<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03756857</url>
  </required_header>
  <id_info>
    <org_study_id>AcibademKD</org_study_id>
    <nct_id>NCT03756857</nct_id>
  </id_info>
  <brief_title>Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?</brief_title>
  <official_title>Comparison of IVF Success Rates Between Different Embryo Transfer Techniques: Afterload Technique and Trial Followed by Transfer Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem Kadiköy Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acibadem Kadiköy Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate&#xD;
      between most commonly used two embryo transfer techniques: trial followed by transfer&#xD;
      technique and afterloading technique&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will be informed about the possibility of participating in the clinical&#xD;
      trial in the beginning of treatment and on the day ET, a signed consent form will be&#xD;
      collected from those recipients who confirmed their participation. These patients will be&#xD;
      randomized immediately before the ET procedure by sequentially numbered, opaque, sealed&#xD;
      envelopes&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective, open, randomized, parallel, two-arm trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>5-6 weeks after embryo transfer</time_frame>
    <description>the presence of gestational sac on ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>implantation rate</measure>
    <time_frame>3-4 weeks after embryo transfer</time_frame>
    <description>the number of gestational sacs divided by the number of embryos transferred</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Infertility</condition>
  <condition>Assisted Reproductive Technology</condition>
  <condition>IVF</condition>
  <arm_group>
    <arm_group_label>Afterload transfer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trial Followed by Transfer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Afterload Transfer</intervention_name>
    <description>Embryo transfer is done by using &quot;afterload transfer&quot; method</description>
    <arm_group_label>Afterload transfer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trial followed by transfer</intervention_name>
    <description>Embryo transfer is done by using &quot;afterload transfer&quot; method</description>
    <arm_group_label>Trial Followed by Transfer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient has given written informed consent&#xD;
&#xD;
          2. BMI 18-30 kg/m2&#xD;
&#xD;
          3. &lt; 2 previous failed IVF trials&#xD;
&#xD;
          4. At least two good quality embryos on the day of transfer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Congenital uterine anomaly&#xD;
&#xD;
          2. Untreated endometrial polyp or fibroid distorting uterine cavity&#xD;
&#xD;
          3. Presence of hydrosalpinx 4.2 or more prior IVF trial failure&#xD;
&#xD;
        5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>37 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elif Esra UYAR, MD</last_name>
    <phone>+902166494444</phone>
    <email>esra.uyar@acibadem.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Acibadem Altunizade Hospital, Unit of ART</name>
      <address>
        <city>İstanbul</city>
        <zip>34662</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elif Esra Uyar, MD</last_name>
      <phone>+902166494444</phone>
      <email>esra.uyar@acibadem.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>March 21, 2021</last_update_submitted>
  <last_update_submitted_qc>March 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Acibadem Kadiköy Hospital</investigator_affiliation>
    <investigator_full_name>deniz usal</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03756857
org study id: AcibademKD
nct id: NCT03756857
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate
      between most commonly used two embryo transfer techniques: trial followed by transfer
      technique and afterloading technique
Eligible patients will be informed about the possibility of participating in the clinical
      trial in the beginning of treatment and on the day ET, a signed consent form will be
      collected from those recipients who confirmed their participation. These patients will be
      randomized immediately before the ET procedure by sequentially numbered, opaque, sealed
      envelopes
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, open, randomized, parallel, two-arm trial
primary purpose: Treatment
masking: None (Open Label)
measure: clinical pregnancy rate
time frame: 5-6 weeks after embryo transfer
description: the presence of gestational sac on ultrasound
measure: implantation rate
time frame: 3-4 weeks after embryo transfer
description: the number of gestational sacs divided by the number of embryos transferred
arm group label: Afterload transfer
arm group type: Experimental
description: First, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician.
arm group label: Trial Followed by Transfer
arm group type: Experimental
description: First a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed
intervention type: Procedure
intervention name: Afterload Transfer
description: Embryo transfer is done by using "afterload transfer" method
arm group label: Afterload transfer
intervention type: Procedure
intervention name: Trial followed by transfer
description: Embryo transfer is done by using "afterload transfer" method
arm group label: Trial Followed by Transfer
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 37 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elif Esra UYAR, MD
phone: +902166494444
email: esra.uyar@acibadem.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Acibadem Kadiköy Hospital
investigator full name: deniz usal
investigator title: Medical Doctor
mesh term: Infertility