<?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>IRCT201404065181N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-02</date_registration>
      <primary_sponsor>vhice chancellor of</primary_sponsor>
      <public_title>Comparison of using of recombinant Fsh long time    with or without hMG in IVf/ICSI cycles</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of using of recombinant Fsh long acting with or without hMG in IVf/ICSI cycles</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5557</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Female infertility associated with anovulation.</hc_freetext>
      <i_freetext>Intervention 1: Control group: A dose of 150 mcg corrifolitropin alfa received on the third day of the menstrual cycle , Antagonist drug Orgalutran, 5  mg is given on the seventh day.&#13;
 Then, during the monitoring cycle of seven days, if needed, will receive only the daily recombinant FSH. Ovarian response is followed by vaginal ultrasound, when at least one follicle greater than 18 mm and there were at least three follicles larger than 14-15 mm, HCG Pregnyl) will be injected with a dose of 10,000 units. Intervention 2: Intervention group: A dose of 150 mcg corrifolitropin alfa is administrated on the third day of the menstrual cycle. Antagonist drug Orgalutran, 5 mg  is given on the seventh day.&#13;
 Then on the seventh day after the cycle if needed, hMG will administrated. Ovarian response is followed by vaginal ultrasound, when at least one follicle greater than 18 mm and there were at least three follicles larger than 14-15 mm, HCG Pregnyl) will be injected with a dose of 10,000 units.</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,Batoolashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Immam Khomeini Hospital , vali-Asr Hospital,Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6658 1616</telephone>
        <email>bhrashidi@yahoo.com</email>
        <affiliation>Vali-e-Asr reproductive HealthnResearch center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr,Batool Rashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hospital,Vali-Asr Hospital, Keshavarz BlVd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6658 1616</telephone>
        <email>bhrashidi@yahoo.com</email>
        <affiliation>Vali-asr Reoroductive Health Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria:All patients agreed upon ESHRE Criteria 2011 ,advanced maternal age( &gt;40 years )؛ previous poor ovarian respond (POR)؛ abnormal ovarian reserve Test ( AFC=5-7, AMH=0.5-1.1)are enrolled. &#13;
&#13;
Exclusion Criteria:Cigaret user; history of ovarian cyst or surjeri in ovary;primary sensitivity to Cinal Or Gonal-F ; Tumors depended to Sex in reproductive systhem ;Adrenal failure or oncontrlod Thyroid;andometriosis;couple chromosomal difficulties;ovulatory dysfunction ( hypogonadic or hypergonadic infertility , hyperprolactinemia,thyroid disease, neoplastic ovary and adrenal,Kushing syndrome).</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 associated with anovulation</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>Control group: A dose of 150 mcg corrifolitropin alfa received on the third day of the menstrual cycle , Antagonist drug Orgalutran, 5  mg is given on the seventh day.&#13;
 Then, during the monitoring cycle of seven days, if needed, will receive only the daily recombinant FSH. Ovarian response is followed by vaginal ultrasound, when at least one follicle greater than 18 mm and there were at least three follicles larger than 14-15 mm, HCG Pregnyl) will be injected with a dose of 10,000 units.</i_keyword>
      <i_keyword>Intervention group: A dose of 150 mcg corrifolitropin alfa is administrated on the third day of the menstrual cycle. Antagonist drug Orgalutran, 5 mg  is given on the seventh day.&#13;
 Then on the seventh day after the cycle if needed, hMG will administrated. Ovarian response is followed by vaginal ultrasound, when at least one follicle greater than 18 mm and there were at least three follicles larger than 14-15 mm, HCG Pregnyl) will be injected with a dose of 10,000 units.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mature oocyte. Timepoint: time of getting  oocyte. Method of measurement: microscopic assay.</prim_outcome>
      <prim_outcome>Number of fetus. Timepoint: two  days after getting of oocytes. Method of measurement: microscopic assay by embryologists.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Days  of  ovulation induction. Timepoint: Medication at the time of ovulation induction. Method of measurement: Patient records.</sec_outcome>
      <sec_outcome>Abortion. Timepoint: two weeks after embryo transfer. Method of measurement: transvaginal sonography and blood test.</sec_outcome>
      <sec_outcome>Pregnancy. Timepoint: two weeks after embryo transfer. Method of measurement: transvaginal sonography and blood 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>vhice chancellor of</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-04-30</approval_date>
        <contact_name>Tehran University of Medical sciences ,Vice Chancellor for research</contact_name>
        <contact_address>Tehran University Building,Ghods Street,Keshavarz Blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
