<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/NCT03240159</url>
  </required_header>
  <id_info>
    <org_study_id>Degarelix-AN003</org_study_id>
    <nct_id>NCT03240159</nct_id>
  </id_info>
  <brief_title>Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix</brief_title>
  <official_title>Long Antagonist Protocol for IVF: a Proof of Concept for a Single Luteal GnRH- Antagonist Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assisting Nature</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assisting Nature</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A prospective study of three different doses of Degarelix in late luteal phase of women&#xD;
      undergoing ovarian stimulation for IVF&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective study of three different doses of Degarelix in late luteal phase of women&#xD;
      undergoing ovarian stimulation for IVF:Single dose of Degarelix 24mg, 16mg and 12 mg, on day&#xD;
      24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels,&#xD;
      estradiol levels, and FSH levels.&#xD;
&#xD;
      ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels,&#xD;
      estradiol levels, and FSH levels.&#xD;
&#xD;
      On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels,&#xD;
      estradiol levels, and FSH levels.&#xD;
&#xD;
      On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels,&#xD;
      estradiol levels, and FSH levels.&#xD;
&#xD;
      On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels,&#xD;
      estradiol levels, and FSH levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LH levels</measure>
    <time_frame>4 days after injection of Degarelix</time_frame>
    <description>Effectively down regulation of follicular LH levels (&lt;14mIU/ml)/</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pregnancy, Ovarian</condition>
  <arm_group>
    <arm_group_label>Deg-24mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of Degarelix 24mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deg-16mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of Degarelix 16mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deg-12mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of Degarelix 12mg, on day 24th of previous luteal face cycle.On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.&#xD;
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Degarelix</intervention_name>
    <description>Degarelix 24mg Degarelix 16mg Degarelix 12mg&#xD;
Active Comparator:&#xD;
Down regulation of LH, during exposing in three different doses of Degarelix</description>
    <arm_group_label>Deg-12mg</arm_group_label>
    <arm_group_label>Deg-16mg</arm_group_label>
    <arm_group_label>Deg-24mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary infertility&#xD;
&#xD;
          -  age 18-39 years; body mass index (BMI) 18-29kg/m2;&#xD;
&#xD;
          -  regular menstrual cycle of 26-35days,&#xD;
&#xD;
          -  presumed to be ovulatory;&#xD;
&#xD;
          -  early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women with diabetes and other metabolic disease&#xD;
&#xD;
          -  women with heart disease, QT prolongation,heart failure&#xD;
&#xD;
          -  elevated liver enzymes, liver failure, hepatitis&#xD;
&#xD;
          -  women with inflammatory or autoimmune disease&#xD;
&#xD;
          -  abnormal karyotype;&#xD;
&#xD;
          -  polycystic ovarian syndrome,&#xD;
&#xD;
          -  endometriosis stage III/IV;&#xD;
&#xD;
          -  history of being a 'poor responder',&#xD;
&#xD;
          -  defined as &gt;20 days of gonadotrophin in a previous stimulation cycle, or any previous&#xD;
             cancellation of a stimulation cycle due to limited follicular response, or development&#xD;
             of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent&#xD;
             miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for&#xD;
             the use of gonadotrophins.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evaggelos Papanikolaou, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assisting Nature</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Najdecki, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assisting Nature</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Evaggelos Papanikolaou, MD, PhD</last_name>
    <phone>00302310424294</phone>
    <email>drvagpapanikolaou@yahoo.gr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assisting Nature</name>
      <address>
        <city>Thessaloníki</city>
        <zip>57001</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Najdecki, MD, PhD</last_name>
      <phone>6936646464</phone>
      <email>rnajdecki@assistingnature.gr</email>
    </contact>
    <contact_backup>
      <last_name>Najdecki</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assisting Nature</investigator_affiliation>
    <investigator_full_name>Papanikolaou Evaggelos</investigator_full_name>
    <investigator_title>Papanikolaou Evaggelos, MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy, Ovarian</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/NCT03240159
org study id: Degarelix-AN003
nct id: NCT03240159
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A prospective study of three different doses of Degarelix in late luteal phase of women
      undergoing ovarian stimulation for IVF
A prospective study of three different doses of Degarelix in late luteal phase of women
      undergoing ovarian stimulation for IVF:Single dose of Degarelix 24mg, 16mg and 12 mg, on day
      24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels,
      estradiol levels, and FSH levels.

      ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels,
      estradiol levels, and FSH levels.

      On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels,
      estradiol levels, and FSH levels.

      On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels,
      estradiol levels, and FSH levels.

      On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels,
      estradiol levels, and FSH levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: LH levels
time frame: 4 days after injection of Degarelix
description: Effectively down regulation of follicular LH levels (<14mIU/ml)/
arm group label: Deg-24mg
arm group type: Active Comparator
description: Single dose of Degarelix 24mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
arm group label: Deg-16mg
arm group type: Active Comparator
description: Single dose of Degarelix 16mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
arm group label: Deg-12mg
arm group type: Active Comparator
description: Single dose of Degarelix 12mg, on day 24th of previous luteal face cycle.On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
intervention type: Drug
intervention name: Degarelix
description: Degarelix 24mg Degarelix 16mg Degarelix 12mg
Active Comparator:
Down regulation of LH, during exposing in three different doses of Degarelix
arm group label: Deg-12mg
arm group label: Deg-16mg
arm group label: Deg-24mg
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Evaggelos Papanikolaou, MD, PhD
role: Principal Investigator
affiliation: Assisting Nature
last name: Robert Najdecki, MD, PhD
role: Principal Investigator
affiliation: Assisting Nature
last name: Evaggelos Papanikolaou, MD, PhD
phone: 00302310424294
email: drvagpapanikolaou@yahoo.gr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Assisting Nature
investigator full name: Papanikolaou Evaggelos
investigator title: Papanikolaou Evaggelos, MD, PhD
mesh term: Pregnancy, Ovarian
sharing ipd: Undecided