xml: <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/NCT05987657</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL23_0644</org_study_id>
      <nct_id>NCT05987657</nct_id>
    </id_info>
    <brief_title>Assessment of Two Methods for Progesterone Dosage During IVF</brief_title>
    <acronym>SALIPROG</acronym>
    <official_title>Comparison of Two Methods to Assess Progesterone Concentration in Patient During IVF Protocol on Triggering Day: Salivary Versus Blood Test</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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>
        Nowadays, 1/7 couple consult because of infertility and some of them will need in vitro&#xD;
        fertilization +/- intracytoplasmic sperm injection (IVF+/- ICSI). The IVF process includes a&#xD;
        14 days stimulation with FSH +/- LH in an agonist or antagonist protocol. The monitoring&#xD;
        consists of regular ultrasound scan and blood sample. During the stimulation protocol many&#xD;
        test have been proposed to predict the success of IVF. However, progesterone dosage on&#xD;
        triggering day seems to be the only relevant exam. Indeed, when the progesterone blood&#xD;
        concentration is low, the pregnancy rate is decreased. The only way to obtain progesterone&#xD;
        concentration is a blood sample. The IVF journey is known to be stressful with many&#xD;
        injections. Therefore, the salivary dosage appear to be more patient friendly. This kind of&#xD;
        dosage has already been studied yet never use in routine because of a lack of repeatability.&#xD;
        The laboratory of Lyon has developed a new technique to overcome this issue by using a liquid&#xD;
        chromatography-mass spectrometry.&#xD;
  &#xD;
        The aim of this work is as a first step to assess the repeatability, reliability and&#xD;
        precision of salivary dosage on triggering day for IVF patient compared to blood&#xD;
        concentration of progesterone.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reliability of salivary dosage of progesterone compared to blood sample.</measure>
      <time_frame>At the inclusion</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Infertility</condition>
    <arm_group>
      <arm_group_label>Salivary and blood progesterone dosage</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>IVF patients with fresh embryo transfer having a dosage of progesterone, salivary and blood, on triggering day</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Salivary and blood progesterone dosage</intervention_name>
      <description>Salivary dosage: patient will chew a dry swab for 2 minutes; when the swab is soaked it is put back in its small case and sent to the laboratory for analysis.&#xD;
  In parallel, the same patients will have a blood sample of 4 ml to dose blood progesterone on an EDTA tube. It will be also sent to the laboratory for analysis.&#xD;
  Both analyses will be done only once on triggering day meaning 36 hours before oocyte retrieval.</description>
      <arm_group_label>Salivary and blood progesterone dosage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients between 18 and under 43 years old&#xD;
  &#xD;
            -  in the course of IVF more or less ICSI of the PMA service of the HFME with transfer of&#xD;
               fresh embryo&#xD;
  &#xD;
            -  Signature of an express consent&#xD;
  &#xD;
            -  Understanding the French language, both oral and written.&#xD;
  &#xD;
            -  Affiliated to a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Persons deprived of their liberty by a judicial or administrative decision&#xD;
  &#xD;
            -  Persons subject to psychiatric care&#xD;
  &#xD;
            -  Persons admitted to a health or social establishment for purposes other than research&#xD;
  &#xD;
            -  Participants in another study that could impact the results of the present study, in&#xD;
               particular those related to the level of progesterone.&#xD;
  &#xD;
            -  Adults subject to a legal protection measure (guardianship, curatorship)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>43 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eloise FRAISON, Dr</last_name>
      <phone>04 72 12 94 12</phone>
      <phone_ext>+33</phone_ext>
      <email>eloise.fraison@chu-lyon.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Femme Mère Enfant</name>
        <address>
          <city>Bron</city>
          <state>Rhône</state>
          <zip>69500</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Eloise FRAISON, Dr</last_name>
        <phone>04 72 12 94 12</phone>
        <phone_ext>+33</phone_ext>
        <email>eloise.fraison@chu-lyon.fr</email>
      </contact>
      <investigator>
        <last_name>Eloise FRAISON, Dr</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Progesterone concentration</keyword>
    <keyword>salivary test</keyword>
    <keyword>In vitro fertilization</keyword>
    <keyword>infertility</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>Progesterone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987657
  org study id: 69HCL23_0644
  nct id: NCT05987657
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Nowadays, 1/7 couple consult because of infertility and some of them will need in vitro
        fertilization +/- intracytoplasmic sperm injection (IVF+/- ICSI). The IVF process includes a
        14 days stimulation with FSH +/- LH in an agonist or antagonist protocol. The monitoring
        consists of regular ultrasound scan and blood sample. During the stimulation protocol many
        test have been proposed to predict the success of IVF. However, progesterone dosage on
        triggering day seems to be the only relevant exam. Indeed, when the progesterone blood
        concentration is low, the pregnancy rate is decreased. The only way to obtain progesterone
        concentration is a blood sample. The IVF journey is known to be stressful with many
        injections. Therefore, the salivary dosage appear to be more patient friendly. This kind of
        dosage has already been studied yet never use in routine because of a lack of repeatability.
        The laboratory of Lyon has developed a new technique to overcome this issue by using a liquid
        chromatography-mass spectrometry.
  
        The aim of this work is as a first step to assess the repeatability, reliability and
        precision of salivary dosage on triggering day for IVF patient compared to blood
        concentration of progesterone.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Reliability of salivary dosage of progesterone compared to blood sample.
  time frame: At the inclusion
  arm group label: Salivary and blood progesterone dosage
  arm group type: Other
  description: IVF patients with fresh embryo transfer having a dosage of progesterone, salivary and blood, on triggering day
  intervention type: Diagnostic Test
  intervention name: Salivary and blood progesterone dosage
  description: Salivary dosage: patient will chew a dry swab for 2 minutes; when the swab is soaked it is put back in its small case and sent to the laboratory for analysis.
  In parallel, the same patients will have a blood sample of 4 ml to dose blood progesterone on an EDTA tube. It will be also sent to the laboratory for analysis.
  Both analyses will be done only once on triggering day meaning 36 hours before oocyte retrieval.
  arm group label: Salivary and blood progesterone dosage
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 43 Years
  healthy volunteers: No
  last name: Eloise FRAISON, Dr
  phone: 04 72 12 94 12
  phone ext: +33
  email: eloise.fraison@chu-lyon.fr
  facility: 
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Infertility
  mesh term: Progesterone
  sharing ipd: No