<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/NCT03817060</url>
  </required_header>
  <id_info>
    <org_study_id>SRB_201807_150</org_study_id>
    <nct_id>NCT03817060</nct_id>
  </id_info>
  <brief_title>CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage</brief_title>
  <acronym>MELISSA</acronym>
  <official_title>CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage in a Single Embryo Transfer Setting (MELISSA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université Libre de Bruxelles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université Libre de Bruxelles</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>
      Ovarian stimulation for the induction of multifollicular growth by gonadotrophins represents&#xD;
      an important part of In Vitro Fertilization (IVF). However, the use of these drugs can be&#xD;
      associated with side effects, from which the most common is the Ovarian Hyperstimulation&#xD;
      Syndrome (OHSS). Stimulation with gonadotrophins in a Gonadotropin-releasing hormone (GnRH)&#xD;
      antagonist cycle rather than a GnRH agonist cycle reduces significantly the risk of OHSS.&#xD;
      During stimulation, the best predictor of severe OHSS is the number of follicles &gt;10mm on the&#xD;
      day of triggering final oocyte maturation, with the threshold at ≥16 follicles. When this&#xD;
      occurs, final oocyte maturation can be induced with a GnRH agonist, reducing further the risk&#xD;
      the syndrome. To perform a fresh embryo transfer, 1500 IU human Chorionic Gonadotropin (hCG)&#xD;
      can be administered on the day of oocyte retrieval for the luteal support. However, with this&#xD;
      procedure there are still some cases of OHSS. To overcome this, it is suggested to combine&#xD;
      GnRH agonist triggering with a freeze-all embryos strategy and perform embryo replacement in&#xD;
      subsequent frozen-thawed embryo transfer (FET) cycles. Different cryopreservation strategies&#xD;
      are been performed according to the procedure of each fertility center, such as&#xD;
      cryopreservation at 2 pronuclear (2PN), cleavage or blastocyst stage. The aim of this study&#xD;
      is to determine the optimal strategy for the freeze-all cycles and particularly the optimal&#xD;
      day for freezing, thawing and transferring the embryos. The hypothesis is that there will&#xD;
      increased cumulative live birth rates per started cycle in blastocyst compared to cleavage&#xD;
      stage FET cycles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <phase>N/A</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>Cumulative live birth</measure>
    <time_frame>within one year of randomisation</time_frame>
    <description>Cumulative live birth rate per oocyte retrieval</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frozen thawed embryo transfer cycles needed to achieve live birth</measure>
    <time_frame>within one year of randomisation</time_frame>
    <description>Number of frozen thawed embryo transfer cycles needed to achieve live birth</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Cleavage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Embryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blastocyst</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Embryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cryopreservation of embryos at cleavage stage</intervention_name>
    <description>cryopreservation of embryos at cleavage stage (day 3) of embryo development</description>
    <arm_group_label>Cleavage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cryopreservation of embryos at blastocyst stage</intervention_name>
    <description>cryopreservation of embryos at blastocyst stage (day 5 or 6) of embryo development</description>
    <arm_group_label>Blastocyst</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;40 years old&#xD;
&#xD;
          -  Indication for In Vitro Fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI)&#xD;
&#xD;
          -  No more than 2 previous failed IVF/ICSI cycles&#xD;
&#xD;
          -  Stimulation in GnRH antagonist cycle&#xD;
&#xD;
          -  Presence of ≥16 follicles of &gt;10mm on the day of triggering of final oocyte maturation&#xD;
&#xD;
          -  GnRH agonist trigger (triptorelin 0.2mg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cycles with testicular sperm extraction&#xD;
&#xD;
          -  Preimplantation genetic diagnosis&#xD;
&#xD;
          -  Patients with uterine malformations&#xD;
&#xD;
          -  Patients with infectious diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Theoni Tarlatzi</last_name>
    <phone>+3225558948</phone>
    <email>nonika.tarlatzi@gmail.com</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université Libre de Bruxelles</investigator_affiliation>
    <investigator_full_name>Theoni Tarlatzi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>OHSS</keyword>
  <keyword>Agonist trigger</keyword>
  <keyword>freeze-all</keyword>
  <keyword>blastocyst</keyword>
  <keyword>cleavage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT03817060
org study id: SRB_201807_150
nct id: NCT03817060
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ovarian stimulation for the induction of multifollicular growth by gonadotrophins represents
      an important part of In Vitro Fertilization (IVF). However, the use of these drugs can be
      associated with side effects, from which the most common is the Ovarian Hyperstimulation
      Syndrome (OHSS). Stimulation with gonadotrophins in a Gonadotropin-releasing hormone (GnRH)
      antagonist cycle rather than a GnRH agonist cycle reduces significantly the risk of OHSS.
      During stimulation, the best predictor of severe OHSS is the number of follicles >10mm on the
      day of triggering final oocyte maturation, with the threshold at ≥16 follicles. When this
      occurs, final oocyte maturation can be induced with a GnRH agonist, reducing further the risk
      the syndrome. To perform a fresh embryo transfer, 1500 IU human Chorionic Gonadotropin (hCG)
      can be administered on the day of oocyte retrieval for the luteal support. However, with this
      procedure there are still some cases of OHSS. To overcome this, it is suggested to combine
      GnRH agonist triggering with a freeze-all embryos strategy and perform embryo replacement in
      subsequent frozen-thawed embryo transfer (FET) cycles. Different cryopreservation strategies
      are been performed according to the procedure of each fertility center, such as
      cryopreservation at 2 pronuclear (2PN), cleavage or blastocyst stage. The aim of this study
      is to determine the optimal strategy for the freeze-all cycles and particularly the optimal
      day for freezing, thawing and transferring the embryos. The hypothesis is that there will
      increased cumulative live birth rates per started cycle in blastocyst compared to cleavage
      stage FET cycles.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cumulative live birth
time frame: within one year of randomisation
description: Cumulative live birth rate per oocyte retrieval
measure: Frozen thawed embryo transfer cycles needed to achieve live birth
time frame: within one year of randomisation
description: Number of frozen thawed embryo transfer cycles needed to achieve live birth
arm group label: Cleavage
arm group type: Active Comparator
description: Embryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development
arm group label: Blastocyst
arm group type: Active Comparator
description: Embryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6)
intervention type: Procedure
intervention name: cryopreservation of embryos at cleavage stage
description: cryopreservation of embryos at cleavage stage (day 3) of embryo development
arm group label: Cleavage
intervention type: Procedure
intervention name: cryopreservation of embryos at blastocyst stage
description: cryopreservation of embryos at blastocyst stage (day 5 or 6) of embryo development
arm group label: Blastocyst
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Theoni Tarlatzi
phone: +3225558948
email: nonika.tarlatzi@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Université Libre de Bruxelles
investigator full name: Theoni Tarlatzi
investigator title: Principal Investigator
mesh term: Infertility
sharing ipd: Undecided