<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/NCT02995343</url>
  </required_header>
  <id_info>
    <org_study_id>2.100.2014.0076</org_study_id>
    <nct_id>NCT02995343</nct_id>
  </id_info>
  <brief_title>Evaluation of the Ovarian Reserve in Patients Who Hypogastric Arteries and or Uterine Arteries Had Been Ligated</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege University</source>
  <brief_summary>
    <textblock>
      Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated&#xD;
      in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes,&#xD;
      antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will&#xD;
      search their archives for finding suitable patients for study. Investigators will especially&#xD;
      notice being at least 6 month time of interval between surgery and evaluation time.&#xD;
      Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of&#xD;
      menstrual cycle. These results will be compared with normal postpartum women's results. It&#xD;
      will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine&#xD;
      arteries on ovarian reserve&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anti-mullerian hormone levels will be evaluated</measure>
    <time_frame>6 months after surgery and delivery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Antral Follicule Count will be evaluated</measure>
    <time_frame>6 months after surgery and delivery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ovarian volume will be evaluated</measure>
    <time_frame>6 months after surgery and delivery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Follicule Stimuli Hormone levels will be evaluated</measure>
    <time_frame>6 months after surgery and delivery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Estrogen levels will be evaluated</measure>
    <time_frame>6 months after surgery and delivery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Ovarian Reserve</condition>
  <condition>Hypogastric Artery Ligation</condition>
  <condition>Uterine Artery Ligation</condition>
  <arm_group>
    <arm_group_label>Hypogastric and/or uterine artery ligation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who had been ligated hypogastric artery and or uterine artery for ceasing uterine bleeding during c-section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal postpartum women</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hypogastric and/or uterine artery ligation</intervention_name>
    <arm_group_label>Hypogastric and/or uterine artery ligation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients had been ligated hypogastric and/or uterine arteries&#xD;
&#xD;
          -  Patients are in 6 month period after surgery&#xD;
&#xD;
          -  Without performed hysterectomy&#xD;
&#xD;
          -  No older than 40 years old&#xD;
&#xD;
          -  No history about endocrinopathy which have an effect upon ovarian reserve&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients had been made other gynecologic surgery such as fallopian tube ligation and&#xD;
             hysterectomy etc.&#xD;
&#xD;
          -  Patients are older than 40 years old&#xD;
&#xD;
          -  Patients use drugs which have an effect upon ovarian reserve&#xD;
&#xD;
          -  Patients have diseases which have an effect upon ovarian reserve such as some&#xD;
             endocrinopathy, malign diseases which require radiotherapy and chemotherapy etc.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>cagdas sahin, MD</last_name>
    <phone>+905324676106</phone>
    <email>cagdasdr@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ege University, Medicine Faculty, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>cagdas sahin, MD</last_name>
      <phone>+905324676106</phone>
      <email>cagdasdr@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Cagdas Sahin</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT02995343
org study id: 2.100.2014.0076
nct id: NCT02995343
lead sponsor: 
Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated
      in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes,
      antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will
      search their archives for finding suitable patients for study. Investigators will especially
      notice being at least 6 month time of interval between surgery and evaluation time.
      Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of
      menstrual cycle. These results will be compared with normal postpartum women's results. It
      will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine
      arteries on ovarian reserve
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Anti-mullerian hormone levels will be evaluated
time frame: 6 months after surgery and delivery
measure: Antral Follicule Count will be evaluated
time frame: 6 months after surgery and delivery
measure: Ovarian volume will be evaluated
time frame: 6 months after surgery and delivery
measure: Follicule Stimuli Hormone levels will be evaluated
time frame: 6 months after surgery and delivery
measure: Estrogen levels will be evaluated
time frame: 6 months after surgery and delivery
arm group label: Hypogastric and/or uterine artery ligation
arm group type: Experimental
description: Patients who had been ligated hypogastric artery and or uterine artery for ceasing uterine bleeding during c-section
arm group label: Normal postpartum women
arm group type: No Intervention
intervention type: Procedure
intervention name: Hypogastric and/or uterine artery ligation
arm group label: Hypogastric and/or uterine artery ligation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: cagdas sahin, MD
phone: +905324676106
email: cagdasdr@yahoo.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Cagdas Sahin
investigator title: MD