<?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>IRCT2014032512494N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-03-25</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Beheshti University of Medical Science</primary_sponsor>
      <public_title>Comparison between conventional blind embryo transfer and embryo transfer based on previously measured uterine length</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the effect of conventional  embryo transfer and embryo transfer based on previously measured uterine length on pregnancy and implantation rates in fresh ART cycles in IVF ward of Taleghani Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12572</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group:&#13;
The type of stimulatory cycle (Agonist or Antagonist) were selected based on the age of woman and other factores. (agonist;Superfact: &#13;
mination Hoechst, Frankfurt, Germany)antagonist;cetrotide,EMDSerono,inc).Ovarian stimulation was done using r-FSH (GonalF;Serono,Laboratories.Ltd,Geneva,Switzerland),Merional or Fostimon ( IBSA,Switzerland), single or in combination.&#13;
When the leading follicles reachd 17-18mm in diameter HCG 10,000 unit (IBSA,Switzerland) was administered. The uterine length was measured, on the day of HCG administration, by recording the distance from the external os to the uterine fundus using vaginal sonography. Oocyte retrieval was performed 34-36 hours later. The day of embryo transfer is determined by convenience after 48-72 h. &#13;
Procedure:&#13;
All  women are placed in the lithotomy position (with an empty bladder) and a sterile metal speculum is placed to expose the cervix. The cervical mucus is cleaned using ringer solution and then the external os is washed with media (ham’s F 10 liquid).In all cases a Cook catheter ( COOK medical USA       ) are used. First the outer catheter and then the inner catheter that load the embryos is placed.  The site of embryo deposition in the uterus is determined based on uterine length measurement by vaginal ultrasound at the day of HCG  and embryo deposition is done in depth of 1-1.5 cm from the end of uterine cavity . Intervention 2: In control group:&#13;
 The type of stimulatory cycle (Agonist or Antagonist) are selected based on the age of woman and other factores. (agonist;Superfact: &#13;
mination Hoechst, Frankfurt, Germany)antagonist;cetrotide,EMDSerono,inc).Ovarian stimulation is done using r-FSH (GonalF;Serono,Laboratories.Ltd,Geneva,Switzerland),Merional or Fostimon ( IBSA,Switzerland), single or in combination.&#13;
When the leading follicles reachd 17-18mm in diameter HCG 10,000 unit (IBSA,Switzerland) is administered. The uterine length is measured, on the day of HCG administration, by recording the distance from the external os to the uterine fundus using vaginal sonography. Oocyte retrieval is performed 34-36 hours later. The day of embryo transfer is determined by convenience ,after 48 or 72h.&#13;
Procedure:&#13;
All  women are placed in the lithotomy position (with an empty bladder) and a sterile metal speculum is placed to expose the cervix. The cervical mucus is cleaned using ringer solution and then the external os is washed with media (ham’s F 10 liquid).In all cases a Cook catheter ( COOK medical USA       ) are used. First the outer catheter and then the inner catheter that loaded the embryos is placed. In this group  embryos are blindly deposited at the middle portion of the uterine cavity approximately at 5-6cm distance from the external os and based on physician experience.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Nasrin Saharkhiz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital, IVF ward, Velenjak, Shahid Chamran higway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2243 2558</telephone>
        <email>saharkhiz1377@yahoo.com</email>
        <affiliation>Infertility &amp; Reproductive Health Research Centre - Shahid Beheshti of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nasrin Saharkhiz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital, IVF ward, Velenjak, Shahid Chamran highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2243 2558</telephone>
        <email>saharkhiz1377@yahoo.com</email>
        <affiliation>Infertility &amp; Reproductive Health Research Centre - Shahid Beheshti of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
 All the patients who underwent ICSI in this period of time in our center that reached the embryo transfer step, were enrolled in the study.&#13;
 Exclusion criteria : &#13;
Egg donation cycles; embryo donation cycles;  frozen embryo transfers were excluded.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Not have</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Not have</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group:&#13;
The type of stimulatory cycle (Agonist or Antagonist) were selected based on the age of woman and other factores. (agonist;Superfact: &#13;
mination Hoechst, Frankfurt, Germany)antagonist;cetrotide,EMDSerono,inc).Ovarian stimulation was done using r-FSH (GonalF;Serono,Laboratories.Ltd,Geneva,Switzerland),Merional or Fostimon ( IBSA,Switzerland), single or in combination.&#13;
When the leading follicles reachd 17-18mm in diameter HCG 10,000 unit (IBSA,Switzerland) was administered. The uterine length was measured, on the day of HCG administration, by recording the distance from the external os to the uterine fundus using vaginal sonography. Oocyte retrieval was performed 34-36 hours later. The day of embryo transfer is determined by convenience after 48-72 h. &#13;
Procedure:&#13;
All  women are placed in the lithotomy position (with an empty bladder) and a sterile metal speculum is placed to expose the cervix. The cervical mucus is cleaned using ringer solution and then the external os is washed with media (ham’s F 10 liquid).In all cases a Cook catheter ( COOK medical USA       ) are used. First the outer catheter and then the inner catheter that load the embryos is placed.  The site of embryo deposition in the uterus is determined based on uterine length measurement by vaginal ultrasound at the day of HCG  and embryo deposition is done in depth of 1-1.5 cm from the end of uterine cavity .</i_keyword>
      <i_keyword>In control group:&#13;
 The type of stimulatory cycle (Agonist or Antagonist) are selected based on the age of woman and other factores. (agonist;Superfact: &#13;
mination Hoechst, Frankfurt, Germany)antagonist;cetrotide,EMDSerono,inc).Ovarian stimulation is done using r-FSH (GonalF;Serono,Laboratories.Ltd,Geneva,Switzerland),Merional or Fostimon ( IBSA,Switzerland), single or in combination.&#13;
When the leading follicles reachd 17-18mm in diameter HCG 10,000 unit (IBSA,Switzerland) is administered. The uterine length is measured, on the day of HCG administration, by recording the distance from the external os to the uterine fundus using vaginal sonography. Oocyte retrieval is performed 34-36 hours later. The day of embryo transfer is determined by convenience ,after 48 or 72h.&#13;
Procedure:&#13;
All  women are placed in the lithotomy position (with an empty bladder) and a sterile metal speculum is placed to expose the cervix. The cervical mucus is cleaned using ringer solution and then the external os is washed with media (ham’s F 10 liquid).In all cases a Cook catheter ( COOK medical USA       ) are used. First the outer catheter and then the inner catheter that loaded the embryos is placed. In this group  embryos are blindly deposited at the middle portion of the uterine cavity approximately at 5-6cm distance from the external os and based on physician experience.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical pregnancy. Timepoint: 2wks after embryo transfer. Method of measurement: Serum B-HCG.</prim_outcome>
      <prim_outcome>Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: Vaginal sonography.</prim_outcome>
      <prim_outcome>Ongoing pregnancy. Timepoint: 10 weeks after embryo transfer. Method of measurement: Vaginal sonography.</prim_outcome>
      <prim_outcome>Implantation rate. Timepoint: End of the study. Method of measurement: Number of gestational sacs at vaginal sonography divided by total number of transfered embryos.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Abortion rate. Timepoint: First trimester. Method of measurement: Clinical sign and vaginal ultrasound.</sec_outcome>
      <sec_outcome>Ectopic pregnancy rate. Timepoint: First trimester. Method of measurement: Clinical sign and vaginal ultrasound.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>not have</sec_id>
        <issuing_authority>not have</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Shahid Beheshti University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-09-26</approval_date>
        <contact_name>Infertility &amp; Reproductive Health Research Center Ethics committee of Shahid Beheshti University of </contact_name>
        <contact_address>Taleghani Hospital  3rd floor-Velenjak-Shahid Chamran highway-Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
