<?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>IRCT20160717028967N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-01</date_registration>
      <primary_sponsor>Vice chancellor for research, Avicenna infertility center</primary_sponsor>
      <public_title>The effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of long term Gnrh agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis in avecinna infertility center in 2‌‌ 018_2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36103</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 equal groups (A and B) based on a randomized six-block table that is designed by Random allocation software.</study_design>
      <phase>2</phase>
      <hc_freetext>People with Adenomyosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The GnRH agonist group treated with a 11.25 mg intramuscular Triptorelin in the 3th menstural cycle day and after 12 weeks hormone replacement therapy starts with estradiol valerate. Then subjects will be followed with serial transvaginal ultrasound and after reaching to the endometrial thickness of 7 mm, progesterone will be added to the treatment and after 3 to 5 days embryo transfer will be performed. Intervention 2: Control group: In the control group the standard treatment begins with a 21 days of low dose contraceptives from the 3th day of the menstural cycle and a 1.875 mg intramuscular dose of Triptorelin in the 21th day of menstural cycle and the hormone replacement therapy starts with estradiol valerate in the next menstural cycle. Then subjects will be followed with serial transvaginal ultrasound and after reaching to the endometrial thickness of 7 mm, progesterone will be added to the treatment and after 3 to 5 days embryo transfer will be performed.</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:
I have no plans at this time

When:
I have no plans at this time

To whom:
I have no plans at this time

Conditions:
I have no plans at this time

Where to obtain:
I have no plans at this time

How to obtain:
I have no plans at this time

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Soheila Ansaripour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 97, Yakhchal junction, Shariati street, Avecinna infertility center,Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 0982123519</telephone>
        <email>Soh.ansaripour@gmail.com</email>
        <affiliation>Avecinna infertility center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Soheila Ansaripour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 97, Yakhchal junction, Shariati street, Avicenna infertility center,Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>Soh.ansaripour@gmail.com</email>
        <affiliation>Avicenna infertility center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having at least 2 criteria in sonography
Age between 20 to 40 years old
The candidate for  frozen embryo transfer
The embryo has a quality A or blastocyst</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Recurrent abortion
Azospermia in sperm analysis of male partner
Uncontrolled medical condition
Abnormal karyotype
Uterine  abnormal anatomy
Immune and coagulation dysfunction
Using immune suppressive medications
Using immune suppressive medications
Using another treatments for improvement of fertility success rate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis</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: The GnRH agonist group treated with a 11.25 mg intramuscular Triptorelin in the 3th menstural cycle day and after 12 weeks hormone replacement therapy starts with estradiol valerate. Then subjects will be followed with serial transvaginal ultrasound and after reaching to the endometrial thickness of 7 mm, progesterone will be added to the treatment and after 3 to 5 days embryo transfer will be performed.</i_keyword>
      <i_keyword>Control group: In the control group the standard treatment begins with a 21 days of low dose contraceptives from the 3th day of the menstural cycle and a 1.875 mg intramuscular dose of Triptorelin in the 21th day of menstural cycle and the hormone replacement therapy starts with estradiol valerate in the next menstural cycle. Then subjects will be followed with serial transvaginal ultrasound and after reaching to the endometrial thickness of 7 mm, progesterone will be added to the treatment and after 3 to 5 days embryo transfer will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy rate. Timepoint: 14 and 16 days after embryo transfer. Method of measurement: Beta test.</prim_outcome>
      <prim_outcome>Clinical pregnancy rate. Timepoint: 6th week of pregnancy. Method of measurement: With sonography.</prim_outcome>
      <prim_outcome>Ongoing pregnancy rate. Timepoint: 7th week of pregnancy. Method of measurement: With sonography.</prim_outcome>
      <prim_outcome>Abortion rate before 12 weeks. Timepoint: 12th week of pregnancy. Method of measurement: With sonography.</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>Vice chancellor for research, Avicenna infertility center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-20</approval_date>
        <contact_name>Ethics committee of Avecinna infertility center</contact_name>
        <contact_address>No 97, Yakhchal junction, Shariati street, Avecinna infertility center. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
