<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/NCT03799107</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 16-20474</org_study_id>
    <nct_id>NCT03799107</nct_id>
  </id_info>
  <brief_title>Developmental Epidemiological Study of Children Born Through Reproductive Technology</brief_title>
  <acronym>DESCRT</acronym>
  <official_title>The Developmental Epidemiological Study of Children Born Through Reproductive Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</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>
      DESCRT will be a long-term study that both looks back in time, at successful pregnancies, and&#xD;
      forward in time at early pregnancy and long-term as these children grow. Currently, there are&#xD;
      limited data on the long-term effects of infertility and infertility treatments on children.&#xD;
      There are some studies to suggest that these children may have altered metabolic profiles,&#xD;
      but this study aims to be the largest study to answer this question.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over the past 30 years, much of the research and clinical effort in the field of ART had to&#xD;
      do with improving outcome in terms of successful pregnancy. However, as these rates have&#xD;
      increased, attention is slowly turning to focus on the health of the resultant child.&#xD;
      Short-term health complications, in particular birth defects,have been well-described.&#xD;
      However, even this &quot;hard&quot; outcome has been difficult to characterize as studies used&#xD;
      different methodologies, varied age of detection, and frequently didn't have an appropriate&#xD;
      comparison group. When underlying parental factors and infertility are included in the&#xD;
      analyses, the association is substantially weakened or disappears completely. This&#xD;
      exemplifies the problems with much of the currently available research regarding childhood&#xD;
      outcomes following ART. While the health of children born through these technologies is of&#xD;
      critical public health interest, and of personal interest to families, only limited data&#xD;
      exist.&#xD;
&#xD;
      In order to evaluate the potential risk to long-term health of children conceived through&#xD;
      assisted reproductive technologies (ART) and non-IVF fertility treatments (NIFT), rigorous&#xD;
      epidemiological methods, appropriate characterization of the exposure, standardized&#xD;
      collection of outcome data, and appropriate comparison groups are required. The proposed&#xD;
      Developmental Epidemiological Study of Children born through Reproductive Technology (DESCRT)&#xD;
      is aimed to carefully address these important characteristics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 14, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic testing of child - fasting glucose</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>Fasting glucose mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic testing of child - fasting insulin</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>Fasting insulin uIU/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic testing of child - uric acid</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>uric acid mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic testing of child - total cholesterol</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>Cholesterol, Total mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic testing of child - HDL cholesterol</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>HDL cholesterol mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic testing of child - LDL cholesterol</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>LDL cholesterol mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic testing of child - Triglycerides</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>Triglycerides mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic testing of child - cholesterol ratio</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>CHOL/HDLC ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic testing of child - non-HDL cholesterol</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>Non-HDL cholesterol mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic testing of child - Alanine Aminotransferase</measure>
    <time_frame>1 day at study visit</time_frame>
    <description>Alanine Aminotransferase (ALT) U/L</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">3700</enrollment>
  <condition>Infertility</condition>
  <condition>Infertility, Female</condition>
  <condition>Infertility, Male</condition>
  <condition>Infertility Primary</condition>
  <condition>Infertility Secondary</condition>
  <condition>Infertility Unexplained</condition>
  <arm_group>
    <arm_group_label>Retrospective</arm_group_label>
    <description>Children born with assistance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prospective</arm_group_label>
    <description>People who have sought evaluation/treatment for infertility</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective:&#xD;
&#xD;
        - children conceived by parent(s) who sought evaluation/treatment for infertility&#xD;
&#xD;
        Prospective:&#xD;
&#xD;
        - people seeking evaluation/treatment for infertility&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Retrospective arm&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        - children conceived by parent(s) who sought evaluation/treatment for infertility&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Children with chronic medical illnesses that prevent a study visit&#xD;
&#xD;
        Prospective arm&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        - seeking evaluation/treatment for infertility&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
    <mesh_term>Infertility, Male</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/NCT03799107
org study id: IRB 16-20474
nct id: NCT03799107
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
DESCRT will be a long-term study that both looks back in time, at successful pregnancies, and
      forward in time at early pregnancy and long-term as these children grow. Currently, there are
      limited data on the long-term effects of infertility and infertility treatments on children.
      There are some studies to suggest that these children may have altered metabolic profiles,
      but this study aims to be the largest study to answer this question.
Over the past 30 years, much of the research and clinical effort in the field of ART had to
      do with improving outcome in terms of successful pregnancy. However, as these rates have
      increased, attention is slowly turning to focus on the health of the resultant child.
      Short-term health complications, in particular birth defects,have been well-described.
      However, even this "hard" outcome has been difficult to characterize as studies used
      different methodologies, varied age of detection, and frequently didn't have an appropriate
      comparison group. When underlying parental factors and infertility are included in the
      analyses, the association is substantially weakened or disappears completely. This
      exemplifies the problems with much of the currently available research regarding childhood
      outcomes following ART. While the health of children born through these technologies is of
      critical public health interest, and of personal interest to families, only limited data
      exist.

      In order to evaluate the potential risk to long-term health of children conceived through
      assisted reproductive technologies (ART) and non-IVF fertility treatments (NIFT), rigorous
      epidemiological methods, appropriate characterization of the exposure, standardized
      collection of outcome data, and appropriate comparison groups are required. The proposed
      Developmental Epidemiological Study of Children born through Reproductive Technology (DESCRT)
      is aimed to carefully address these important characteristics.
observational model: Cohort
time perspective: Other
measure: Metabolic testing of child - fasting glucose
time frame: 1 day at study visit
description: Fasting glucose mg/dL
measure: Metabolic testing of child - fasting insulin
time frame: 1 day at study visit
description: Fasting insulin uIU/mL
measure: Metabolic testing of child - uric acid
time frame: 1 day at study visit
description: uric acid mg/dL
measure: Metabolic testing of child - total cholesterol
time frame: 1 day at study visit
description: Cholesterol, Total mg/dL
measure: Metabolic testing of child - HDL cholesterol
time frame: 1 day at study visit
description: HDL cholesterol mg/dL
measure: Metabolic testing of child - LDL cholesterol
time frame: 1 day at study visit
description: LDL cholesterol mg/dL
measure: Metabolic testing of child - Triglycerides
time frame: 1 day at study visit
description: Triglycerides mg/dL
measure: Metabolic testing of child - cholesterol ratio
time frame: 1 day at study visit
description: CHOL/HDLC ratio
measure: Metabolic testing of child - non-HDL cholesterol
time frame: 1 day at study visit
description: Non-HDL cholesterol mg/dL
measure: Metabolic testing of child - Alanine Aminotransferase
time frame: 1 day at study visit
description: Alanine Aminotransferase (ALT) U/L
arm group label: Retrospective
description: Children born with assistance
arm group label: Prospective
description: People who have sought evaluation/treatment for infertility
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Infertility, Male