<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/NCT03272412</url>
  </required_header>
  <id_info>
    <org_study_id>1704-VLC-024-EL</org_study_id>
    <nct_id>NCT03272412</nct_id>
  </id_info>
  <brief_title>Serum Progesterone on the Day of Embryo Transfer and Pregnancy Rate.</brief_title>
  <official_title>Impact of Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Endometrial Preparation Cycles on the Ongoing Pregnancy Rate.</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to analyze whether serum Progsterone levels on the day of Embryo Transfer are&#xD;
      related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with&#xD;
      intravaginal micronized progesterone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Actual">November 28, 2018</completion_date>
  <primary_completion_date type="Actual">November 28, 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>Concentration of serum Progesterone levels</measure>
    <time_frame>The day of embryo transfer</time_frame>
    <description>Serum progesterone levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ongoing Pregnancies depending on Progesterone levels ranges.</measure>
    <time_frame>Week 5-12 after Embryo Transfer</time_frame>
    <description>Ultrasound to confirm Ongoing Pregnancy</description>
  </primary_outcome>
  <enrollment type="Actual">1205</enrollment>
  <condition>Ongoing Pregnancy Rate</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Analysis of serum Progesterone in blood sample</intervention_name>
    <description>Levels of progesterone will be determined on the day of embryo transfer in patients undergoing artificial endometrial preparation cycles.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women who are undergoing IVF treatments with artificial endometrial preparation with&#xD;
        hormonal replacement therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Age &lt;50 years old&#xD;
&#xD;
          2. Hormonal Replacement therapy cycle for embryo transfer in any of the following&#xD;
             situations:&#xD;
&#xD;
               1. Embryos in fresh cycle with donated oocytes.&#xD;
&#xD;
               2. Subsequent embryo transfers of vitrified embryos in cycles of donated oocytes.&#xD;
&#xD;
               3. Frozen embryo transfers in cycles with autologous oocytes.&#xD;
&#xD;
          3. Endometrial line: &gt;6.5-7mm (with trilaminar aspect) in proliferative phase, before&#xD;
             introducing progesterone.&#xD;
&#xD;
          4. Administration of natural micronized progesterone intravaginally (400 mg/12 hours for&#xD;
             5 complete days (10 dosis), before the embryo transfer and maintained until pregnancy&#xD;
             week 12.&#xD;
&#xD;
          5. Embryo transfer of blastocyst (day 5-6).&#xD;
&#xD;
          6. Signed Informed Consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Uterine pathology (submucous o intramural fibroids (&gt;4 cm) or which deform the uterine&#xD;
             cavity; endometrial polyps or Müllerian anomalies; or adnexal anomalies (communicating&#xD;
             hydrosalpinx).&#xD;
&#xD;
          2. Simultaneous participation in another clinical study.&#xD;
&#xD;
          3. Participation in another clinical study before the inclusion in the present study, and&#xD;
             which could affect the objectives of the present study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Instituto Valenciano de Infertilidad Spain</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 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>Elena Labarta</investigator_full_name>
    <investigator_title>Gynecologist IVI Valencia</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</mesh_term>
  </intervention_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/NCT03272412
org study id: 1704-VLC-024-EL
nct id: NCT03272412
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to analyze whether serum Progsterone levels on the day of Embryo Transfer are
      related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with
      intravaginal micronized progesterone.
observational model: Cohort
time perspective: Prospective
measure: Concentration of serum Progesterone levels
time frame: The day of embryo transfer
description: Serum progesterone levels
measure: Ongoing Pregnancies depending on Progesterone levels ranges.
time frame: Week 5-12 after Embryo Transfer
description: Ultrasound to confirm Ongoing Pregnancy
intervention type: Diagnostic Test
intervention name: Analysis of serum Progesterone in blood sample
description: Levels of progesterone will be determined on the day of embryo transfer in patients undergoing artificial endometrial preparation cycles.
Serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Instituto Valenciano de Infertilidad, IVI VALENCIA
investigator full name: Elena Labarta
investigator title: Gynecologist IVI Valencia
mesh term: Progesterone