<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/NCT04487925</url>
  </required_header>
  <id_info>
    <org_study_id>B6702020000326</org_study_id>
    <nct_id>NCT04487925</nct_id>
  </id_info>
  <brief_title>Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders</brief_title>
  <acronym>MONACO</acronym>
  <official_title>A Randomized Comparison of One Controlled Ovarian Stimulation With Corifollitropin Alfa Versus up to Three Modified Natural Cycles in Expected and Established Poor Responders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized, single center, phase 4 controlled trial. The study will&#xD;
      compare the efficacy of two different strategies for the management of predicted poor&#xD;
      response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a&#xD;
      single GnRH antagonist CFA (group 2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 25, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>Phase 4</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>Number of good quality blastocysts after CFA stimulation vs. after a first MNC</measure>
    <time_frame>On fifth day of embryonal development</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC</measure>
    <time_frame>On fifth day of embryonal development</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relative number of blastocysts after ART, relative to the number of oocytes</measure>
    <time_frame>On fifth day of embryonal development</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The probability of having at least one blastocyst of good quality after ART</measure>
    <time_frame>On fifth day of embryonal development</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>The probability of having an ongoing pregnancy</measure>
    <time_frame>6 to 8 weeks gestational age</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The time until ongoing pregnancy</measure>
    <time_frame>6 to 8 weeks gestational age</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">208</enrollment>
  <condition>Ovarian Reserve</condition>
  <condition>Poor Responders</condition>
  <condition>IVF</condition>
  <arm_group>
    <arm_group_label>Up to 3 modified natural cycles</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Controlled ovarian stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation</intervention_name>
    <description>CFA will be administered in combination with Follitropin beta.</description>
    <arm_group_label>Controlled ovarian stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Up to three modified natural cycles with Follitropin beta.</intervention_name>
    <description>Follitropin beta in a low dose will be given.</description>
    <arm_group_label>Up to 3 modified natural cycles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent form (ICF) dated and signed.&#xD;
&#xD;
          -  Age ≥18 and &lt;45 years old.&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥18.5 Kg/m² and &lt;35 Kg/m².&#xD;
&#xD;
          -  Regular menstrual cycles (between 21 and 35 days).&#xD;
&#xD;
          -  Two ovaries present.&#xD;
&#xD;
          -  Current pregnancy wish.&#xD;
&#xD;
          -  Poor responders as defined according to the POSEIDON criteria:&#xD;
&#xD;
        POSEIDON Group 3: patients &lt; 35 years with poor ovarian reserve pre-stimulation parameters&#xD;
        (AFC &lt;5 or AMH &lt;1.2 ng/mL); POSEIDON Group 4: patients ≥35 years with poor ovarian reserve&#xD;
        pre-stimulation parameters (AFC &lt;5 or AMH &lt;1.2 ng/mL).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Simultaneous participation in another clinical study.&#xD;
&#xD;
          -  Untreated and uncontrolled thyroid dysfunction.&#xD;
&#xD;
          -  Tumors of the ovary, breast, uterus, pituitary or hypothalamus.&#xD;
&#xD;
          -  Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.&#xD;
&#xD;
          -  Ovarian cysts or enlarged ovaries.&#xD;
&#xD;
          -  Malformations of the reproductive organs.&#xD;
&#xD;
          -  Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy.&#xD;
&#xD;
          -  Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).&#xD;
&#xD;
          -  Patients who undergo preimplantation genetic testing (PGT), fertility preservation or&#xD;
             oocyte donation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominic Stoop, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sara Somers, MSc</last_name>
    <phone>0032 9 332 30 48</phone>
    <email>studieco.vrouwenkliniek@uzgent.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Ghent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominic Stoop</last_name>
      <email>dominic.stoop@uzgent.be</email>
    </contact>
    <contact_backup>
      <last_name>Rebecca De Beir</last_name>
      <email>rebecca.debeir@uzgent.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
    <mesh_term>Follicle Stimulating Hormone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04487925
org study id: B6702020000326
nct id: NCT04487925
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomized, single center, phase 4 controlled trial. The study will
      compare the efficacy of two different strategies for the management of predicted poor
      response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a
      single GnRH antagonist CFA (group 2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of good quality blastocysts after CFA stimulation vs. after a first MNC
time frame: On fifth day of embryonal development
measure: Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC
time frame: On fifth day of embryonal development
measure: The relative number of blastocysts after ART, relative to the number of oocytes
time frame: On fifth day of embryonal development
measure: The probability of having at least one blastocyst of good quality after ART
time frame: On fifth day of embryonal development
measure: The probability of having an ongoing pregnancy
time frame: 6 to 8 weeks gestational age
measure: The time until ongoing pregnancy
time frame: 6 to 8 weeks gestational age
arm group label: Up to 3 modified natural cycles
arm group type: Active Comparator
arm group label: Controlled ovarian stimulation
arm group type: Experimental
intervention type: Drug
intervention name: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation
description: CFA will be administered in combination with Follitropin beta.
arm group label: Controlled ovarian stimulation
intervention type: Drug
intervention name: Up to three modified natural cycles with Follitropin beta.
description: Follitropin beta in a low dose will be given.
arm group label: Up to 3 modified natural cycles
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: No
last name: Dominic Stoop, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Ghent
last name: Sara Somers, MSc
phone: 0032 9 332 30 48
email: studieco.vrouwenkliniek@uzgent.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Sponsor
mesh term: Hormones
mesh term: Follicle Stimulating Hormone
sharing ipd: No