<?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>IRCT2015060222541N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-24</date_registration>
      <primary_sponsor>Vice Chancellor of Research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing hormone profile and outcomes of ovulation triggering with GnRH and HGC in IVF</public_title>
      <acronym></acronym>
      <scientific_title>A prospective randomized clinical trial on mid-cycle triggering of final oocyte maturation using GnRH versus HCG in Antagonist protocol</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-02-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>232</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19427</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomisation will be implemented using table of random numbers.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Female infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In intervention group the patient will receive GnRh agonist (Decapeptyl; Ferring, The Netherlands), 0.2 mg sc for triggering final oocyte maturation. Intervention 2: Control group: In control group the patients will receive HCG 10000 IU sc (Institute Biochimique SA (IBSA), The Switzerland) for triggering final oocyte maturation.</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. leila Sarikhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>OB. &amp; GYN. Office, Shahid Faghihi Hospital, Zand Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3229 8396</telephone>
        <email>sarikhani_l@sums.ac.ir; dr.l.sarikhani@gmail.com</email>
        <affiliation>OB. &amp; GYN Department, Shiraz Medical School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ebrahim Parsanezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>OB. &amp; GYN. Department, Shahid Faghihi Hospital, Zand Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3233 2365</telephone>
        <email>parsame@rogers.ca; obgynward@sums.ac.ir</email>
        <affiliation>OB. &amp; GYN. Department, Shiraz Medical School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: All patients who are candidate for IVF/ICSI( Male factor infertility, unexplained infertility, tubal factor infertility), Age below 39 years old, BMI: 18-29, Regular menstrual cycles.Agreement of patient to enrol the research &#13;
&#13;
Exclusion criteria: Ovulatory factor infertility, Endometriosis, Uterine anomalies,  Age above 39 years old, Non-agreement of patient to enrol the research</inclusion_criteria>
      <agemin>24 years</agemin>
      <agemax>36 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</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: In intervention group the patient will receive GnRh agonist (Decapeptyl; Ferring, The Netherlands), 0.2 mg sc for triggering final oocyte maturation</i_keyword>
      <i_keyword>Control group: In control group the patients will receive HCG 10000 IU sc (Institute Biochimique SA (IBSA), The Switzerland) for triggering final oocyte maturation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number and Quality  of oocytes retrieved in each IVF cycle. Timepoint: on day of ovum pick up. Method of measurement: measuring number and quality of oocytes  on the day of pick up by pathologist in lab under microscope and scoring.</prim_outcome>
      <prim_outcome>Progesterone level. Timepoint: on the day of injection HCG or GnRH agonist(Final Triggering) and rechecked 7 and 14 days after that. Method of measurement: Serum Level, Lab test.</prim_outcome>
      <prim_outcome>Number and Quality of embryos transferred in IVF cycle. Timepoint: on day of embryo transfer. Method of measurement: measuring number and quality of embryos by pathologist in lab under microscope and grading.</prim_outcome>
      <prim_outcome>Comparing FSH, LH, Estradiol and HCG in both groups. Timepoint: on days 2 and 6 of menstrual cycle, final oocyte triggering, oocyte retrieval, 7 and 14 days after that oocyte retrieved. Method of measurement: Serum Level, Lab test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Rate of ovarian hyperstimulation syndrome (OHSS). Timepoint: From day of HCG or GnRH agonist injection up to 2 weeks later. Method of measurement: Clinical management of symptoms, Sonography.</sec_outcome>
      <sec_outcome>Clinical Pregnancy. Timepoint: 16 days after triggering if menstruation was absent. Method of measurement: Serum BHCG and TVS.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>90-01-01-3979</sec_id>
        <issuing_authority>Shiraz University of Medical Sciences</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor of Research, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-21</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Science</contact_name>
        <contact_address>Shiraz University of Medical Science , Zand street Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
