<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/NCT03809338</url>
  </required_header>
  <id_info>
    <org_study_id>AcibademFulyaH</org_study_id>
    <nct_id>NCT03809338</nct_id>
  </id_info>
  <brief_title>Ovarian Functions in Flight Attendants</brief_title>
  <official_title>Evaluation of Antral Follicle Count and Amh Values in Women Working at Night and Flight Attendants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem Fulya Hastanesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acibadem Fulya Hastanesi</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness,&#xD;
      excessive hours spent on flight and UV radiation exposure over ovarian function in flight&#xD;
      attendant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness,&#xD;
      excessive hours spent on flight and UV radiation exposure over ovarian function in flight&#xD;
      attendant women.&#xD;
&#xD;
      On the third day of the menstrual period, evaluate the number of antral follicle count will&#xD;
      be examined and the level of hormones showing the ovarian functions will be measured in the&#xD;
      blood sample given by the participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>level of amh</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Ovarian Functions in Flight Attendants</condition>
  <arm_group>
    <arm_group_label>flight attendant women</arm_group_label>
    <description>Assesment antral follicle count on day 3 5ml blood sample to be taken</description>
  </arm_group>
  <arm_group>
    <arm_group_label>day working women</arm_group_label>
    <description>Assesment antral follicle count on day 3 5ml blood sample to be taken</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>amh test</intervention_name>
    <description>Antral follicle count with ultrasound on the 3rd day of menstruation</description>
    <arm_group_label>day working women</arm_group_label>
    <arm_group_label>flight attendant women</arm_group_label>
    <other_name>Day 3 antral follicle with transvaginal ultrasonography</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      5 ml blood sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        50 flight attendants and 50 control patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  day working women , 25-35 years old&#xD;
&#xD;
          -  night working women , 25-35 years old&#xD;
&#xD;
          -  flight attendant women, 25-35 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those who cannot enter the groups above&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>evaluation ovarian functions of women</gender_description>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>ercan bastu, 1</last_name>
    <phone>+905324134195</phone>
    <email>ercanbastu@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>yucel kocyigit, 2</last_name>
    <phone>+905057006643</phone>
    <email>yucelkocyigit@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Acibadem Fulya Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ercan Bastu, MSc, MD</last_name>
      <email>ercanbastu@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Ercan Bastu, MSc, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>August 16, 2019</last_update_submitted>
  <last_update_submitted_qc>August 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03809338
org study id: AcibademFulyaH
nct id: NCT03809338
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness,
      excessive hours spent on flight and UV radiation exposure over ovarian function in flight
      attendant women.
The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness,
      excessive hours spent on flight and UV radiation exposure over ovarian function in flight
      attendant women.

      On the third day of the menstrual period, evaluate the number of antral follicle count will
      be examined and the level of hormones showing the ovarian functions will be measured in the
      blood sample given by the participant.
observational model: Cohort
time perspective: Cross-Sectional
measure: level of amh
time frame: one year
arm group label: flight attendant women
description: Assesment antral follicle count on day 3 5ml blood sample to be taken
arm group label: day working women
description: Assesment antral follicle count on day 3 5ml blood sample to be taken
intervention type: Diagnostic Test
intervention name: amh test
description: Antral follicle count with ultrasound on the 3rd day of menstruation
arm group label: day working women
arm group label: flight attendant women
other name: Day 3 antral follicle with transvaginal ultrasonography
5 ml blood sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: evaluation ovarian functions of women
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ercan bastu, 1
phone: +905324134195
email: ercanbastu@gmail.com
last name: yucel kocyigit, 2
phone: +905057006643
email: yucelkocyigit@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
responsible party type: Sponsor
sharing ipd: No