<?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>IRCT2016111628756N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-04</date_registration>
      <primary_sponsor>shahid saoughi university of medical science</primary_sponsor>
      <public_title>A comparison of Dual triggering by administration of GnRH agonist plus HCG versus HCG  in poor  responders in ART outcomes</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of Dual triggering versus HCG  in poor  responders in ART outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23243</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are admitted to two groups of 41 patients on the basis of permutation block method. Therapeutic tasks within the blocks are determined in such a way that they are random, but the desired allocation ratio is achieved in each block.
20 blocks of 4 and a block of 2 are considered. Generate random codes using random block allocation method which will be generated with the help of Random allocation software version 1. The first person eligible to enter the study is given number one and so on until the last person eligible for number 82 is given. Using a table generated by random allocation software by number, people receive intervention A or B. In order to be blind, the random allocation of this list is given to another person outside the study, and by sending a text message before assigning the type of treatment, the eligible person is asked according to the number, and thus the people enter the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: in intervention group co-administration of  HCG and agonist used for triggering. Intervention 2: in control group HCG used routinely for triggering.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Abstract
Background
The use of dual triggering in high and normal responders accompanied with better IVF cycle outcomes. Also, it has been suggested that dual triggering in poor responders can be accompanied by better results.

Objective
The aim of present study was to evaluate whether the Dual trigger, can improve oocyte maturation in poor responder patients based on Bologna criteria and their ART outcomes.


Materials and methods
All poor ovarian responder's patients underwent GnRH antagonist controlled ovarian hyperstimulation protocols in ART cycles. The participants' randomizations were done and patients divided into two groups. In the first group, final oocyte maturation was done by 6500 I.U.HCG alone. In the second group, triggering was done with coadministration of 6500 I.U.HCG plus 0.2 mg triptorelin simultaneous (dual trigger). Oocyte retrieval was performed 36 h after triggering through transvaginal ultrasound-guided. Routine IVF/ICSI was performed as appropriate.

Results
The number of retrieved oocytes, number of mature oocytes (MII), number of fertilized oocytes (2PN), number of embryo formation, number of transferred embryos and embryo quality have not significant differences between the two groups (p &gt; 0.05). Also, fertilization and implantation rate, chemical and clinical pregnancy did not differ between groups.

Conclusion
Dual triggering for final oocyte maturation in poor ovarian responders did not improve the number of mature oocytes (MII) and other ART cycle results.</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 participant data sets are to be shared

When:
2 months after the result publication

To whom:
A journal in which the results are published

Conditions:
Submission of an official application via the agent that is legally in charge

Where to obtain:
Yazd Reproductive Sciences Institute

How to obtain:
Submission of an official application

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Naghshineh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Booali/Safaieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3824 7085</telephone>
        <email>naghshineh@med.mui.ac.ir</email>
        <affiliation>research and clinical center for infertility</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Booali/Safaieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>38247085</zip>
        <telephone>+98 35 3824 7085</telephone>
        <email>eftekhar@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>poor ovarian responders women (based on Bologna criteria)
GnRH antagonist protocols
fresh embryo transfer</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>endometrial polyps
presence of endocrine disorders (such as hyperprolactinemia, hypothyroidism)
preimplantation genetic diagnosis cycles
non fresh embryo transfer cycles.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility of other origin</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>in intervention group co-administration of  HCG and agonist used for triggering</i_keyword>
      <i_keyword>in control group HCG used routinely for triggering</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of metaphase II oocytes. Timepoint: After intervention. Method of measurement: number.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of fertilized oocytes (2PN). Timepoint: after intervention. Method of measurement: number.</sec_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 28 days after transfer. Method of measurement: 28 days after transfer.</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>shahid saoughi university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-14</approval_date>
        <contact_name>Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Bouali Avenue, Safayeh,Yazd,Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
