<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/NCT04408547</url>
  </required_header>
  <id_info>
    <org_study_id>IakentroFC</org_study_id>
    <nct_id>NCT04408547</nct_id>
  </id_info>
  <brief_title>Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome</brief_title>
  <acronym>IAFACT</acronym>
  <official_title>Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Iakentro Fertility Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Iakentro Fertility Centre</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>
      Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014-&#xD;
      2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All&#xD;
      factors that might impact the embryo transfer will be analyzed. We want to see which factors&#xD;
      that influence the success rate are not related to the subjectivity of the operator and could&#xD;
      be adjusted through different approaches.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most patients undergoing IVF or ICSI reach a blastocyst embryo transfer but less achieve&#xD;
      pregnancy and live birth. Many reasons have been proposed to explain these results. Among&#xD;
      them, the factor Embryo Transfer Procedure gained less of the attention since few papers have&#xD;
      been published and most of them had a lot of biases. In order to eliminate possible biases,&#xD;
      we wanted to analyze our Embryo transfer data, prospectively collected during the last 6&#xD;
      years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers&#xD;
      since 1984. All factors that might impact the embryo transfer will be analyzed. We want to&#xD;
      see which factors that influence the success rate are not related to the subjectivity of the&#xD;
      operator and could be adjusted through different approaches.&#xD;
&#xD;
      Primary outcomes: bhCG positive rate, pregnancy rate, ongoing pregnancy rate, live birth&#xD;
      rate.&#xD;
&#xD;
      Secondary outcomes: Full bladder, uterine ax orientation, Endometrial thickness, type of&#xD;
      catheter, straightforward advancement of the preloaded catheter, use of a stiffer hard&#xD;
      catheter to pass through the cervix and the orifice, the site of the uterine cavity that the&#xD;
      embryo was released, single or double transfer due to blocked embryo in the catheter.&#xD;
&#xD;
      In addition for each embryo transfer variables that may influence the pregnancy rates will be&#xD;
      collected: age of the woman, number of oocytes harvested, sperm characteristics,&#xD;
      fertilization rate, stage and grade of the embryos the day of transfer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2014</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with bhCG positive test after embryo transfer</measure>
    <time_frame>Number of patients bhCG positive up to12 days after embryo transfer</time_frame>
    <description>Number of patients bhCG positive up to12 days after embryo transfer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with on going clinical pregnancy</measure>
    <time_frame>Number of patients with on going clinical pregnancy up to 12 weeks after embryo transfer</time_frame>
    <description>Number of patients with on going clinical pregnancy up to12 weeks after embryo transfer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of live births after embryo transfer</measure>
    <time_frame>Number oflive birth up to 9 months after embryo transfer</time_frame>
    <description>Number oflive birth up to9 months after embryo transfer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of fullnes of bladder</measure>
    <time_frame>At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer</time_frame>
    <description>Percentage of fullness of the bladder during embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometrial thickness</measure>
    <time_frame>prior to embryo transfer</time_frame>
    <description>Endometrial thickness prior to embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uterine axe orientation</measure>
    <time_frame>At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer</time_frame>
    <description>Uterine axe orientation during embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of embryo transfer catheter</measure>
    <time_frame>At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer</time_frame>
    <description>Type of embryo transfer catheter used in the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance from the fundus of the embryo release</measure>
    <time_frame>At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer</time_frame>
    <description>Distance from the fundus of the embryo release</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Embryo retained in the catheter</measure>
    <time_frame>Number of patients who underwent embryo transfer and the embryo was retained in the catheter at the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer</time_frame>
    <description>Embryo retained in the catheter</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3512</enrollment>
  <condition>IVF</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>soft catheter</arm_group_label>
    <description>Patients who underwent embryo transfer with a soft catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stiff catheter</arm_group_label>
    <description>Patients who underwent embryo transfer with a stiff catheter because soft couldn't pass</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>embryo transfer catheter</intervention_name>
    <description>undergoing embryo transfer</description>
    <arm_group_label>soft catheter</arm_group_label>
    <arm_group_label>stiff catheter</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing embryo transfer after IVF&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women undergoing embryo transfer after IVF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with known embryo implantation issues&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only women can undergo embryo transfer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IAKENTRO Fertility Center</name>
      <address>
        <city>Thessaloniki</city>
        <zip>542 50</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <results_reference>
    <citation>Prapas N, Prapas Y, Panagiotidis Y, Prapa S, Vanderzwalmen P, Makedos G. Cervical dilatation has a positive impact on the outcome of IVF in randomly assigned cases having two previous difficult embryo transfers. Hum Reprod. 2004 Aug;19(8):1791-5. doi: 10.1093/humrep/deh320. Epub 2004 Jun 3.</citation>
    <PMID>15178658</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Iakentro Fertility Centre</investigator_affiliation>
    <investigator_full_name>Yannis Prapas</investigator_full_name>
    <investigator_title>Professor of Obstetrics - Gynaecology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04408547
org study id: IakentroFC
nct id: NCT04408547
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014-
      2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All
      factors that might impact the embryo transfer will be analyzed. We want to see which factors
      that influence the success rate are not related to the subjectivity of the operator and could
      be adjusted through different approaches.
Most patients undergoing IVF or ICSI reach a blastocyst embryo transfer but less achieve
      pregnancy and live birth. Many reasons have been proposed to explain these results. Among
      them, the factor Embryo Transfer Procedure gained less of the attention since few papers have
      been published and most of them had a lot of biases. In order to eliminate possible biases,
      we wanted to analyze our Embryo transfer data, prospectively collected during the last 6
      years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers
      since 1984. All factors that might impact the embryo transfer will be analyzed. We want to
      see which factors that influence the success rate are not related to the subjectivity of the
      operator and could be adjusted through different approaches.

      Primary outcomes: bhCG positive rate, pregnancy rate, ongoing pregnancy rate, live birth
      rate.

      Secondary outcomes: Full bladder, uterine ax orientation, Endometrial thickness, type of
      catheter, straightforward advancement of the preloaded catheter, use of a stiffer hard
      catheter to pass through the cervix and the orifice, the site of the uterine cavity that the
      embryo was released, single or double transfer due to blocked embryo in the catheter.

      In addition for each embryo transfer variables that may influence the pregnancy rates will be
      collected: age of the woman, number of oocytes harvested, sperm characteristics,
      fertilization rate, stage and grade of the embryos the day of transfer
observational model: Cohort
time perspective: Prospective
measure: Number of patients with bhCG positive test after embryo transfer
time frame: Number of patients bhCG positive up to12 days after embryo transfer
description: Number of patients bhCG positive up to12 days after embryo transfer
measure: Number of patients with on going clinical pregnancy
time frame: Number of patients with on going clinical pregnancy up to 12 weeks after embryo transfer
description: Number of patients with on going clinical pregnancy up to12 weeks after embryo transfer
measure: Number of live births after embryo transfer
time frame: Number oflive birth up to 9 months after embryo transfer
description: Number oflive birth up to9 months after embryo transfer
measure: Percentage of fullnes of bladder
time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
description: Percentage of fullness of the bladder during embryo transfer
measure: Endometrial thickness
time frame: prior to embryo transfer
description: Endometrial thickness prior to embryo transfer
measure: Uterine axe orientation
time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
description: Uterine axe orientation during embryo transfer
measure: Type of embryo transfer catheter
time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
description: Type of embryo transfer catheter used in the procedure
measure: Distance from the fundus of the embryo release
time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
description: Distance from the fundus of the embryo release
measure: Embryo retained in the catheter
time frame: Number of patients who underwent embryo transfer and the embryo was retained in the catheter at the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
description: Embryo retained in the catheter
arm group label: soft catheter
description: Patients who underwent embryo transfer with a soft catheter
arm group label: stiff catheter
description: Patients who underwent embryo transfer with a stiff catheter because soft couldn't pass
intervention type: Device
intervention name: embryo transfer catheter
description: undergoing embryo transfer
arm group label: soft catheter
arm group label: stiff catheter
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Only women can undergo embryo transfer
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
facility: 
country: Greece
citation: Prapas N, Prapas Y, Panagiotidis Y, Prapa S, Vanderzwalmen P, Makedos G. Cervical dilatation has a positive impact on the outcome of IVF in randomly assigned cases having two previous difficult embryo transfers. Hum Reprod. 2004 Aug;19(8):1791-5. doi: 10.1093/humrep/deh320. Epub 2004 Jun 3.
PMID: 15178658
responsible party type: Principal Investigator
investigator affiliation: Iakentro Fertility Centre
investigator full name: Yannis Prapas
investigator title: Professor of Obstetrics - Gynaecology
sharing ipd: No