<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/NCT02999555</url>
  </required_header>
  <id_info>
    <org_study_id>MMC160192-16CTIL</org_study_id>
    <nct_id>NCT02999555</nct_id>
  </id_info>
  <brief_title>Novel Evaluation of Aspirated Follicular Fluid</brief_title>
  <official_title>Presence and Quantification of Inflammatory Cytokines, Dendritic Cells, Vasorin and Soluble Flt1 in Aspirated Follicular Fluid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weizmann Institute of Science</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Meir Medical 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>
      A molecular study of follicular fluid aspirated from ovarian follicles during routine in&#xD;
      vitro fertilization treatment, after the eggs were identified and separated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian stimulation is a routine part of in vitro fertilization treatment: this process&#xD;
      involves an inflammatory response in the developing follicles. We still do not completely&#xD;
      understand the complex interactions leading to the maturation of the egg and the multiple&#xD;
      interactions of the egg with its supporting cells. In this study we will assess follicular&#xD;
      fluid, letf over after the eggs were identified and separated, for the presence of&#xD;
      inflammatory mediators, dendritic cells , vasorin and soluble Flt1. The presence and&#xD;
      quantification of these factors, as well as their correlation with the size of the aspirated&#xD;
      follicle is the focus of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Soluble Vasorin levels</measure>
    <time_frame>24 hours post egg retrieval</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Soluble Flt 1 levels</measure>
    <time_frame>24 hours post egg retrieval</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dendritic cells quantification</measure>
    <time_frame>24 hours post egg retrieval</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ovary Inflammation</condition>
  <arm_group>
    <arm_group_label>Aspirated follicular fluid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Follicular fluid aspirated by follicle size and tested for the novel markers after eggs were identified and separated for the purpose of fertilization</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ovum pickup</intervention_name>
    <description>Ovum pickup or Egg retrieval, that is performed not for the purpose of the study, but for the purpose of well known in vitro fertilization indications</description>
    <arm_group_label>Aspirated follicular fluid</arm_group_label>
    <other_name>Egg retrieval</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women going through a fertility/ fertility preservation indicated egg retrieval in&#xD;
             the in vitro fertilization (IVF) unit in 'Meir medical center',&#xD;
&#xD;
          -  Patients' informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusing to take part in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MEIR medical center REB committee REB committee</last_name>
    <role>Study Chair</role>
    <affiliation>Tel Aviv University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anat Hershko Klement, MD</last_name>
    <phone>972549170084</phone>
    <email>anat.klement@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anat Hershko Klement, MD</last_name>
      <phone>972549170084</phone>
      <email>anat.klement@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Wulff C, Wiegand SJ, Saunders PT, Scobie GA, Fraser HM. Angiogenesis during follicular development in the primate and its inhibition by treatment with truncated Flt-1-Fc (vascular endothelial growth factor Trap(A40)). Endocrinology. 2001 Jul;142(7):3244-54. doi: 10.1210/endo.142.7.8258.</citation>
    <PMID>11416048</PMID>
  </reference>
  <reference>
    <citation>Gruemmer R, Motejlek K, Berghaus D, Weich HA, Neulen J. Regulation of soluble vascular endothelial growth factor receptor (sFlt-1/sVEGFR-1) expression and release in endothelial cells by human follicular fluid and granulosa cells. Reprod Biol Endocrinol. 2005 Oct 25;3:57. doi: 10.1186/1477-7827-3-57.</citation>
    <PMID>16248895</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>Anat Hershko Klement</investigator_full_name>
    <investigator_title>Dr Anat Hershko Klement</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</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/NCT02999555
org study id: MMC160192-16CTIL
nct id: NCT02999555
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A molecular study of follicular fluid aspirated from ovarian follicles during routine in
      vitro fertilization treatment, after the eggs were identified and separated.
Ovarian stimulation is a routine part of in vitro fertilization treatment: this process
      involves an inflammatory response in the developing follicles. We still do not completely
      understand the complex interactions leading to the maturation of the egg and the multiple
      interactions of the egg with its supporting cells. In this study we will assess follicular
      fluid, letf over after the eggs were identified and separated, for the presence of
      inflammatory mediators, dendritic cells , vasorin and soluble Flt1. The presence and
      quantification of these factors, as well as their correlation with the size of the aspirated
      follicle is the focus of this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Soluble Vasorin levels
time frame: 24 hours post egg retrieval
measure: Soluble Flt 1 levels
time frame: 24 hours post egg retrieval
measure: Dendritic cells quantification
time frame: 24 hours post egg retrieval
arm group label: Aspirated follicular fluid
arm group type: Experimental
description: Follicular fluid aspirated by follicle size and tested for the novel markers after eggs were identified and separated for the purpose of fertilization
intervention type: Procedure
intervention name: Ovum pickup
description: Ovum pickup or Egg retrieval, that is performed not for the purpose of the study, but for the purpose of well known in vitro fertilization indications
arm group label: Aspirated follicular fluid
other name: Egg retrieval
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: MEIR medical center REB committee REB committee
role: Study Chair
affiliation: Tel Aviv University
last name: Anat Hershko Klement, MD
phone: 972549170084
email: anat.klement@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
citation: Wulff C, Wiegand SJ, Saunders PT, Scobie GA, Fraser HM. Angiogenesis during follicular development in the primate and its inhibition by treatment with truncated Flt-1-Fc (vascular endothelial growth factor Trap(A40)). Endocrinology. 2001 Jul;142(7):3244-54. doi: 10.1210/endo.142.7.8258.
PMID: 11416048
citation: Gruemmer R, Motejlek K, Berghaus D, Weich HA, Neulen J. Regulation of soluble vascular endothelial growth factor receptor (sFlt-1/sVEGFR-1) expression and release in endothelial cells by human follicular fluid and granulosa cells. Reprod Biol Endocrinol. 2005 Oct 25;3:57. doi: 10.1186/1477-7827-3-57.
PMID: 16248895
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: Anat Hershko Klement
investigator title: Dr Anat Hershko Klement
mesh term: Inflammation