<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/NCT03778684</url>
  </required_header>
  <id_info>
    <org_study_id>ICSI-Alaa</org_study_id>
    <nct_id>NCT03778684</nct_id>
  </id_info>
  <brief_title>Obesity and Intracytoplasmic Sperm Injection Cycle Outcome</brief_title>
  <official_title>Impact of Obesity on Intracytoplasmic Sperm Injection Cycle Outcome: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Obesity has been associated with menstrual irregularities, chronic an-ovulation, infertility,&#xD;
      and poor outcomes in women undergoing in vitro fertilization.&#xD;
&#xD;
      There is strong evidence that obesity is associated with a higher n vitro fertilization cycle&#xD;
      cancellation rate (despite administration of higher doses of exogenous gonadotrophins), a&#xD;
      lower mature oocyte yield and lower number of cryopreservation cycles.&#xD;
&#xD;
      Furthermore, obese women have been shown to have impaired response to ovarian stimulation and&#xD;
      significantly lower live births after in vitro fertilization. Indeed, obesity affects many&#xD;
      ovarian intra-follicular steroidogenic, metabolic and inflammatory pathways.This is&#xD;
      particularly evident in women with abdominal (central obesity). Waist circumference&#xD;
      measurement is used to identify individuals with abdominal obesity but it cannot&#xD;
      differentiate between intra-abdominal fat and subcutaneous abdominal fat accumulation.&#xD;
&#xD;
      The reliable measurement of visceral fat and subcutaneous fat is not only important as a tool&#xD;
      to predict cardiovascular and metabolic disease risk, but it is also essential to evaluate&#xD;
      the effect of these fat compartments on female reproductive function. Intra-abdominal fat&#xD;
      accumulation is related to insulin resistance in women with polycystic ovary syndrome and in&#xD;
      these women the resulting hyperinsulinemia contributes to an-ovulation.&#xD;
&#xD;
      Obese anovulatory women with polycystic ovary syndrome who resume ovulation during a 6-month&#xD;
      lifestyle program lose more visceral fat with no difference in the change of subcutaneous fat&#xD;
      compared to the women who did not resume ovulation.&#xD;
&#xD;
      Another recent study that enrolled 140 non-polycystic ovary syndrome in vitro fertilization&#xD;
      women demonstrated that women with increased waist circumference and higher follicular fluid&#xD;
      leptin have less oocytes fertilized and failed in vitro fertilization outcomes. Increased&#xD;
      intra-abdominal fat during early pregnancy is associated with insulin resistance and&#xD;
      increased diastolic blood pressure and it can predict glucose intolerance in later pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">November 26, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of women will be pregnant (clinical pregnancy rate)</measure>
    <time_frame>1 month</time_frame>
    <description>a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Normal Body mass index without central obesity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High Body mass index with central obesity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Visceral fat thickness</intervention_name>
    <description>An initial longitudinal sweep will be done from the xiphoid process to the umbilicus to determine the area of maximum pre-peritoneal fat thickness.</description>
    <arm_group_label>High Body mass index with central obesity</arm_group_label>
    <arm_group_label>Normal Body mass index without central obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Body mass index</intervention_name>
    <description>Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.</description>
    <arm_group_label>High Body mass index with central obesity</arm_group_label>
    <arm_group_label>Normal Body mass index without central obesity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of women 18 - 35 yrs old.&#xD;
&#xD;
          -  Women with Body mass index I 18 - 35 kg/m2.&#xD;
&#xD;
          -  Infertile women with an indication for In vitro fertilization&#xD;
&#xD;
          -  Anticipated normal responders.&#xD;
&#xD;
          -  Normal uterine cavity by trans-vaginal ultrasound.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poly cystic ovarian syndrome&#xD;
&#xD;
          -  Diabetic patients.&#xD;
&#xD;
          -  Known Poor ovarian response&#xD;
&#xD;
          -  Patients with abnormal uterine cavity.&#xD;
&#xD;
          -  Refusal to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>November 26, 2022</last_update_submitted>
  <last_update_submitted_qc>November 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Alaa Ahmad Mohamed Makhlouf</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03778684
org study id: ICSI-Alaa
nct id: NCT03778684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity has been associated with menstrual irregularities, chronic an-ovulation, infertility,
      and poor outcomes in women undergoing in vitro fertilization.

      There is strong evidence that obesity is associated with a higher n vitro fertilization cycle
      cancellation rate (despite administration of higher doses of exogenous gonadotrophins), a
      lower mature oocyte yield and lower number of cryopreservation cycles.

      Furthermore, obese women have been shown to have impaired response to ovarian stimulation and
      significantly lower live births after in vitro fertilization. Indeed, obesity affects many
      ovarian intra-follicular steroidogenic, metabolic and inflammatory pathways.This is
      particularly evident in women with abdominal (central obesity). Waist circumference
      measurement is used to identify individuals with abdominal obesity but it cannot
      differentiate between intra-abdominal fat and subcutaneous abdominal fat accumulation.

      The reliable measurement of visceral fat and subcutaneous fat is not only important as a tool
      to predict cardiovascular and metabolic disease risk, but it is also essential to evaluate
      the effect of these fat compartments on female reproductive function. Intra-abdominal fat
      accumulation is related to insulin resistance in women with polycystic ovary syndrome and in
      these women the resulting hyperinsulinemia contributes to an-ovulation.

      Obese anovulatory women with polycystic ovary syndrome who resume ovulation during a 6-month
      lifestyle program lose more visceral fat with no difference in the change of subcutaneous fat
      compared to the women who did not resume ovulation.

      Another recent study that enrolled 140 non-polycystic ovary syndrome in vitro fertilization
      women demonstrated that women with increased waist circumference and higher follicular fluid
      leptin have less oocytes fertilized and failed in vitro fertilization outcomes. Increased
      intra-abdominal fat during early pregnancy is associated with insulin resistance and
      increased diastolic blood pressure and it can predict glucose intolerance in later pregnancy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of women will be pregnant (clinical pregnancy rate)
time frame: 1 month
description: a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy.
arm group label: Normal Body mass index without central obesity
arm group type: Experimental
arm group label: High Body mass index with central obesity
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Visceral fat thickness
description: An initial longitudinal sweep will be done from the xiphoid process to the umbilicus to determine the area of maximum pre-peritoneal fat thickness.
arm group label: High Body mass index with central obesity
arm group label: Normal Body mass index without central obesity
intervention type: Diagnostic Test
intervention name: Body mass index
description: Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.
arm group label: High Body mass index with central obesity
arm group label: Normal Body mass index without central obesity
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Alaa Ahmad Mohamed Makhlouf
investigator title: Assistant Lecturer
mesh term: Infertility
sharing ipd: Undecided