<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/NCT03831542</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03831542</nct_id>
  </id_info>
  <brief_title>Effect of Follicular Flushing in Patients With Mono-follicular Growth Undergoing In Vitro Fertilization</brief_title>
  <official_title>Follicular Flushing in Patients With Mono-follicular Growth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centrum Clinic IVF Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centrum Clinic IVF Center</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>
      Retrieval of an oocyte from a follicle relies on the release of the cumulus-oocyte-complex&#xD;
      (COC) from the follicular wall into the lumen, thereby allowing aspiration by a needle.&#xD;
      Flushing the follicle with multiple aspirations from the same follicle is used as a means to&#xD;
      increase the ratio of COC per aspirated follicle. Data showed that follicular flushing is not&#xD;
      superior to direct aspiration either in normally responding patients or in poor responders&#xD;
      undergoing in vitro fertilization (IVF). There is no data in the literature regarding the&#xD;
      issue in patients with mono-follicular growth. Direct aspiration or repeatedly flushing the&#xD;
      follicle for those with a single follicle will be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oocyte retrieval procedure This study aims to evaluate the effect of follicular flushing&#xD;
      during oocyte retrieval procedure in patients with only one follicle. Double lumen needle&#xD;
      will be used and direct follicular aspiration without flushing will be performed for all&#xD;
      patients. If an oocyte will be obtained, the patient will be assigned to group A. If not, at&#xD;
      least 1 course of follicular flushing will be used until retrieval of an oocyte and the&#xD;
      patient will be assigned to group B.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Actual">May 6, 2019</completion_date>
  <primary_completion_date type="Actual">May 5, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mature oocyte</measure>
    <time_frame>during oocyte retrieval procedure</time_frame>
    <description>Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fertilization rate after micro-injection</measure>
    <time_frame>24 hours after microinjection procedure</time_frame>
    <description>Confirmation of pronuclei formation on the following day of microinjection by a senior embryologist in each patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical pregnancy rate per embryo transfer</measure>
    <time_frame>untill 6 weeks</time_frame>
    <description>Confirmation of fetal cardiac activity on 5th or 6th week of gestation by a senior obstetrician in each pregnancy case.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">71</enrollment>
  <condition>Invitro Fertilization</condition>
  <condition>Diminished Ovarian Reserve</condition>
  <condition>Oocyte</condition>
  <arm_group>
    <arm_group_label>direct aspiration group</arm_group_label>
    <description>Transvaginal ultrasound-guided oocyte retrieval was performed 36 hours after ovulation trigger. A 17-gauge double lumen needle will be used to aspirate a single follicle without flushing. If an oocyte is obtained, the subject will be assigned to group 1. If not, operator will proceed with follicular flushing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>flushing group</arm_group_label>
    <description>If an oocyte is not obtained with direct aspiration, operator will proceed to follicular flushing and the subject will be assigned to group 2 if an oocyte is obtained following follicular flushing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>direct follicular aspiration</intervention_name>
    <description>direct follicular aspiration</description>
    <arm_group_label>direct aspiration group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>follicular flushing</intervention_name>
    <description>follicular flushing</description>
    <arm_group_label>flushing group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing oocyte retrieval procedure due to primary infertility&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women aged 18-40 years&#xD;
&#xD;
          -  primary infertility&#xD;
&#xD;
          -  diminished ovarian reserve with single mature follicle on the day of oocyte retrieval&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  natural cycle IVF&#xD;
&#xD;
          -  presence of endometriosis/endometrioma(s)&#xD;
&#xD;
          -  Absence of cumulus oocyte complex following oocyte retrieval&#xD;
&#xD;
          -  Severe male factor infertility&#xD;
&#xD;
          -  Pre-implantation genetic screening cycles&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emre Pabuccu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Centrum Clinic IVF Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centrum Clinic IVF Center</name>
      <address>
        <city>Ankara</city>
        <zip>06700</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>von Horn K, Depenbusch M, Schultze-Mosgau A, Griesinger G. Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response. Hum Reprod. 2017 Apr 1;32(4):832-835. doi: 10.1093/humrep/dex019.</citation>
    <PMID>28333185</PMID>
  </reference>
  <results_reference>
    <citation>Haydardedeoglu B, Gjemalaj F, Aytac PC, Kilicdag EB. Direct aspiration versus follicular flushing in poor responders undergoing intracytoplasmic sperm injection: a randomised controlled trial. BJOG. 2017 Jul;124(8):1190-1196. doi: 10.1111/1471-0528.14629. Epub 2017 May 2.</citation>
    <PMID>28276148</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 6, 2019</last_update_submitted>
  <last_update_submitted_qc>May 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centrum Clinic IVF Center</investigator_affiliation>
    <investigator_full_name>Emre Göksan Pabuçcu</investigator_full_name>
    <investigator_title>Emre G. Pabuccu, Assoc. Prof.</investigator_title>
  </responsible_party>
  <keyword>follicular flushing</keyword>
  <keyword>double lumen needle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flushing</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/NCT03831542
org study id: 1
nct id: NCT03831542
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrieval of an oocyte from a follicle relies on the release of the cumulus-oocyte-complex
      (COC) from the follicular wall into the lumen, thereby allowing aspiration by a needle.
      Flushing the follicle with multiple aspirations from the same follicle is used as a means to
      increase the ratio of COC per aspirated follicle. Data showed that follicular flushing is not
      superior to direct aspiration either in normally responding patients or in poor responders
      undergoing in vitro fertilization (IVF). There is no data in the literature regarding the
      issue in patients with mono-follicular growth. Direct aspiration or repeatedly flushing the
      follicle for those with a single follicle will be investigated.
Oocyte retrieval procedure This study aims to evaluate the effect of follicular flushing
      during oocyte retrieval procedure in patients with only one follicle. Double lumen needle
      will be used and direct follicular aspiration without flushing will be performed for all
      patients. If an oocyte will be obtained, the patient will be assigned to group A. If not, at
      least 1 course of follicular flushing will be used until retrieval of an oocyte and the
      patient will be assigned to group B.
observational model: Case-Control
time perspective: Prospective
measure: mature oocyte
time frame: during oocyte retrieval procedure
description: Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient.
measure: fertilization rate after micro-injection
time frame: 24 hours after microinjection procedure
description: Confirmation of pronuclei formation on the following day of microinjection by a senior embryologist in each patient.
measure: clinical pregnancy rate per embryo transfer
time frame: untill 6 weeks
description: Confirmation of fetal cardiac activity on 5th or 6th week of gestation by a senior obstetrician in each pregnancy case.
arm group label: direct aspiration group
description: Transvaginal ultrasound-guided oocyte retrieval was performed 36 hours after ovulation trigger. A 17-gauge double lumen needle will be used to aspirate a single follicle without flushing. If an oocyte is obtained, the subject will be assigned to group 1. If not, operator will proceed with follicular flushing.
arm group label: flushing group
description: If an oocyte is not obtained with direct aspiration, operator will proceed to follicular flushing and the subject will be assigned to group 2 if an oocyte is obtained following follicular flushing.
intervention type: Behavioral
intervention name: direct follicular aspiration
description: direct follicular aspiration
arm group label: direct aspiration group
intervention type: Behavioral
intervention name: follicular flushing
description: follicular flushing
arm group label: flushing group
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emre Pabuccu, MD
role: Study Director
affiliation: Centrum Clinic IVF Center
facility: 
country: Turkey
citation: von Horn K, Depenbusch M, Schultze-Mosgau A, Griesinger G. Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response. Hum Reprod. 2017 Apr 1;32(4):832-835. doi: 10.1093/humrep/dex019.
PMID: 28333185
citation: Haydardedeoglu B, Gjemalaj F, Aytac PC, Kilicdag EB. Direct aspiration versus follicular flushing in poor responders undergoing intracytoplasmic sperm injection: a randomised controlled trial. BJOG. 2017 Jul;124(8):1190-1196. doi: 10.1111/1471-0528.14629. Epub 2017 May 2.
PMID: 28276148
responsible party type: Principal Investigator
investigator affiliation: Centrum Clinic IVF Center
investigator full name: Emre Göksan Pabuçcu
investigator title: Emre G. Pabuccu, Assoc. Prof.
mesh term: Flushing