<?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>IRCT20200115046140N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-09</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>comparison of the consequences of fetal transfer method under the guidance of transvaginal ultrasound and guidance through trans Abdominal ultrasound</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study on some of the consequences of fetal transfer method under the guidance of transvaginal ultrasound and guidance through trans Abdominal ultrasound at Mahdieh Hospital in Tehran in 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47729</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 90 women candidates for IVF will be included in the study by simple randomly method. Using simple randomization method and individual unit, division of people into two groups will be done by Research Randomizer software, version 3.0 and random allocation with a ratio of 1: 1. In this software, a number will be assigned to each person entered in the study, and the software will randomly separate the numbers in two lists with a ratio of 1: 1.</study_design>
      <phase>N/A</phase>
      <hc_freetext>IVF.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: transfer of the fetus to the uterus under the guidance of abdominal ultrasound. In this group, embryo transfer will take place on days 2 or 3, because pregnancy and the rate of implantation are higher on these days. Initially, the vaginal will be impregnated with 10 cc of lubricating gel, and two SIVF catheters or Edwards-Wallace catheters will be used, depending on the operator's discretion. A rigid external transmission catheter in the cervical canal will also be studied. In this group, the bladder should be full. Honda device made in China with H-S2000 probe will be used for ultrasound. Intervention 2: Intervention group: transfer of the fetus to the uterus under the guidance of vaginal ultrasound. In this group, embryo transfer will take place on days 2 or 3, because pregnancy and the rate of implantation are higher on these days. Initially, the vagina will be impregnated with 10 cc of lubricating gel, and two SIVF catheters or Edwards-Wallace catheters will be used, depending on the operator's discretion. A rigid external transmission catheter in the cervical canal will also be studied. Honda device made in China with H-S2100 probe will be used for ultrasound.</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:
*

When:
*

To whom:
*

Conditions:
*

Where to obtain:
*

How to obtain:
*

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parya Geran Malekkheyli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Shahid Chamran Highway - Yemen Street - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2243 9770</telephone>
        <email>navid.khoshbakht@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parya Geran Malekkheyli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Shahid Chamran Highway - Yemen Street - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2243 9770</telephone>
        <email>navid.khoshbakht@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women candidates for IVF
Patients with antimullerian hormone more than 0.7
Women between 18 and 40 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The patient's reluctance to participate in the study
Patients with a poor ovarian response (in terms of number of antral follicles and antimullerian hormone)
Obesity (BMI above 35)
Uterus anatomical problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: transfer of the fetus to the uterus under the guidance of abdominal ultrasound. In this group, embryo transfer will take place on days 2 or 3, because pregnancy and the rate of implantation are higher on these days. Initially, the vaginal will be impregnated with 10 cc of lubricating gel, and two SIVF catheters or Edwards-Wallace catheters will be used, depending on the operator's discretion. A rigid external transmission catheter in the cervical canal will also be studied. In this group, the bladder should be full. Honda device made in China with H-S2000 probe will be used for ultrasound.</i_keyword>
      <i_keyword>Intervention group: transfer of the fetus to the uterus under the guidance of vaginal ultrasound. In this group, embryo transfer will take place on days 2 or 3, because pregnancy and the rate of implantation are higher on these days. Initially, the vagina will be impregnated with 10 cc of lubricating gel, and two SIVF catheters or Edwards-Wallace catheters will be used, depending on the operator's discretion. A rigid external transmission catheter in the cervical canal will also be studied. Honda device made in China with H-S2100 probe will be used for ultrasound.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain severity. Timepoint: During the ultrasound, At the end of the ultrasound. Method of measurement: Number one as the least pain and number ten as the most pain. Measuring of the variable will be done using the Numeric Pain Rating Scale method. In this method, the person rates their pain using a scale of 0 to 10. Zero means painless and 10 means the worst pain situation.</prim_outcome>
      <prim_outcome>Ultrasonic visualization of the doctor. Timepoint: At the end of the ultrasound. Method of measurement: Appropriate / inappropriate. This variable will be done by asking the doctor at the end of the ultrasound. In this way, the degree of difficulty and three-dimensional vision of the doctor using this method will be recorded based on the physician's opinion.</prim_outcome>
      <prim_outcome>Processing time. Timepoint: At the end of the ultrasound. Method of measurement: Second. The duration of the ultrasound at the end of the work will be recorded using a stopwatch in according to seconds.</prim_outcome>
      <prim_outcome>Successful pregnancy. Timepoint: It will be done 4 weeks after embryo transfer. Method of measurement: Yes/No. Successful pregnancy will be recorded using beta-HCG  measurement.</prim_outcome>
      <prim_outcome>Frequency of tenaculum. Timepoint: At the end of the ultrasound. Method of measurement: It was used or not. Using or not of tenaculum will be reported at the end of 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-06</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Tehran - Shahid Chamran Highway - Yemen Street - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
