<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/NCT04479059</url>
  </required_header>
  <id_info>
    <org_study_id>Ebru Cogendez</org_study_id>
    <nct_id>NCT04479059</nct_id>
  </id_info>
  <brief_title>Endometrial Follicular Fluid Flushing and IVF Outcome</brief_title>
  <official_title>Endometrial Follicular Fluid Flushing and IVF Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zeynep Kamil Maternity and Pediatric Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zeynep Kamil Maternity and Pediatric Research and Training 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>
      Objective: In this study, our aim will be investigating the pregnancy results in unexplained&#xD;
      infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid,&#xD;
      that we maintain mature follicules inside them in oocyte retrieval day.&#xD;
&#xD;
      Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro&#xD;
      Fertilization Center between October 2016 to May 2017 will be randomized with computer&#xD;
      generated programme. The patients will be divided into two groups; follicular fluid group&#xD;
      (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal&#xD;
      FSH level &lt; 10 mIU/ml, body mass index&lt;35 kg/m2 and E2 levels in human chorionic gonadotropin&#xD;
      (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the&#xD;
      study programme. The exclusion criteria are determined as below: previously diagnosed&#xD;
      endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history&#xD;
      of implantation failure in IVF/ICSI cycles and severe male factor infertility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: In this study, our aim will be investigating the pregnancy results in unexplained&#xD;
      infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid,&#xD;
      that we maintain mature follicules inside them in oocyte retrieval day.&#xD;
&#xD;
      Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro&#xD;
      Fertilization Center between October 2016 to May 2017 will be randomized with computer&#xD;
      generated programme. The patients will be divided into two groups; follicular fluid group&#xD;
      (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal&#xD;
      FSH level &lt; 10 mIU/ml, body mass index&lt;35 kg/m2 and E2 levels in human chorionic gonadotropin&#xD;
      (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the&#xD;
      study programme. The exclusion criteria are determined as below: previously diagnosed&#xD;
      endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history&#xD;
      of implantation failure in IVF/ICSI cycles and severe male factor infertility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 30, 2017</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>Clinical pregnancy</measure>
    <time_frame>during last 24 months</time_frame>
    <description>intrauterine pregnancy with metal cardiac activity</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Clinical Pregnancy</condition>
  <arm_group>
    <arm_group_label>İntracavitary fluid flushing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>follicular fluid flushing</intervention_name>
    <description>Follicular fluid obtained during OPU will be used for endometrial cavity flushing.</description>
    <arm_group_label>İntracavitary fluid flushing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria:age between 20-39 years, basal FSH level &lt; 10 mIU/ml, body mass index&lt;35&#xD;
        kg/m2 and E2 levels in human chorionic gonadotropin (hCG) day between 1000-4000 pg/ml. -&#xD;
&#xD;
        Exclusion Criteria:previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx,&#xD;
        endocrinological disorders; previous history of implantation failure in IVF/ICSI cycles and&#xD;
        severe male factor infertility.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>infertile women</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 18, 2020</last_update_submitted>
  <last_update_submitted_qc>July 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zeynep Kamil Maternity and Pediatric Research and Training Hospital</investigator_affiliation>
    <investigator_full_name>Faik Uzun</investigator_full_name>
    <investigator_title>research assistant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flushing</mesh_term>
  </condition_browse>
  <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/NCT04479059
org study id: Ebru Cogendez
nct id: NCT04479059
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: In this study, our aim will be investigating the pregnancy results in unexplained
      infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid,
      that we maintain mature follicules inside them in oocyte retrieval day.

      Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro
      Fertilization Center between October 2016 to May 2017 will be randomized with computer
      generated programme. The patients will be divided into two groups; follicular fluid group
      (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal
      FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin
      (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the
      study programme. The exclusion criteria are determined as below: previously diagnosed
      endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history
      of implantation failure in IVF/ICSI cycles and severe male factor infertility.
Objective: In this study, our aim will be investigating the pregnancy results in unexplained
      infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid,
      that we maintain mature follicules inside them in oocyte retrieval day.

      Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro
      Fertilization Center between October 2016 to May 2017 will be randomized with computer
      generated programme. The patients will be divided into two groups; follicular fluid group
      (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal
      FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin
      (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the
      study programme. The exclusion criteria are determined as below: previously diagnosed
      endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history
      of implantation failure in IVF/ICSI cycles and severe male factor infertility.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical pregnancy
time frame: during last 24 months
description: intrauterine pregnancy with metal cardiac activity
arm group label: İntracavitary fluid flushing
arm group type: Experimental
arm group label: Control group
arm group type: No Intervention
intervention type: Other
intervention name: follicular fluid flushing
description: Follicular fluid obtained during OPU will be used for endometrial cavity flushing.
arm group label: İntracavitary fluid flushing
criteria: 
gender: Female
gender based: Yes
gender description: infertile women
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
investigator full name: Faik Uzun
investigator title: research assistant
mesh term: Flushing
sharing ipd: No