<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/NCT02237781</url>
  </required_header>
  <id_info>
    <org_study_id>NV24042014</org_study_id>
    <nct_id>NCT02237781</nct_id>
  </id_info>
  <brief_title>Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins</brief_title>
  <official_title>Prospective Randomized Trial on the Level of Anti-Mullerian Hormone (AMH) in Women Undergoing Controlled Ovarian Stimulation for IVFwith Gonadotropins.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lito Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Athens</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anti-Mullerian Hormone (AMH) is produced only in small ovarian follicles with quite stable&#xD;
      levels during the cycle. There is not yet sufficient data to inform couples undergoing IVF&#xD;
      about the effect of ovarian stimulation on the levels of AMH due to the increasing size of&#xD;
      follicles and chances of success of the method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing IVF will be included in the study. All patients will be counseled&#xD;
      regarding their prognosis. Anti-Mullerian Hormone (AMH) will be measured prior to the&#xD;
      initiation of IVF and during ovarian stimulation. Patients will be stimulated with a short&#xD;
      GnRH-antagonist protocol. All women will have measurements of serum FSH and estradiol (E2)&#xD;
      and a pelvic sonogram on the second day of their cycle. Ovarian stimulation will be initiated&#xD;
      with of gonadotropins either in the form of a combination of highly purified urinary FSH and&#xD;
      LH or with a combination of Rec FSH and Rec LH. The dose of gonadotropins will depend on the&#xD;
      levels of estradiol and FSH prior stimulation. All patients will be re-evaluated on day 3 and&#xD;
      5 of the stimulation (measurment of AMH, E2 and pelvic sonogram), and dosage adjustments will&#xD;
      be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated on day 5.&#xD;
      Measurment of AMH, E2 and pelvic sonogram to conferm the size of follicles will be continue&#xD;
      every second day untill the oocyte retrieval. When at least 2 follicles reach an average&#xD;
      diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl,&#xD;
      Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. Patients with&#xD;
      successful fertilization will have embryo transfer under sonographic guidance on day 3 after&#xD;
      retrieval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of AMH</measure>
    <time_frame>6 months</time_frame>
    <description>Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment and during ovarian stimulation.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Female Infertility</condition>
  <arm_group>
    <arm_group_label>AMH levels</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists. Levels of AMH will be measured prior and during the ovarian stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gonadotropins</intervention_name>
    <description>The dose of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH will depend on the levels of E2 and FSH prior to ovarian stimulation .</description>
    <arm_group_label>AMH levels</arm_group_label>
    <other_name>Menopure</other_name>
    <other_name>Gonal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All infertile women undergoing ovarian stimulation for IVF.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who can not undergo IVF&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikos Vlahos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Athens, 2nd Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nikos Vlahos, MD</last_name>
    <phone>30 210 7286000</phone>
    <phone_ext>256</phone_ext>
    <email>nikosvlahos@med.uoa.gr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Olga Triantafyllidou, MD</last_name>
    <phone>30 2107485591</phone>
    <email>triantafyllidouolga@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Athens</investigator_affiliation>
    <investigator_full_name>Nikos Vlahos</investigator_full_name>
    <investigator_title>Associate Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>AMH</keyword>
  <keyword>IVF</keyword>
  <keyword>ovarian stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_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/NCT02237781
org study id: NV24042014
nct id: NCT02237781
lead sponsor: 
collaborator: 
has dmc: Yes
Anti-Mullerian Hormone (AMH) is produced only in small ovarian follicles with quite stable
      levels during the cycle. There is not yet sufficient data to inform couples undergoing IVF
      about the effect of ovarian stimulation on the levels of AMH due to the increasing size of
      follicles and chances of success of the method.
Patients undergoing IVF will be included in the study. All patients will be counseled
      regarding their prognosis. Anti-Mullerian Hormone (AMH) will be measured prior to the
      initiation of IVF and during ovarian stimulation. Patients will be stimulated with a short
      GnRH-antagonist protocol. All women will have measurements of serum FSH and estradiol (E2)
      and a pelvic sonogram on the second day of their cycle. Ovarian stimulation will be initiated
      with of gonadotropins either in the form of a combination of highly purified urinary FSH and
      LH or with a combination of Rec FSH and Rec LH. The dose of gonadotropins will depend on the
      levels of estradiol and FSH prior stimulation. All patients will be re-evaluated on day 3 and
      5 of the stimulation (measurment of AMH, E2 and pelvic sonogram), and dosage adjustments will
      be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated on day 5.
      Measurment of AMH, E2 and pelvic sonogram to conferm the size of follicles will be continue
      every second day untill the oocyte retrieval. When at least 2 follicles reach an average
      diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl,
      Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. Patients with
      successful fertilization will have embryo transfer under sonographic guidance on day 3 after
      retrieval.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Level of AMH
time frame: 6 months
description: Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment and during ovarian stimulation.
arm group label: AMH levels
arm group type: Experimental
description: Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists. Levels of AMH will be measured prior and during the ovarian stimulation.
intervention type: Drug
intervention name: Gonadotropins
description: The dose of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH will depend on the levels of E2 and FSH prior to ovarian stimulation .
arm group label: AMH levels
other name: Menopure
other name: Gonal
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nikos Vlahos, MD
role: Principal Investigator
affiliation: University of Athens, 2nd Department of Obstetrics and Gynecology
last name: Nikos Vlahos, MD
phone: 30 210 7286000
phone ext: 256
email: nikosvlahos@med.uoa.gr
last name: Olga Triantafyllidou, MD
phone: 30 2107485591
email: triantafyllidouolga@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: University of Athens
investigator full name: Nikos Vlahos
investigator title: Associate Professor of Obstetrics and Gynecology
mesh term: Infertility
mesh term: Infertility, Female