<?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>IRCT20190409043207N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-22</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two methods of double- trigger(GNRHa+HCG) and HCG-trigger on final oocyte maturation in normal responder patients.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two methods of double- trigger(GNRHa+HCG) and HCG-trigger on final oocyte maturation in normal responder patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41602</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method was simple randomization, so this method is based on a random number table. Thus, we assign 65 odd number to the case group and 65 even number to the control group. The patient randomly assigned to the one group by selecting one number, Blinding description: This study is double blind. The participant know abot study design but are blind and don't aware from grouping. Data analysor don't knows the groups as A and B and is unaware of type of treatment in each group.(double blind).</study_design>
      <phase>2</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Trigger with 0.2 mg deca peptil ampoule and 6500 HCG ampoule 40 and 34 hours before oocyte retriveal. Intervention 2: Intervention group: Trigger by standard method with 6500 units  HCG 36 hours beforeo oocyte retriveal.</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 data obtained from this study will be released after being unidentified studies participants.

When:
Get started 6 months after publishing study results

To whom:
The findings of this study will be accessible to all individuals.

Conditions:
To improve pregnancy outcomes in infertility clinics

Where to obtain:
Yazd Research and Clinical Center for Infertility

How to obtain:
Receiving the author's confirmation and obtaining approval from the director of the Yazd Infertility Clinic

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr maryam Mortazavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu ali Ave- Safaeieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3824 8119</telephone>
        <email>m_mortazavi58@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>دكتر مريم مرتضوي</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu ali Ave- Safaeieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3824 8119</telephone>
        <email>m_mortazavi58@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>normal responder women
Age less than 42 years
BMI &lt;30 Kg / m2
Estradiol Trigger Doses between 500 and 3000 pg / ml</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Severe male factor
Untreated thyroid disorders
Severe uterine anomaly
Existence of pco criteria
FSH&gt; 10 days of the third menstrual cycle and AMH &lt;1
BMI less than 18 and more than 35
Predicting the the chance of of ovarian hyper stimulation syndrom(OHSS)
Hyperprolactinemia
Endocrine Disorders
Congenital adrenal hyperplasia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complication associated with artificial fertilization, unspecified</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: Trigger with 0.2 mg deca peptil ampoule and 6500 HCG ampoule 40 and 34 hours before oocyte retriveal.</i_keyword>
      <i_keyword>Intervention group: Trigger by standard method with 6500 units  HCG 36 hours beforeo oocyte retriveal.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of follicles. Timepoint: From the tenth day of the cycle. Method of measurement: sonography.</prim_outcome>
      <prim_outcome>Number of recovered oocytes. Timepoint: Oocyte recovery day. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Number of canceled cycles. Timepoint: Oocyte recovery day. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Number of embryo. Timepoint: 2 days after Oocyte recovery. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Embryo grading. Timepoint: 3 days after Oocyte recovery. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Number of transfered embryo. Timepoint: embryo  transfere day. Method of measurement: observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chemical pregnancy rate. Timepoint: 14 days after embryo transfer. Method of measurement: positive B-HCG.</sec_outcome>
      <sec_outcome>Clinical pregnancy rate. Timepoint: 4 weeks after embryo transfer. Method of measurement: fetal heart rate in sonography.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-28</approval_date>
        <contact_name>SShahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Bouali Ave, Safayeh. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
