<?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>IRCT20230702058644N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-12</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of patients with poor ovarian response included in the antagonist cycle during standard, dual and triple triggering in IVF outcomes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of patients with poor ovarian response included in the antagonist cycle during standard, dual and triple triggering in IVF outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71198</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Comparison of patients with poor ovarian response included in the antagonist cycle during standard, dual and triple triggering in IVF outcomes, Randomization description: The participants will be allocated to each study group by the balanced block randomization technique. The number of blocks and the size of each block are 36 and 3, respectively (َA, B, and C). The order of study groups in each block will determine the order of allocations.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Standard triggering via the injection of human gonadotropic hormone (hCG). Intervention 2: Intervention group 1: dual triggering via hCG and Decapeptyl. Intervention 3: Intervention group 2: triple triggering via administration of hCG, Decapeptyl, and menotropin.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
all collected deidentified IPD

When:
Our data can be potentially available on October 2023.

To whom:
People working in academic institutions

Conditions:
None

Where to obtain:
email address: zohrehmohammadi98@gmail.com

How to obtain:
Sending an email to the mentioned address and sending an identity proof that reveals the hiring academic institute is sufficient for us to share the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aliyeh Ghasemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138665793</zip>
        <telephone>+98 41 3177 1041</telephone>
        <email>alghasemzadeh@yahoo.co.uk</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aliyeh Ghasemzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138665793</zip>
        <telephone>+98 41 3177 1041</telephone>
        <email>alghasemzadeh@yahoo.co.uk</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>informed consent to participate in the study
Age between 24-42 years old
Body mass index of 19-27
The presence of POR (AFCI &lt;7, AMH &lt;1.5)
Eligibility of the patient for IVF
The absence of uterine abnormalities</inclusion_criteria>
      <agemin>24 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Hypothalamic dysfunctions in the patient
diabetes mellitus
liver diseases
heart diseases
renal diseases
epilepsy
metabolic disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>infertilefertility</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>Control group: Standard triggering via the injection of human gonadotropic hormone (hCG)</i_keyword>
      <i_keyword>Intervention group 1: dual triggering via hCG and Decapeptyl</i_keyword>
      <i_keyword>Intervention group 2: triple triggering via administration of hCG, Decapeptyl, and menotropin</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of good quality embryos. Timepoint: 3 days after fertilization. Method of measurement: High-quality cleavage stage embryos will have six cells or greater on day 3 and less than 10% fragmentation and symmetric blastomeres, according to the Istanbul consensus workshop.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of retrieved oocytes. Timepoint: 36 hours after triggering. Method of measurement: All oocyte retrievals will be performed under transvaginal ultrasound guidance and will be counted using light microscopy.</sec_outcome>
      <sec_outcome>The number of mature oocytes. Timepoint: 36 hours after triggering. Method of measurement: All oocyte retrievals will be performed under transvaginal ultrasound guidance and the number of mature oocytes will be counted using light microscopy.</sec_outcome>
      <sec_outcome>The number of clinical pregnancies. Timepoint: the presence of gestation sac two weeks after a positive hCG blood test. Method of measurement: ultrasound scan.</sec_outcome>
      <sec_outcome>Implantation rate. Timepoint: at 6–7 weeks of pregnancy. Method of measurement: Implantation rate is calculated from the number of gestational sacs with a visible fetal heart on ultrasound scan divided by the total number of transferred embryos.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-11</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Women's Reproductive Health Research Center, A lzahra Educational Hospital, Baghshomal square, South Artesh street, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
