<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/NCT03274765</url>
  </required_header>
  <id_info>
    <org_study_id>35RC15_3019</org_study_id>
    <nct_id>NCT03274765</nct_id>
  </id_info>
  <brief_title>Improved Medically Assisted Procreation Monitoring</brief_title>
  <acronym>NGAMP</acronym>
  <official_title>Improved Medically Assisted Procreation (MAP) Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Patient care in Medically Assisted Procreation (MAP) requires a close and regular monitoring&#xD;
      of the evolution of the estradiol rate. This monitoring allows the dose and duration of&#xD;
      treatment to be accurately adjusted for each woman (every 24 or 48 hours) up to 10 to 15 days&#xD;
      of treatment with gonadotrophins. Oestradiol (E2) is secreted by the growing ovarian&#xD;
      follicles and reflects their growth and maturity. Its plasma dosage makes it possible to&#xD;
      monitor the ovarian response to stimulation.&#xD;
&#xD;
      This monitoring involves several constraints amongst which disruption of work life, stress,&#xD;
      fatigue that can alter the response to treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to improve the comfort of patients already under severe stress, simplification of&#xD;
      this monitoring is proposed. The development of an immediate-release whole blood test for&#xD;
      simplified monitoring of estradiol levels will provide considerable comfort in the management&#xD;
      of patients. These patients are subjected to significant emotional and physical stress and&#xD;
      the development of this test will reduce the negative consequences that result.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 15, 2017</start_date>
  <completion_date type="Anticipated">December 15, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of successful tests</measure>
    <time_frame>1 hour</time_frame>
    <description>Number of tests yieling a result (whatever the value)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>Through study completion, an average of 1 month</time_frame>
    <description>Rate of true positive test results (comparison with oestradiol level in blood sample, as gold standard)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity</measure>
    <time_frame>Through study completion, an average of 1 month</time_frame>
    <description>Rate of true negative test results (comparison with oestradiol level in blood sample, as gold standard)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Women with ovarian stimulation</arm_group_label>
    <description>Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring Dosage of oestradiol</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dosage of oestradiol</intervention_name>
    <description>The study is based on a concept using capillary blood tests using lateral flow by migration on membrane similarly to a pregnancy test, patented by a french company (NGBiotech).&#xD;
This study is therefore a feasibility study of a rapid test for oestradiol dosage during monitoring of ovarian stimulation.</description>
    <arm_group_label>Women with ovarian stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation&#xD;
        monitoring&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Women over 18 years old&#xD;
&#xD;
          -  Patient followed for monitoring of ovarian stimulation;&#xD;
&#xD;
          -  Having received information on the protocol and given consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adult under safeguard of justice, guardianship or curatorship&#xD;
&#xD;
          -  Persons deprived of liberty.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Celia RAVEL, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Celia RAVEL, MD, PhD</last_name>
    <phone>+3332 99 26 59 16</phone>
    <email>cela.ravel@chu-rennes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Celia RAVEL, MD, PhD</last_name>
      <email>celia.ravel@chu-rennes.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ovarian stimulation</keyword>
  <keyword>blood test</keyword>
  <keyword>Medically Assisted Procreation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol</mesh_term>
  </intervention_browse>
  <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/NCT03274765
org study id: 35RC15_3019
nct id: NCT03274765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patient care in Medically Assisted Procreation (MAP) requires a close and regular monitoring
      of the evolution of the estradiol rate. This monitoring allows the dose and duration of
      treatment to be accurately adjusted for each woman (every 24 or 48 hours) up to 10 to 15 days
      of treatment with gonadotrophins. Oestradiol (E2) is secreted by the growing ovarian
      follicles and reflects their growth and maturity. Its plasma dosage makes it possible to
      monitor the ovarian response to stimulation.

      This monitoring involves several constraints amongst which disruption of work life, stress,
      fatigue that can alter the response to treatment
In order to improve the comfort of patients already under severe stress, simplification of
      this monitoring is proposed. The development of an immediate-release whole blood test for
      simplified monitoring of estradiol levels will provide considerable comfort in the management
      of patients. These patients are subjected to significant emotional and physical stress and
      the development of this test will reduce the negative consequences that result.
observational model: Cohort
time perspective: Prospective
measure: Rate of successful tests
time frame: 1 hour
description: Number of tests yieling a result (whatever the value)
measure: Sensitivity
time frame: Through study completion, an average of 1 month
description: Rate of true positive test results (comparison with oestradiol level in blood sample, as gold standard)
measure: Specificity
time frame: Through study completion, an average of 1 month
description: Rate of true negative test results (comparison with oestradiol level in blood sample, as gold standard)
arm group label: Women with ovarian stimulation
description: Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring Dosage of oestradiol
intervention type: Diagnostic Test
intervention name: Dosage of oestradiol
description: The study is based on a concept using capillary blood tests using lateral flow by migration on membrane similarly to a pregnancy test, patented by a french company (NGBiotech).
This study is therefore a feasibility study of a rapid test for oestradiol dosage during monitoring of ovarian stimulation.
arm group label: Women with ovarian stimulation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Celia RAVEL, MD, PhD
role: Study Director
affiliation: CHU Rennes
last name: Celia RAVEL, MD, PhD
phone: +3332 99 26 59 16
email: cela.ravel@chu-rennes.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Infertility
mesh term: Estradiol
sharing ipd: No