.</i_keyword>
      <i_keyword>Control group: patients will receive low dose tablet of oral contraceptive from the third day of menstrual cycle until the 21st day. Then from day 14 to 28 one ampule of gonadotropin releasing hormone (Buserelin) 0.5 milliliter will be administered subcutaneously daily. On the day 28 patients will receive oral tablets of estradiol valerate 6 milligrams/day (without fennel). On the 30th day and then every 3 days transvaginal ultrasound will be done to measure endometrial thickness. During this period 0.2 milliliter Buserelin will be continued subcutaneously.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The time for endometrium to reach 8 millimetes in thickness. Timepoint: 30th day of menstrual cycle and then every 3 days until reaching 8 milliliters in thickness. Method of measurement: Counting days.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Endometrial thickness. Timepoint: Thirtieth day of menstural cycle and then every 3 days. Method of measurement: Transvaginal ultrasound.</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>Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-17</approval_date>
        <contact_name>Hamadan University of Medical Sciences</contact_name>
        <contact_address>Opposite Mardom Park, Shahid Fahmideh St, Pajouhesh Sq, Daneshgah Blvd Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
