<?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>IRCT2016092224512N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-03</date_registration>
      <primary_sponsor>Research Deputy, Shahid Sadoughi University of Medical Sciences</primary_sponsor>
      <public_title>Pregnancy outcome in Fresh versus Freeze embryo transfer</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Fresh  and Frozen Embryo Transfer in GnRH Agonist Triggered patients: A Multicenter Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>1280</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20671</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this multicenter, randomized clinical trial, 280 infertile women at risk of OHSS were enrolled in the study. All patients were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Freeze of all embryos according to embryo freezing standard protocol at the same cycle.                   Thaw all the embryos according to embryo thawing standard protocol and embryo transfer at the next cycle. Intervention 2: Intervention group 2: Transfer of 2 fresh embryos at the same cycle Luteal phase support using oral Estradiol Valerat at the dose of 4 mg per day and progesterone (Cyclogest 400 mg) twice daily until observation of fetal heart activity.</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 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, Bouali Ave, Yazd, Iran.
983538247085
abbas_aflatoonian@yahoo.com

How to obtain:
2 months after application

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Tabibnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave, Safayieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3824 8121</telephone>
        <email>nasimtabibnejad@ssu.ac.ir</email>
        <affiliation>Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas aflatoonian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave, Safayieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3824 8121</telephone>
        <email>abbas-aflatoonian@ssu.ac.ir</email>
        <affiliation>Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20-40
Hyper responded patients
Detection of 14-25 follicles ≥ 12 mm on day of trigger
BMI &gt;18 and &lt;35 kg/m2</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients with &lt;14 follicles and &gt; 25 ≥ 12 mm on day of trigge
Previous OHSS
Endocrine disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>inability to achieve a pregnancy sterility, female NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Freeze of all embryos according to embryo freezing standard protocol at the same cycle.                   Thaw all the embryos according to embryo thawing standard protocol and embryo transfer at the next cycle</i_keyword>
      <i_keyword>Intervention group 2: Transfer of 2 fresh embryos at the same cycle Luteal phase support using oral Estradiol Valerat at the dose of 4 mg per day and progesterone (Cyclogest 400 mg) twice daily until observation of fetal heart activity</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical pregnancy rate. Timepoint: 7 weeks after embryo transfer. Method of measurement: Fetal heart rate in ultra sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chemical pregnancy rate. Timepoint: 14 days after embryo transfer. Method of measurement: Beta-hCG using lab kit.</sec_outcome>
      <sec_outcome>Livebirth. Timepoint: 36 weeks after embryo transfer. Method of measurement: A live-born baby.</sec_outcome>
      <sec_outcome>Ovarian hyperstimulation syndrome. Timepoint: During ovarian stimulation. Method of measurement: Measurement of serum anti mullerian hormone level and antral follicle count.</sec_outcome>
      <sec_outcome>Perinatal outcome. Timepoint: After live birth. Method of measurement: weight measurement, prematurity status.</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>Research Deputy, Shahid Sadoughi University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-09</approval_date>
        <contact_name>Research and Clinical center for Infertility, Shahid Sadoughi University of medical Sciences</contact_name>
        <contact_address>Bouali Ave, Safayieh Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
