<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/NCT02205866</url>
  </required_header>
  <id_info>
    <org_study_id>1403-VLC-012-JB</org_study_id>
    <nct_id>NCT02205866</nct_id>
  </id_info>
  <brief_title>Incidence of Non Receptive Endometrium in Obese Women</brief_title>
  <official_title>Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Valenciano de Infertilidad, IVI VALENCIA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Valenciano de Infertilidad, IVI VALENCIA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the incidence of Non Receptive endometrium in obese infertile women&#xD;
      compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test,&#xD;
      containing 238 genes, identifying the receptivity status of an endometrial sample and&#xD;
      diagnosing the patient's Window of Implantation, regardless of the histological appearance of&#xD;
      the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural&#xD;
      cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non Receptive Endometrium</measure>
    <time_frame>25 days</time_frame>
    <description>To evaluate the incidence of Not Receptive endometrium in obese infertile women compared to infertile normal weight women using an adequate sample size.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distribution of fat and risk factors</measure>
    <time_frame>4 months</time_frame>
    <description>Carry out a subanalysis concerning the distribution of central and peripheric fat and risk factors of metabolic syndrome including: Age (years); Height (m); Weight (kg) ; BMI (kg/m2); Waist (cm) ; Hip (cm); Index waist-hip ratio (WHR) waist (cm) / hip (cm); Blood pressure; insulinemia Fasting blood glucose (mmol / L); PTG ( tolerance oral glucose ) (mmol / L), Total cholesterol and fractions; Triglycerides Microalbuminuria; bA1C, HC-reactive protein.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Look for specific endometrial gene patterns.</measure>
    <time_frame>25 days</time_frame>
    <description>Find patterns of expression of specific genes in endometrial obese women: we will by analyzing the expression of 238 genes obtained after endometrial endometrial biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the result of assisted reproduction treatment.</measure>
    <time_frame>12 months</time_frame>
    <description>Relate if the displacement of the WOI induced by the obesity is clinically relevant after the personalized embryo transfer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non Obese patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Obese patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endometrial Receptivity Array analysis of endometrial biopsy</intervention_name>
    <description>A biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome.</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertile women: &gt; 1 year of regular unprotected intercourse without evidence of&#xD;
             pregnancy.&#xD;
&#xD;
          -  Normal uterus by 2D/3D ultrasound scan and/or hysteroscopy&#xD;
&#xD;
          -  No endometriosis&#xD;
&#xD;
          -  Presence of both ovaries&#xD;
&#xD;
          -  &lt; 45 years old (in ovum donation, outcome parameters are not affected until this age&#xD;
             in all the current published studies).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hydrosalpinx&#xD;
&#xD;
          -  Stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy.&#xD;
&#xD;
          -  Implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy)&#xD;
&#xD;
          -  Recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)&#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>Jose Bellver, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVI Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stamford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305-5101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVI Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>June 26, 2019</last_update_submitted>
  <last_update_submitted_qc>June 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Valenciano de Infertilidad, IVI VALENCIA</investigator_affiliation>
    <investigator_full_name>Jose Bellver</investigator_full_name>
    <investigator_title>Dr. Jose Bellver</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT02205866
org study id: 1403-VLC-012-JB
nct id: NCT02205866
lead sponsor: 
has dmc: No
This study evaluates the incidence of Non Receptive endometrium in obese infertile women
      compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test,
      containing 238 genes, identifying the receptivity status of an endometrial sample and
      diagnosing the patient's Window of Implantation, regardless of the histological appearance of
      the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural
      cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Non Receptive Endometrium
time frame: 25 days
description: To evaluate the incidence of Not Receptive endometrium in obese infertile women compared to infertile normal weight women using an adequate sample size.
measure: Distribution of fat and risk factors
time frame: 4 months
description: Carry out a subanalysis concerning the distribution of central and peripheric fat and risk factors of metabolic syndrome including: Age (years); Height (m); Weight (kg) ; BMI (kg/m2); Waist (cm) ; Hip (cm); Index waist-hip ratio (WHR) waist (cm) / hip (cm); Blood pressure; insulinemia Fasting blood glucose (mmol / L); PTG ( tolerance oral glucose ) (mmol / L), Total cholesterol and fractions; Triglycerides Microalbuminuria; bA1C, HC-reactive protein.
measure: Look for specific endometrial gene patterns.
time frame: 25 days
description: Find patterns of expression of specific genes in endometrial obese women: we will by analyzing the expression of 238 genes obtained after endometrial endometrial biopsy.
measure: Evaluate the result of assisted reproduction treatment.
time frame: 12 months
description: Relate if the displacement of the WOI induced by the obesity is clinically relevant after the personalized embryo transfer.
arm group label: Group A
arm group type: Active Comparator
description: Non Obese patients
arm group label: Group B
arm group type: Experimental
description: Obese patients
intervention type: Other
intervention name: Endometrial Receptivity Array analysis of endometrial biopsy
description: A biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome.
arm group label: Group A
arm group label: Group B
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Jose Bellver, MD PhD
role: Principal Investigator
affiliation: IVI Valencia
facility: 
facility: 
facility: 
country: Spain
country: United States
responsible party type: Principal Investigator
investigator affiliation: Instituto Valenciano de Infertilidad, IVI VALENCIA
investigator full name: Jose Bellver
investigator title: Dr. Jose Bellver
mesh term: Infertility