xml: <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/NCT06019494</url>
    </required_header>
    <id_info>
      <org_study_id>Flow rate for oocyte retrieval</org_study_id>
      <nct_id>NCT06019494</nct_id>
    </id_info>
    <brief_title>Comparison of 2 Different Flow Rates During Oocyte Retrieval</brief_title>
    <official_title>Is Flow Rate During Oocyte Retrieval Associated With the Number of Oocytes Retrieved? A Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eugonia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aristotle University Of Thessaloniki</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Eugonia</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>
        The purpose of this study is to evaluate the effect of different flow rates during oocyte&#xD;
        retrieval, on the number of cumulus oocyte complexes (COCs) retrieved.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the current study, each ovary will be randomly allocated to oocyte retrieval using 0.42&#xD;
        ml/sec or 0.62 ml/sec flow rate.&#xD;
  &#xD;
        The primary endpoint will be the number of oocytes retrieved, while secondary outcomes will&#xD;
        include oocyte recovery rate (number of oocytes retrieved per follicle aspirated), number of&#xD;
        mature oocytes, maturation rate (number of mature oocytes/number of oocytes retrieved), mean&#xD;
        oocyte score (by evaluating oocyte shape and size, ooplasm characteristics, structure of&#xD;
        perivitelline space (PVS), structure of zona pellucida (ZP) and polar body (PB) morphology),&#xD;
        fertilization rate (number of fertilized oocytes/number of mature oocytes), number of&#xD;
        blastocysts and blastulation rate (number of blastocysts/number of 2PN).&#xD;
  &#xD;
        Patients aged &lt;43 years with the presence of at least 3 follicles ≥ 11mm in each ovary on the&#xD;
        day of oocyte retrieval will be eligible for inclusion in the study.&#xD;
  &#xD;
        Prior to oocyte retrieval in eligible patients their left and right ovary will be randomly&#xD;
        allocated into the 0.42 ml/sec or 0.62 ml/sec flow rate group. Randomisation with&#xD;
        minimisation will be employed.&#xD;
  &#xD;
        The specific flow rates will be achieved by adjusting the aspiration pressure of the vacuum&#xD;
        pump accordingly. A study nurse will be responsible for adjusting the aspiration pressure of&#xD;
        the vacuum pump depending on randomization. The doctor performing the oocyte retrieval will&#xD;
        not be aware of the flow rate used in each ovary.&#xD;
  &#xD;
        All follicles will be aspirated and then flushed if needed up to a maximum of 5 times with an&#xD;
        open flushing technique, using a 17G double-lumen needle.&#xD;
  &#xD;
        Data will be registered regarding the number of flushes required to retrieve a COC, the&#xD;
        morphology of oocytes after denudation, oocyte fertilisation and embryo development up to the&#xD;
        blastocyst stage.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of oocytes retrieved</measure>
      <time_frame>During oocyte retrieval</time_frame>
      <description>Number of oocytes retrieved per ovary randomised.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Oocyte recovery rate</measure>
      <time_frame>During oocyte retrieval</time_frame>
      <description>Number of oocytes retrieved per follicle aspirated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oocyte maturation rate</measure>
      <time_frame>2-3 hours post oocyte retrieval</time_frame>
      <description>Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average oocyte score</measure>
      <time_frame>2-3 hours post oocyte retrieval</time_frame>
      <description>Average oocyte score based on the evaluation of oocyte shape and size, ooplasm characteristics, structure of perivitelline space, structure of zona pellucida and polar body morphology.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fertilization rate</measure>
      <time_frame>Day 1 post oocyte retrieval</time_frame>
      <description>Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of good quality blastocysts on day 5</measure>
      <time_frame>5 days post oocyte retrieval</time_frame>
      <description>Number of good quality blastocysts divided by the number of fertilized oocytes per ovary randomised.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">39</enrollment>
    <condition>Infertility</condition>
    <arm_group>
      <arm_group_label>Low aspiration flow rate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High aspiration flow rate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Oocyte retrieval with low aspiration flow rate</intervention_name>
      <description>All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.42 ml/sec.</description>
      <arm_group_label>Low aspiration flow rate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Oocyte retrieval with high aspiration flow rate</intervention_name>
      <description>High aspiration flow rate All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.62 ml/sec.</description>
      <arm_group_label>High aspiration flow rate</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Presence of both ovaries&#xD;
  &#xD;
            -  18-43 years old&#xD;
  &#xD;
            -  At least two follicles &gt;14mm present in each ovary on day of triggering final oocyte&#xD;
               maturation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  One or no ovaries present&#xD;
  &#xD;
            -  Monofollicular development&#xD;
  &#xD;
            -  Poor responders&#xD;
  &#xD;
            -  Previous history of hemorrhage during oocyte retrieval&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Participants must have both ovaries present</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>43 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>George T Lainas, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Eugonia ART Unit</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>George T Lainas, PhD</last_name>
      <phone>+302107236333</phone>
      <email>ggslns@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tryfon G Lainas, PhD</last_name>
      <phone>+302107236333</phone>
      <email>tlainas@eugonia.com.gr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Eugonia Unit of Assisted Reproduction</name>
        <address>
          <city>Athens</city>
          <zip>11528</zip>
          <country>Greece</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <reference>
      <citation>Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.</citation>
      <PMID>26630267</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Flow rate</keyword>
    <keyword>Aspiration pressure</keyword>
    <keyword>Oocyte retrieval</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019494
  org study id: Flow rate for oocyte retrieval
  nct id: NCT06019494
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the effect of different flow rates during oocyte
        retrieval, on the number of cumulus oocyte complexes (COCs) retrieved.
  In the current study, each ovary will be randomly allocated to oocyte retrieval using 0.42
        ml/sec or 0.62 ml/sec flow rate.
  
        The primary endpoint will be the number of oocytes retrieved, while secondary outcomes will
        include oocyte recovery rate (number of oocytes retrieved per follicle aspirated), number of
        mature oocytes, maturation rate (number of mature oocytes/number of oocytes retrieved), mean
        oocyte score (by evaluating oocyte shape and size, ooplasm characteristics, structure of
        perivitelline space (PVS), structure of zona pellucida (ZP) and polar body (PB) morphology),
        fertilization rate (number of fertilized oocytes/number of mature oocytes), number of
        blastocysts and blastulation rate (number of blastocysts/number of 2PN).
  
        Patients aged <43 years with the presence of at least 3 follicles ≥ 11mm in each ovary on the
        day of oocyte retrieval will be eligible for inclusion in the study.
  
        Prior to oocyte retrieval in eligible patients their left and right ovary will be randomly
        allocated into the 0.42 ml/sec or 0.62 ml/sec flow rate group. Randomisation with
        minimisation will be employed.
  
        The specific flow rates will be achieved by adjusting the aspiration pressure of the vacuum
        pump accordingly. A study nurse will be responsible for adjusting the aspiration pressure of
        the vacuum pump depending on randomization. The doctor performing the oocyte retrieval will
        not be aware of the flow rate used in each ovary.
  
        All follicles will be aspirated and then flushed if needed up to a maximum of 5 times with an
        open flushing technique, using a 17G double-lumen needle.
  
        Data will be registered regarding the number of flushes required to retrieve a COC, the
        morphology of oocytes after denudation, oocyte fertilisation and embryo development up to the
        blastocyst stage.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of oocytes retrieved
  time frame: During oocyte retrieval
  description: Number of oocytes retrieved per ovary randomised.
  measure: Oocyte recovery rate
  time frame: During oocyte retrieval
  description: Number of oocytes retrieved per follicle aspirated.
  measure: Oocyte maturation rate
  time frame: 2-3 hours post oocyte retrieval
  description: Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised.
  measure: Average oocyte score
  time frame: 2-3 hours post oocyte retrieval
  description: Average oocyte score based on the evaluation of oocyte shape and size, ooplasm characteristics, structure of perivitelline space, structure of zona pellucida and polar body morphology.
  measure: Fertilization rate
  time frame: Day 1 post oocyte retrieval
  description: Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised.
  measure: Percentage of good quality blastocysts on day 5
  time frame: 5 days post oocyte retrieval
  description: Number of good quality blastocysts divided by the number of fertilized oocytes per ovary randomised.
  arm group label: Low aspiration flow rate
  arm group type: Experimental
  description: All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec.
  arm group label: High aspiration flow rate
  arm group type: Experimental
  description: All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec.
  intervention type: Procedure
  intervention name: Oocyte retrieval with low aspiration flow rate
  description: All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.42 ml/sec.
  arm group label: Low aspiration flow rate
  intervention type: Procedure
  intervention name: Oocyte retrieval with high aspiration flow rate
  description: High aspiration flow rate All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.62 ml/sec.
  arm group label: High aspiration flow rate
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Participants must have both ovaries present
  minimum age: 18 Years
  maximum age: 43 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: George T Lainas, PhD
  role: Principal Investigator
  affiliation: Eugonia ART Unit
  last name: George T Lainas, PhD
  phone: +302107236333
  email: ggslns@gmail.com
  last name: Tryfon G Lainas, PhD
  phone: +302107236333
  email: tlainas@eugonia.com.gr
  facility: 
  country: Greece
  citation: Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.
  PMID: 26630267
  responsible party type: Sponsor
  mesh term: Infertility
  sharing ipd: No