<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/NCT04496284</url>
  </required_header>
  <id_info>
    <org_study_id>RMA-2020-03</org_study_id>
    <nct_id>NCT04496284</nct_id>
  </id_info>
  <brief_title>Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen</brief_title>
  <official_title>Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Reproductive Medicine Associates of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Reproductive Medicine Associates of New Jersey</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>
      The proposed study is a single-blind randomized controlled trial which seeks to characterize&#xD;
      implantation rates following embryo vitrification and subsequent warming with both slush&#xD;
      nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will&#xD;
      be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine if slush nitrogen for embryo vitrification results&#xD;
      in higher sustained implantation rates compared to the conventional use of liquid nitrogen.&#xD;
      Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst&#xD;
      stage embryos will be randomized to either the control (liquid nitrogen) or intervention&#xD;
      group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A&#xD;
      (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will&#xD;
      be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates&#xD;
      and pregnancy outcomes will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2020</start_date>
  <completion_date type="Actual">December 20, 2022</completion_date>
  <primary_completion_date type="Actual">May 3, 2022</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sustained implantation rate</measure>
    <time_frame>approximately 8 weeks gestation age</time_frame>
    <description>fetal heart beat present upon discharge at 8 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>usually by 5 weeks gestational age</time_frame>
    <description>presence of gestational sac in uterus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>miscarriage rate</measure>
    <time_frame>1-8 months dependent on gestational age of loss</time_frame>
    <description>pregnancy loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>live birth rate</measure>
    <time_frame>9 months</time_frame>
    <description>delivery of live infant</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">253</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Vitrification via slush nitrogen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blastocyst stage embryos will be vitrified via slush nitrogen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitrification via liquid nitrogen</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vitrification via slush nitrogen</intervention_name>
    <description>blastocyst stage embryos will be vitrified via slush nitrogen</description>
    <arm_group_label>Vitrification via slush nitrogen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Major Inclusion Criteria for participants:&#xD;
&#xD;
          1. Patients undergoing IVF stimulation cycle with plan for subsequent frozen embryo&#xD;
             transfer (FET)&#xD;
&#xD;
          2. Patients electing preimplantation genetic testing for aneuploidy (PGT-A)&#xD;
&#xD;
          3. Couples electing single embryo transfer (SET)&#xD;
&#xD;
        Major Exclusion Criteria for participants:&#xD;
&#xD;
          1. All patients who do not voluntarily give their written consent for participation&#xD;
&#xD;
          2. Under 18 years old, above 42 years old&#xD;
&#xD;
          3. BMI &gt; 35&#xD;
&#xD;
          4. Maximum day 3 Follicle stimulating hormone (FSH) level of 12 or higher&#xD;
&#xD;
          5. Anti-mullerian hormone (AMH) level less than 1.0 g/mL, tested within previous year&#xD;
&#xD;
          6. Total basal antral follicle count less than 6 follicles&#xD;
&#xD;
          7. Failed more than one previous FET cycle&#xD;
&#xD;
          8. Use of oocyte donation&#xD;
&#xD;
          9. Use of gestational carrier&#xD;
&#xD;
         10. Presence of hydrosalpinges that communicate with endometrial cavity&#xD;
&#xD;
         11. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness&#xD;
             ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance),&#xD;
             persistent endometrial fluid&#xD;
&#xD;
         12. Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine&#xD;
             septum)&#xD;
&#xD;
         13. Single gene disorder chromosomal rearrangement requiring a more detailed embryonic&#xD;
             genetic analysis&#xD;
&#xD;
         14. Male partner with &lt;100,000 total motile spermatozoa per ejaculate (donor sperm is&#xD;
             acceptable)&#xD;
&#xD;
         15. Use of surgical procedures to obtain sperm&#xD;
&#xD;
         16. Couples undergoing IVF for fertility preservation with no immediate plan for&#xD;
             subsequent FET (embryo banking)&#xD;
&#xD;
         17. Sex selection&#xD;
&#xD;
         18. Personal history of repeated pregnancy loss (two or more unexplained clinical losses&#xD;
             defined by presence of fetal heartbeat)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Reproductive Medicine Assoicates of New Jersey</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_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/NCT04496284
org study id: RMA-2020-03
nct id: NCT04496284
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed study is a single-blind randomized controlled trial which seeks to characterize
      implantation rates following embryo vitrification and subsequent warming with both slush
      nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will
      be assessed.
The purpose of this study is to determine if slush nitrogen for embryo vitrification results
      in higher sustained implantation rates compared to the conventional use of liquid nitrogen.
      Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst
      stage embryos will be randomized to either the control (liquid nitrogen) or intervention
      group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A
      (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will
      be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates
      and pregnancy outcomes will be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: sustained implantation rate
time frame: approximately 8 weeks gestation age
description: fetal heart beat present upon discharge at 8 weeks
measure: clinical pregnancy rate
time frame: usually by 5 weeks gestational age
description: presence of gestational sac in uterus
measure: miscarriage rate
time frame: 1-8 months dependent on gestational age of loss
description: pregnancy loss
measure: live birth rate
time frame: 9 months
description: delivery of live infant
arm group label: Vitrification via slush nitrogen
arm group type: Experimental
description: Blastocyst stage embryos will be vitrified via slush nitrogen
arm group label: Vitrification via liquid nitrogen
arm group type: No Intervention
description: Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care.
intervention type: Other
intervention name: Vitrification via slush nitrogen
description: blastocyst stage embryos will be vitrified via slush nitrogen
arm group label: Vitrification via slush nitrogen
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infertility
sharing ipd: No