<?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>IRCT20190409043207N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-22</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the oocyte quality in patients with poor ovarian response undergone two triggering methods.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two methods of double- trigger (GNRHa+HCG) and HCG-trigger on the final oocyte maturation in poor responder patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>122</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41606</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization selection of the patients, through the site www. randomization.ir, we create a list of random numbers for assigning patients to treatment groups (A&amp;B). Then, the number of each patient, which is according to the entrance number to the clinic, is written on the envelope, and the type of treatment that was randomly selected through the mentioned site is put in the envelope. Also, thick envelopes are used in the aim to not be identifiable, the type of treatment for each patient, in the envelope, by the people who make the random assignment of the patient. In this way, each patient, who refer for giving treatment, comes with an envelope containing the type of assigned treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Trigger with 0.2 mg deca peptil ampoule and 10000 HCG ampoule 40 and 34 hours before oocyte retrieval. Intervention 2: Intervention group: Trigger by standard method with 10000units HCG 36 hours before oocyte retrieval.</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 the study results

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

Conditions:
To improve pregnancy outcomes of the infertility centers

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>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>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age more than 40 years or other risk factors for poor ovarian response.
Less than three oocytes in the previous IVF cycle
Abnormal ovarian reserve test
Two histories of poor ovarian response following receiving maximal stimulation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Severe male factor
Untreated endocrine disorders
Severe uterine anomaly</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: Intervention group: Trigger with 0.2 mg deca peptil ampoule and 10000 HCG ampoule 40 and 34 hours before oocyte retrieval.</i_keyword>
      <i_keyword>Intervention group: Trigger by standard method with 10000units HCG 36 hours before oocyte retrieval.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical pregnancy rate. Timepoint: Four weeks after positive beta hCG. Method of measurement: Fetal heart activity by trans-vaginal ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Biochemical pregnancy rate. Timepoint: 14 days after embryo transfer. Method of measurement: Positive B-HCG.</sec_outcome>
      <sec_outcome>Implantation rate. Timepoint: 4 weeks after embryo transfer. Method of measurement: It is defined as the numbers of gestational sacs that detected throughout sonography per number of embryos transferred (100 embryo).</sec_outcome>
      <sec_outcome>Abortion rate. Timepoint: Before 20th weeks of gestation. Method of measurement: Observation and counting.</sec_outcome>
      <sec_outcome>COC counting. Timepoint: The day of oocyte puncture. Method of measurement: Counting.</sec_outcome>
      <sec_outcome>MII oocyte number. Timepoint: The day of puncture. Method of measurement: Counting.</sec_outcome>
      <sec_outcome>2PN number. Timepoint: 1 day after fertilization. Method of measurement: Counting.</sec_outcome>
      <sec_outcome>Estradiol level. Timepoint: In the day of hCG injection. Method of measurement: Biochemical measurements in the blood.</sec_outcome>
      <sec_outcome>Embryo grading. Timepoint: 3 days after puncture. Method of measurement: Observation and grading according to the embryo references.</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>Ethics Committee of Shahid 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>
