<?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>IRCT201205309910N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-24</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing two different drug methods for infertility treatment by assisted reproduction techniques (ARTs)</public_title>
      <acronym>GnRH</acronym>
      <scientific_title>Investigation of outcome of assessment reproduction treatment and prevention of ovarian hyper stimulation syndrome in GnRH agonist protocol compared to GnRH antagonist protocol</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-01-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>136</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10434</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention 1: Group A: a daily dose of Buserelin 500 µg given SC and commenced 21th day of cycle, and vaginal ultrasonography continued onward until estradiol on the 2nd day of cycle. Intervention 2: Group B: GnRH antagonist was administered. Ovarian stimulation was started on the 2nd day of the cycle by SC injection of 75 IU of FSH daily. On the 6th day of stimulation, 0.25 mg Cetrorelix was initiated. Based on the ovarian response detected by ultrasonography, gonadotropin dose was adjusted in both groups. Administration of Buserelin and Cetrorelix was continued until the time of HCG injection. When at least 3 follicles with a mean diameter of 18 mm were developed, HCG 10,000 IU was injected IM. At this stage, endometrial thickness was studied Trans vaginal ultrasonographically, and after 36 hours, oocyte retrieval was performed. After IVF or ICSI, Cyclogest 800 mg was prescribed daily to provide luteal phase support and continued till the activity of FHR was confirmed TVS.16days after the oocyte retrieval, serum HCG level was checked to determine chemical pregnancy. TVS  was carried out for clinical determination of pregnancy.</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>Setare Nasiri Zeydi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 911 255 6829</telephone>
        <email>setare_n99@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Setare Nasiri Zeydi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 911 255 6829</telephone>
        <email>setare_n99@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: undergoing assisted reproduction techniques (ARTs) for the first time, age ≤35years and serum FSH level ≤10 IU/liter.  Exclusion criteria: women with the previous history of IVF or ICSI; patients who had hyperprolactinemia, thyroid dysfunction, uterine abnormality, severe endometriosis and secondary infertility.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>35 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>Group A: a daily dose of Buserelin 500 µg given SC and commenced 21th day of cycle, and vaginal ultrasonography continued onward until estradiol on the 2nd day of cycle.</i_keyword>
      <i_keyword>Group B: GnRH antagonist was administered. Ovarian stimulation was started on the 2nd day of the cycle by SC injection of 75 IU of FSH daily. On the 6th day of stimulation, 0.25 mg Cetrorelix was initiated. Based on the ovarian response detected by ultrasonography, gonadotropin dose was adjusted in both groups. Administration of Buserelin and Cetrorelix was continued until the time of HCG injection. When at least 3 follicles with a mean diameter of 18 mm were developed, HCG 10,000 IU was injected IM. At this stage, endometrial thickness was studied Trans vaginal ultrasonographically, and after 36 hours, oocyte retrieval was performed. After IVF or ICSI, Cyclogest 800 mg was prescribed daily to provide luteal phase support and continued till the activity of FHR was confirmed TVS.16days after the oocyte retrieval, serum HCG level was checked to determine chemical pregnancy. TVS  was carried out for clinical determination of pregnancy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ovarian hyperstimulation syndrome. Timepoint: 10 days after HCG injection and during primary Trimester. Method of measurement: as presence of enlarged ovarian cysts more than 12 by 12 cm, ascites, pleural and/or pericardial effusion, electrolyte imbalance ,hypovolemia, and hypovolemic shock.</prim_outcome>
      <prim_outcome>Fertility. Timepoint: after primary Trimester. Method of measurement: ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of retrieved oocytes. Timepoint: 2 weeks after intervention. Method of measurement: number of retrieved oocytes in retrieval day.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-11-09</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar jerib street Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
