<?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>IRCT201408021760N36</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-17</date_registration>
      <primary_sponsor>Vice chancellor for research,Babol University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of pregnancy rate in artificial and stimulation cycles with natural cycle in women candidate vitrified</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of pregnancy rate in artificial and stimulation cycles with natural cycle in women candidate vitrified</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1300</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>In vitro fertilization.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 2:  &#13;
  In the second intervention experimental group (Artificial), from the third day of the cycle, Estradiol vale-rate tablets 6 mg is given per day. When the endometrial thickness is greater than 8 mm, the shape and thickness of the endometrium is noted. From this special day, 100 mg injection of progesterone along with Estradiol is given daily. Five days after starting progesterone, blastocyst is transferred. If the endometrial thickness doesn't get to more than 8 mm in 15th day, Estradiol dose will be increased to 8 mg. In this method, the progesterone as a support would be continued till clarifying the pregnancy test in consistency with getting positive of pregnancy test until sixth week to eighth one of pregnancy. Intervention 2: Intervention Group 1: &#13;
In the first intervention experimental group (Stimulation), patients are taken Clomiphene Citrate tablets 100 mg daily from the fifth day to the ninth day of the cycle. &#13;
While follicles reach to 18-20 mm, shape and thickness of the endometrium are noted. After 36-38 hours, ovulation is confirmed by vaginal ultrasound, and blastocyst is transferred in 4 days. Intervention 3: Control Group:  &#13;
No drug is given for the control group (natural). &#13;
While follicles reach to 18-20 mm, shape and thickness of the endometrium are noted. After 36-38 hours, ovulation is confirmed by vaginal ultrasound and in 4 days blastocyst is 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>Fr. Otoufeh Sheikhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh-zahra Infertility and Reproductive Health Research Center, Old Road, Amol- Babol, After Mohammad Hassan Khan Bridge</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3227 4881</telephone>
        <email>Drsheikhi58@gmail.com</email>
        <affiliation>Fatemehzahra Infertility &amp; reproductive Health Reseach Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seddigheh Esmaeilzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh-zahra Infertility and Reproductive Health Research Center, Old Road, Amol- Babol, After Mohammad Hassan Khan Bridge</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3227 4881</telephone>
        <email>sesmael@yahoo.com</email>
        <affiliation>Fatemehzahra Infertility &amp; reproductive Health Reseach Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
All healthy women 18 to 40 years with a BMI = 20-32&#13;
        Exclusion criteria:&#13;
  Women with PCOs; untreated thyroid disorders; Severe Endometriosis; Patients with one ovarian or uterine and ovarian pathology; FSH more than 15 IU / LI on day 3 of the cycle; Poor Response; Smokers; Abnormalities of the uterus; &#13;
  Patients with diet changes and medication from 2 months ago; Professional Athletes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z31.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>In vitro fertilization</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 2:  &#13;
  In the second intervention experimental group (Artificial), from the third day of the cycle, Estradiol vale-rate tablets 6 mg is given per day. When the endometrial thickness is greater than 8 mm, the shape and thickness of the endometrium is noted. From this special day, 100 mg injection of progesterone along with Estradiol is given daily. Five days after starting progesterone, blastocyst is transferred. If the endometrial thickness doesn't get to more than 8 mm in 15th day, Estradiol dose will be increased to 8 mg. In this method, the progesterone as a support would be continued till clarifying the pregnancy test in consistency with getting positive of pregnancy test until sixth week to eighth one of pregnancy</i_keyword>
      <i_keyword>Intervention Group 1: &#13;
In the first intervention experimental group (Stimulation), patients are taken Clomiphene Citrate tablets 100 mg daily from the fifth day to the ninth day of the cycle. &#13;
While follicles reach to 18-20 mm, shape and thickness of the endometrium are noted. After 36-38 hours, ovulation is confirmed by vaginal ultrasound, and blastocyst is transferred in 4 days.</i_keyword>
      <i_keyword>Control Group:  &#13;
No drug is given for the control group (natural). &#13;
While follicles reach to 18-20 mm, shape and thickness of the endometrium are noted. After 36-38 hours, ovulation is confirmed by vaginal ultrasound and in 4 days blastocyst is transferred.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy. Timepoint: Sixth week until the eighth week after embryo transfer. Method of measurement: SONO - Vaginal.</prim_outcome>
      <prim_outcome>The number of abortions performed. Timepoint: After 10 weeks of gestational sac formation. Method of measurement: clinical.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Form Endometrium. Timepoint: Day of HCG injection. Method of measurement: SONO - Vaginal.</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,Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-09</approval_date>
        <contact_name>The ethics committee of Babol University of Medical sciences</contact_name>
        <contact_address>Ganjafroz Avenue, Babol University of Medical sciences Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
