<?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>IRCT2015031221420N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-06-25</date_registration>
      <primary_sponsor>shahid sadoughi university of medical sciences</primary_sponsor>
      <public_title>Dual triggering in improving assisted reproductive programs outcome</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of Dual triggering by administration of Gonadotropin releasing hormon  agonist plus human chorionic gonadotropin versus HCG  in normal responders at assisted reproductive programs outcome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>223</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18778</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization was done by table of random numbers, Blinding description: Patients were named as groups 1 and 2. And the statistical analyzer did not know the type of treatment protocol used in each group.</study_design>
      <phase>2</phase>
      <hc_freetext>female infertility.</hc_freetext>
      <i_freetext>Intervention 1: control group receive 6500 I.U hCG IM for triggering final oocyte maturation . Intervention 2: Intervention group receive 6500 I.U. IM hCG+triptorelin0.2mg/sc 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:

Gonadotropin-releasing hormone agonists (GnRH-a) was increasingly used for triggering oocyte maturationfor the prevention of ovarian hyperstimulation syndrome. Studies suggest that GnRH-a might be used as a better trigger agent since it causes both Luteinizing hormone and follicle stimulating hormone release from a physiologic natural cycle.
Objective:

The aim of this study was to evaluate the effect of dual-triggering in assisted reproductive technology outcomes.
Materials and Methods:

192 normal responder women aged ≤42 years and 18&lt; Body Mass Index &lt;30 kg/m2 enrolled in this single-blind randomized controlled trial. All participants received antagonist protocol. For final triggering, women randomly were divided into two groups. Group, I was triggered by 6500 IU human chorionic gonadotropin (hCG) alone, and group II by 6500 IU hCG plus 0.2 mg of triptorelin. The implantation, chemical, clinical and ongoing pregnancy, and abortion rates were measured.
Results:

The mean of retrieved oocytes and obtained embryos were statistically higher in the dual-trigger group (group I), but the implantation and pregnancy rates were similar in two groups.
Conclusion:

The results of our study did not confirm the favorable effect of dual-triggered oocyte maturation with a GnRH-a and a standard dosage of hCG as an effective strategy to optimize pregnancy outcome for normal responders in GnRH-antagonist cycles. We think that this new concept requires more studies before becoming a universal controlled ovarian hyperstimulation protocol in in vitro fertilization practice.</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>Maryam Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Avenue, Safayeh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3824 7085</telephone>
        <email>eftekhar@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Avenue, Safayeh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</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>normal responder women by tubal or male infertility factor, 18&lt; Body mass index &lt;30 kg/m2, and age ≤42 yr with the history of infertility for at least 1 yr that were candidate for ART protocol</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>the presence of endocrine disorders such as diabetes mellitus, hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, Cushing syndrome, polycystic ovary syndrome, congenital uterine anomaliesdisorders, repeated implantation failure, day-3 FSH concentration ≥10 IU/L or serum anti-Mullerian hormone ≤1.0 ng/mL, and azoospermia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility, 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>control group receive 6500 I.U hCG IM for triggering final oocyte maturation .</i_keyword>
      <i_keyword>Intervention group receive 6500 I.U. IM hCG+triptorelin0.2mg/sc for triggering.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical pregnancy rate. Timepoint: 28 days after transfer. Method of measurement: vaginal sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chemical pregnancy rate. Timepoint: 14 days after transfer. Method of measurement: BhCG test.</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 sadoughi university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-22</approval_date>
        <contact_name>Yazd Research and Clinical Center for infertility</contact_name>
        <contact_address>Bouali Avenue, Safayeh yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
