<?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>IRCT2017020520351N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-21</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of pretreatment of E2 and OCP in Antagonist cycle In  IVF cycles.</public_title>
      <acronym>OCP; E2; Antagonist</acronym>
      <scientific_title>Evaluation of the effect of pretreatment of E2 and OCP  before  Antagonist cycle on IVF outcome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>195</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18052</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Female infertility associated with anovulation.</hc_freetext>
      <i_freetext>Intervention 1: In group without intervention ( Control): only antagonist 25 miligram daily is administrated from the second day  of the cycle. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is  at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done. Intervention 2: In intervention group 1: daily treatment is a pill (OCP) for 10 days and 10-12 days before the last cycle. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is  at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done. Intervention 3: In intervention group 2: daily treatment is a Estradiol Pill  for 10 days and  before the start of Antagonist administration. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is  at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done.</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>Fatemeh Bakhtiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First floor, Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14194</zip>
        <telephone>+98 21 6658 1658</telephone>
        <email>bakhtiyari1355@gmail.com</email>
        <affiliation>Reproductive Health Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Sohrabvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First floor, Valiasr Hospital 2, Imam Khomeini Hospital, Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14194</zip>
        <telephone>+98 21 6658 1658</telephone>
        <email>fsohrabvand@yahoo.com</email>
        <affiliation>Reproductive Health Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: women with 20-35 years old; prior IVF less than 2; AFC&gt;4; FSH&lt;10; without any pathology in ovary or endometrioma more than 1cm; without any hydrosalpinx.&#13;
Exclusion criteria: PCOS; pathology in uterus or ovary ( myoma larger than 5 cm); absence of vaginal bleeding until 6 days after disconnection of OCP or E2; lack of permission of patients.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.0</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In group without intervention ( Control): only antagonist 25 miligram daily is administrated from the second day  of the cycle. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is  at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done.</i_keyword>
      <i_keyword>In intervention group 1: daily treatment is a pill (OCP) for 10 days and 10-12 days before the last cycle. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is  at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done.</i_keyword>
      <i_keyword>In intervention group 2: daily treatment is a Estradiol Pill  for 10 days and  before the start of Antagonist administration. In all three groups of patients after 6 days of treatment, vaginal ultrasound will be done every other day. When the follicles greater than 13 mm was observed, antagonist starts with 25 mg and when there is  at least three follicles greater than 17 mm, HCG 10000 unit is injected. After 36 hours, pick up the ovum will be done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oocyte number. Timepoint: Six days after treatment. Method of measurement: Vaginal sonography.</prim_outcome>
      <prim_outcome>Number of induction ovulation. Timepoint: After treatment. Method of measurement: Transvaginal sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: B-HCG Test.</sec_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: Three weeks after do positive of pregnancy teset. Method of measurement: Transvaginal sonography.</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>2010-09-23</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Central Building, Tehran University of Medical Sciences, Ghods Street, Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
