<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/NCT04482751</url>
  </required_header>
  <id_info>
    <org_study_id>184/2020</org_study_id>
    <nct_id>NCT04482751</nct_id>
  </id_info>
  <brief_title>The Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa</brief_title>
  <acronym>ACO</acronym>
  <official_title>An Observational Single Center Study to Identify the Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa (ACO Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero-Universitaria di Modena</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliero-Universitaria di Modena</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the trend of serum AMH during IVF (in vitro&#xD;
      fertilization) cycles, in particular the possible relationship between the dynamics of AMH&#xD;
      and the early or normal response to therapies for controlled ovarian stimulation with&#xD;
      corifollitropin alfa. The secondary objective is to study the association between the number&#xD;
      of follicles equal to or greater than 17 mm on the eighth day of ovarian stimulation and the&#xD;
      decline in AMH, and to assess the predictability of the need to add additional therapies&#xD;
      after the first week of stimulation ovarian.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is observational and it is monocentric, and it will involve 80 patients. Patients'&#xD;
      data, extrapolated from the medical records of the Department of Reproductive Medicine in the&#xD;
      Policlinico Hospital in Modena, will be collected in an internal database for analysis. The&#xD;
      inclusion criteria for the population included in the study will be: 1) basal serum FSH&#xD;
      concentration below 20 UI/L; 2) age between 18 and 46 years; 3) body weight &gt; 60 kg; 4) use&#xD;
      of corifollitrofin alpha for ovarian stimulation. The following parameters will be evaluated:&#xD;
      the age of the patients, their weight, their body mass index (BMI), duration of infertility,&#xD;
      cycle characteristics; basal (day 2) AMH, AFC measurement, basal estradiol, basal&#xD;
      progesterone, basal FSH, basal LH, and those same values on day 5 and day 8 of ovarian&#xD;
      stimulation; follicles ≥ 17 mm on day 8, type of gonadothropin further added, days of&#xD;
      stimulation with the further gonadothropin and its units per day, AMH on trigger day and the&#xD;
      number of oocytes retrieved. The confidentiality of the informations will be guaranteed by&#xD;
      anonymized data analysis. All the data are commonly recorded in our clinical practice.&#xD;
&#xD;
      The observed period will be of 12 months. The date of conclusion of the study, after&#xD;
      favorable opinion of the Ethics Committee and the authorization of the Company Management, is&#xD;
      scheduled for June 2021.&#xD;
&#xD;
      To guarantee the consent and the information of the patients involved in the study, the&#xD;
      Information Sheet and the relative Consent Form are attached. We consider appropriate to&#xD;
      inform the General Physician of the enlisted patients about the study: the Information Letter&#xD;
      for the General Physician is therefore attached.&#xD;
&#xD;
      Variables/Time Points of Interest&#xD;
&#xD;
      The variables which will be recorded on cycle day 2 of a spontaneous menstruation&#xD;
      (stimulation day 1 with Corifollitropin alfa) are: woman's age (years), weight (kg),&#xD;
      body-mass-index (kg/m2), duration of infertility (months), cycle length (in days, by patient&#xD;
      recall), cycle regularity (yes/no; deviation of &gt; 5 days from two consecutive cycles is&#xD;
      considered an irregular cycle), total number of antral follicles (2-10 mm) in both ovaries&#xD;
      (AFC) measured by a transvaginal scan and serum AMH (ng/ml), oestradiol, progesterone, FSH&#xD;
      and LH.&#xD;
&#xD;
      Patients will return every two days to the clinic for a transvaginal ultrasound from&#xD;
      stimulation day 5 up to and including the day of hCG. Serum hormone concentrations (FSH, LH,&#xD;
      oestradiol, progesterone and AMH) will be measured on stimulation days 5 and 8 and on the day&#xD;
      of hCG.&#xD;
&#xD;
      All hormones reported above will be measured in the central lab of the ospital as per routine&#xD;
      practice. Remaining serum will be used for the AMH assay. The measurement of the AMH will ber&#xD;
      profrmed in the ObGyn University research Lab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Changes in serum Antimullerian Hormone (AMH) levels during ovarian stimulation</measure>
    <time_frame>AMH will be measured at day 2, day 5, day 8 and the last day (usually day 11) of ovarian stimulation</time_frame>
    <description>Serum concentrations of AMH will be measured during ovarian stimulation with corifollitropin alfa.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>Infertile women</arm_group_label>
    <description>the group consists of 80 infertile patients undergoing IVF</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corifollitropin alfa</intervention_name>
    <description>AMH will be measured during ovarian stimulation with corifollitropin alfa</description>
    <arm_group_label>Infertile women</arm_group_label>
    <other_name>no other interventions</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Infertile patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  basal serum FSH concentration below 20 UI/L&#xD;
&#xD;
          -  age between 18 and 46 years&#xD;
&#xD;
          -  body weight &gt; 60 kg&#xD;
&#xD;
          -  use of corifollitrofin alpha for ovarian stimulation.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  contraindications to IVF&#xD;
&#xD;
          -  irregular menstrual cycles&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio La Marca</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Modena and Reggio Emilia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antonio La Marca</last_name>
    <phone>+390594224671</phone>
    <email>antlamarca@libero.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Antonio La Marca</last_name>
    <phone>3384795303</phone>
    <email>antlamarca@libero.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <state>Modena - MO</state>
        <zip>41123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio La Marca</last_name>
      <phone>3384795303</phone>
      <email>antlamarca@libero.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>February 5, 2023</last_update_submitted>
  <last_update_submitted_qc>February 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero-Universitaria di Modena</investigator_affiliation>
    <investigator_full_name>Antonio La Marca</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>
  <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/NCT04482751
org study id: 184/2020
nct id: NCT04482751
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The objective of this study is to evaluate the trend of serum AMH during IVF (in vitro
      fertilization) cycles, in particular the possible relationship between the dynamics of AMH
      and the early or normal response to therapies for controlled ovarian stimulation with
      corifollitropin alfa. The secondary objective is to study the association between the number
      of follicles equal to or greater than 17 mm on the eighth day of ovarian stimulation and the
      decline in AMH, and to assess the predictability of the need to add additional therapies
      after the first week of stimulation ovarian.
The study is observational and it is monocentric, and it will involve 80 patients. Patients'
      data, extrapolated from the medical records of the Department of Reproductive Medicine in the
      Policlinico Hospital in Modena, will be collected in an internal database for analysis. The
      inclusion criteria for the population included in the study will be: 1) basal serum FSH
      concentration below 20 UI/L; 2) age between 18 and 46 years; 3) body weight > 60 kg; 4) use
      of corifollitrofin alpha for ovarian stimulation. The following parameters will be evaluated:
      the age of the patients, their weight, their body mass index (BMI), duration of infertility,
      cycle characteristics; basal (day 2) AMH, AFC measurement, basal estradiol, basal
      progesterone, basal FSH, basal LH, and those same values on day 5 and day 8 of ovarian
      stimulation; follicles ≥ 17 mm on day 8, type of gonadothropin further added, days of
      stimulation with the further gonadothropin and its units per day, AMH on trigger day and the
      number of oocytes retrieved. The confidentiality of the informations will be guaranteed by
      anonymized data analysis. All the data are commonly recorded in our clinical practice.

      The observed period will be of 12 months. The date of conclusion of the study, after
      favorable opinion of the Ethics Committee and the authorization of the Company Management, is
      scheduled for June 2021.

      To guarantee the consent and the information of the patients involved in the study, the
      Information Sheet and the relative Consent Form are attached. We consider appropriate to
      inform the General Physician of the enlisted patients about the study: the Information Letter
      for the General Physician is therefore attached.

      Variables/Time Points of Interest

      The variables which will be recorded on cycle day 2 of a spontaneous menstruation
      (stimulation day 1 with Corifollitropin alfa) are: woman's age (years), weight (kg),
      body-mass-index (kg/m2), duration of infertility (months), cycle length (in days, by patient
      recall), cycle regularity (yes/no; deviation of > 5 days from two consecutive cycles is
      considered an irregular cycle), total number of antral follicles (2-10 mm) in both ovaries
      (AFC) measured by a transvaginal scan and serum AMH (ng/ml), oestradiol, progesterone, FSH
      and LH.

      Patients will return every two days to the clinic for a transvaginal ultrasound from
      stimulation day 5 up to and including the day of hCG. Serum hormone concentrations (FSH, LH,
      oestradiol, progesterone and AMH) will be measured on stimulation days 5 and 8 and on the day
      of hCG.

      All hormones reported above will be measured in the central lab of the ospital as per routine
      practice. Remaining serum will be used for the AMH assay. The measurement of the AMH will ber
      profrmed in the ObGyn University research Lab.
observational model: Cohort
time perspective: Prospective
measure: Changes in serum Antimullerian Hormone (AMH) levels during ovarian stimulation
time frame: AMH will be measured at day 2, day 5, day 8 and the last day (usually day 11) of ovarian stimulation
description: Serum concentrations of AMH will be measured during ovarian stimulation with corifollitropin alfa.
arm group label: Infertile women
description: the group consists of 80 infertile patients undergoing IVF
intervention type: Drug
intervention name: Corifollitropin alfa
description: AMH will be measured during ovarian stimulation with corifollitropin alfa
arm group label: Infertile women
other name: no other interventions
blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: No
last name: Antonio La Marca
role: Principal Investigator
affiliation: University of Modena and Reggio Emilia
last name: Antonio La Marca
phone: +390594224671
email: antlamarca@libero.it
last name: Antonio La Marca
phone: 3384795303
email: antlamarca@libero.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero-Universitaria di Modena
investigator full name: Antonio La Marca
investigator title: Professor
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: Undecided