<?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>IRCT20110908007513N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-16</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>comparative study of three ovulation trigger methods in IVF/ICSI in poor response</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of double recombinant HCG injection and HCG injection (alone and in combination with GNRH) on the pregnancy outcome of patients with poor response in the ovulation stimulation cycle (IVF / ICSI)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62722</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To perform oocyte triggering, patients are randomly divided into three groups.
Due to the small sample size and to ensure the balance of the number of people in each group, we will use the restricted randomization method of block randomization and thus 15 out of 15 blocks including 2 Up to A, 2 to B and 2 to C will be formed, Blinding description: Patients who are eligible to enter the study are placed in one of three drug classes without the patient knowing, the results of the study after IVF are confidentially provided to a statistician for analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: in the control group for triggering the traditional HCG method with KARMA brand alone is given at a dose of 10,000 units. In the first intervention group HCG with KARMA brand at a dose of 5000 units with GNRHagonist and in the second intervention group recombinant HCG with OVITREEL brand dose 250 micrograms are given twice in 12 hours..</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hatav Ghasemi Tehrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine - Isfahan University of Medical Sciences - Hezar jarib Ave.</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746.</zip>
        <telephone>+98 913 113 4081</telephone>
        <email>Tehrani@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hatav Ghasemi Tehrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine - Isfahan University of Medical Sciences - Hezar jarib Ave.</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746.</zip>
        <telephone>+98 913 113 4081</telephone>
        <email>Tehrani@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>According to the Blogna (Bologna) criteria, people who meet the following two criteria are:1- Age over 40 years or risk factor to reduce ovarian reserve such as history of ovarian surgery, etc.2 - History of poor previous response to IVF (less than 3 oocytes in the previous cycle)Abnormal ovarian reserve test AFC (number of antral follicles) less than 5 to 7 or AMH (antimullerian hormone) less than 1/1</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>43 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients who become infected with the coronavirus during the cycle, patients who do not respond well to the ovulation stimulation cycle and do not actually have a follicle to empty, patients who mistakenly take medication during the cycle.</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: in the control group for triggering the traditional HCG method with KARMA brand alone is given at a dose of 10,000 units. In the first intervention group HCG with KARMA brand at a dose of 5000 units with GNRHagonist and in the second intervention group recombinant HCG with OVITREEL brand dose 250 micrograms are given twice in 12 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparison of the mean number of oocytes obtained and the rate of positive pregnancy serum test, frequency of pregnancy sac viscosity on ultrasound, frequency of fetal heart rate on ultrasound, frequency of pregnancy continuity up to 12 weeks of pregnancy are used in the three study groups. Timepoint: The time of oocyte count after ovuum pickup and the time of positive pregnancy test 2 weeks after embryo transfer and the time of pregnancy sac evaluation week after embryo transfer and the time of implantation test 5 weeks after embryo transfer and the time of pregnancy test 12 weeks in 12 weeks of pregnancy. Method of measurement: Evaluation of oocyte count after ovum pickup under a microscope to evaluate pregnancy test with HCG beta titration blood test and examination of pregnancy and pregnancy bags at 12 weeks with ultrasound.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nothing. Timepoint: nothing. Method of measurement: nothing.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-12</approval_date>
        <contact_name>دانشگاه علوم پزشکی اصفهان</contact_name>
        <contact_address>Isfahan University of Medical Sciences- Hezar jarib Ave. - Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
