<?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>IRCT201708292604N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-18</date_registration>
      <primary_sponsor>Yazd Reproductive Sciences Institute, Shahid Sadoughi University</primary_sponsor>
      <public_title>ٍٍEffect of GnRH-a in endometrial preparation for frozen-thawed embryo transfer cycles in patient with repeated implantation failure.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of GnRH-a in endometrial preparation for frozen-thawed embryo transfer cycles in patient with repeated implantation failure.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>67</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2385</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups of 34 patients according to permutation block method of control and  intervention. 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.
There are  8 blocks in each,is 8 numbers  in order to  reaches sample size to  64 and one block of 4 is 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 67 is given.Using a table generated by random allocation software by number, individuals are placed in the control and intervention group.
The output of Random allocation software version 1 is specified as A and B in the specified blocks, which describe the number of blocks and the number of patients in each block.</study_design>
      <phase>2-3</phase>
      <hc_freetext>repeated implantation failure.</hc_freetext>
      <i_freetext>Intervention 1: In case group ,  patients receive daily subcutaneous  injections of 0.1 mg of GnRH-a( diphereline) starting from day 21 of previous cycles.The dose is reduce to 0.05 mg from the second day of cycle when daily oral estradiol valerate 6mg is also started.Daily vaginal progesterone 400mg  twice daily is started when endometrial thickness is &gt; 7.5 mm and  GnRH_a  is also stopped. Intervention 2: In control group oral estradiol 6mg daily is started from day 2 cycle without diphereline. Daily vaginal progesterone 400mg twice daily is started when endometrial thickness is &gt; 7.5 mm.</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:
participant data set able to be shared

When:
2 months after publication

To whom:
Journal that published the results

Conditions:
A person/office that is legally in charge

Where to obtain:
Yazd Reproductive Sciences Institute
983538247085
saeideh_dashti@yahoo.com

How to obtain:
Submission of legal order

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Robab Davar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd Reproductive Sciences Institute,Bouali Ave. Safaeiye</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3824 7085</telephone>
        <email>r_davar@yahoo.com</email>
        <affiliation>Yazd Reproductive Sciences Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Robab Davar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd Reproductive Sciences Institute,Bouali ave. safaeiye</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3824 7085</telephone>
        <email>r_davar@yahoo.com</email>
        <affiliation>Yazd Reproductive Sciences Institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>infertile women  with at least 2 previous failed implantation.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Endometrial polyp
myoma
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>In case group ,  patients receive daily subcutaneous  injections of 0.1 mg of GnRH-a( diphereline) starting from day 21 of previous cycles.The dose is reduce to 0.05 mg from the second day of cycle when daily oral estradiol valerate 6mg is also started.Daily vaginal progesterone 400mg  twice daily is started when endometrial thickness is &gt; 7.5 mm and  GnRH_a  is also stopped.</i_keyword>
      <i_keyword>In control group oral estradiol 6mg daily is started from day 2 cycle without diphereline. Daily vaginal progesterone 400mg twice daily is started when endometrial thickness is &gt; 7.5 mm</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: serum BHCG.</prim_outcome>
      <prim_outcome>Clinical pregnancy. Timepoint: 2 wk after positive β hCG. Method of measurement: the detection of a fetal heartbeat in sonography.</prim_outcome>
      <prim_outcome>Implantation rate. Timepoint: 2 wk after positive β hCG. Method of measurement: the number of gestational sacs per embryos transferred.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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 Reproductive Sciences Institute, Shahid Sadoughi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-21</approval_date>
        <contact_name>Ethics Committee of Yazd  Reproductive Sciences institute shahid sadoughi university</contact_name>
        <contact_address>Yazd Reproductive Sciences Institute Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
