<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/NCT04472156</url>
  </required_header>
  <id_info>
    <org_study_id>Mosaic</org_study_id>
    <nct_id>NCT04472156</nct_id>
  </id_info>
  <brief_title>A Prospective Study of a Mosaic Embryo Transfer</brief_title>
  <official_title>A Prospective Study of a Mosaic Embryo Transfer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado Center for Reproductive Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Colorado Center for Reproductive Medicine</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>
      This research is a prospective study in which the purpose is to investigate the clinical&#xD;
      outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and&#xD;
      abnormal cells) that has been screened for preimplantation genetic testing (PGT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research is a prospective study with the purpose is to investigate the clinical outcomes&#xD;
      following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal&#xD;
      cells) that has been screened for preimplantation genetic testing (PGT). PGT involves the&#xD;
      biopsy and testing of a handful (3-6) of trophectoderm (pre-placental cells) from the embryo.&#xD;
      Embryos that are screened as mosaic via PGT, as a standard, are not offered for transfer for&#xD;
      pregnancy attempt. Publications have shown that mosaic embryos and mosaic fetuses can result&#xD;
      in healthy live births (Wallerstein et al, 2015; Victor et al, 2019). Ongoing clinical&#xD;
      outcomes are important to further understand the association between an embryonic mosaic&#xD;
      biopsy of pre-placental cells and subsequent fetal chromosomal constitution. Implantation&#xD;
      rates and live birth rates will be evaluated to help understand if mosaic embryos should&#xD;
      routinely be offered for transfer to patients attempting pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2024</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Outcomes will be evaluated with women who have a mosaic embryo transferred</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Implantation rate</measure>
    <time_frame>3-4 weeks after embryo transfer</time_frame>
    <description>Ultrasound will be performed 2-3 weeks after initial positive pregnancy test to confirm viable pregnancy as evidenced by gestational sac in the uterus with a fetal heat rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>9-12 months post embryo transfer</time_frame>
    <description>Live birth rate will be evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Miscarriage Rates</measure>
    <time_frame>5-12 months post embryo transfer</time_frame>
    <description>The rate of miscarriage will be evaluated associated with a mosaic embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Products of conception from miscarriage</measure>
    <time_frame>2-9 months post embryo transfer</time_frame>
    <description>Products of conception will be karyotyped if available following a miscarriage and compared to that of previous PGT testing if the patient is willing to have the testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy complications</measure>
    <time_frame>9-12 months post embryo transfer</time_frame>
    <description>Patient will be evaluated after delivery to assess if patient had any complications associated with the pregnancy. This will be completed with telephone interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stillbirth rates associated with Mosaic Embryo Transfer</measure>
    <time_frame>9-12 months post embryo transfer</time_frame>
    <description>The rate of stillbirths with will be evaluated among patients who have had a mosaic embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prenatal testing</measure>
    <time_frame>9-12 months post embryo transfer</time_frame>
    <description>If available, we will request any results of prenatal testing of karyotype that was obtained via Amniocentesis or Chorionic Villa Sampling (CVS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Outcomes</measure>
    <time_frame>12-15 months after birth of baby</time_frame>
    <description>Patient will be contacted to assess the health of the infant, noting any medical problems if any that the baby has.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Transfer of mosaic embryo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will have a mosaic embryo transferred to their uterus after in vitro fertilization (IVF) with pre implantation genetic testing completed at Colorado Center for Reproductive Medicine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transfer of mosaic embryo</intervention_name>
    <description>Subjects will transfer a mosaic embryo transferred to their uterus</description>
    <arm_group_label>Transfer of mosaic embryo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women age 18-45 Infertile women who have completed an IVF cycle with PGT at the&#xD;
             Colorado Center for Reproductive Medicine (CCRM) that have a mosaic embryo&#xD;
&#xD;
          -  Patients can be of any race, culture, sexual orientation or ethnicity&#xD;
&#xD;
          -  Patients that are willing to transfer a single embryo&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that do not meet the clinical requirements for an embryo transfer per clinic&#xD;
             standards.&#xD;
&#xD;
          -  Patients that desire more than a single embryo transfer.&#xD;
&#xD;
          -  Patients that are using a gestational carrier.&#xD;
&#xD;
          -  Embryonic mosaic PGT results that include chromosome errors 13, 18, 21&#xD;
&#xD;
          -  Patients that did not complete their IVF with PGT cycle at the Colorado Center for&#xD;
             Reproductive Medicine.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mandy Katz-Jaffe, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fertility Genetics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rachel Makloski, RN</last_name>
    <phone>303-788-8300</phone>
    <phone_ext>1769</phone_ext>
    <email>rmakloski@colocrm.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Colorado Center for Reproductive Medicine</name>
      <address>
        <city>Lone Tree</city>
        <state>Colorado</state>
        <zip>80124</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Makloski, RN</last_name>
      <email>TriggerStudy@colocrm.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wallerstein R, Misra S, Dugar RB, Alem M, Mazzoni R, Garabedian MJ. Current knowledge of prenatal diagnosis of mosaic autosomal trisomy in amniocytes: karyotype/phenotype correlations. Prenat Diagn. 2015 Sep;35(9):841-7. doi: 10.1002/pd.4620. Epub 2015 Jun 23.</citation>
    <PMID>25976239</PMID>
  </reference>
  <reference>
    <citation>Victor AR, Tyndall JC, Brake AJ, Lepkowsky LT, Murphy AE, Griffin DK, McCoy RC, Barnes FL, Zouves CG, Viotti M. One hundred mosaic embryos transferred prospectively in a single clinic: exploring when and why they result in healthy pregnancies. Fertil Steril. 2019 Feb;111(2):280-293. doi: 10.1016/j.fertnstert.2018.10.019.</citation>
    <PMID>30691630</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Colorado Center for Reproductive Medicine</investigator_affiliation>
    <investigator_full_name>Mandy Katz-Jaffe</investigator_full_name>
    <investigator_title>Scientific and Genetics Director</investigator_title>
  </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/NCT04472156
org study id: Mosaic
nct id: NCT04472156
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research is a prospective study in which the purpose is to investigate the clinical
      outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and
      abnormal cells) that has been screened for preimplantation genetic testing (PGT).
This research is a prospective study with the purpose is to investigate the clinical outcomes
      following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal
      cells) that has been screened for preimplantation genetic testing (PGT). PGT involves the
      biopsy and testing of a handful (3-6) of trophectoderm (pre-placental cells) from the embryo.
      Embryos that are screened as mosaic via PGT, as a standard, are not offered for transfer for
      pregnancy attempt. Publications have shown that mosaic embryos and mosaic fetuses can result
      in healthy live births (Wallerstein et al, 2015; Victor et al, 2019). Ongoing clinical
      outcomes are important to further understand the association between an embryonic mosaic
      biopsy of pre-placental cells and subsequent fetal chromosomal constitution. Implantation
      rates and live birth rates will be evaluated to help understand if mosaic embryos should
      routinely be offered for transfer to patients attempting pregnancy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Outcomes will be evaluated with women who have a mosaic embryo transferred
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of Implantation rate
time frame: 3-4 weeks after embryo transfer
description: Ultrasound will be performed 2-3 weeks after initial positive pregnancy test to confirm viable pregnancy as evidenced by gestational sac in the uterus with a fetal heat rate
measure: Live birth rate
time frame: 9-12 months post embryo transfer
description: Live birth rate will be evaluated
measure: Miscarriage Rates
time frame: 5-12 months post embryo transfer
description: The rate of miscarriage will be evaluated associated with a mosaic embryo transfer
measure: Products of conception from miscarriage
time frame: 2-9 months post embryo transfer
description: Products of conception will be karyotyped if available following a miscarriage and compared to that of previous PGT testing if the patient is willing to have the testing.
measure: Pregnancy complications
time frame: 9-12 months post embryo transfer
description: Patient will be evaluated after delivery to assess if patient had any complications associated with the pregnancy. This will be completed with telephone interview
measure: Stillbirth rates associated with Mosaic Embryo Transfer
time frame: 9-12 months post embryo transfer
description: The rate of stillbirths with will be evaluated among patients who have had a mosaic embryo transfer
measure: Prenatal testing
time frame: 9-12 months post embryo transfer
description: If available, we will request any results of prenatal testing of karyotype that was obtained via Amniocentesis or Chorionic Villa Sampling (CVS)
measure: Neonatal Outcomes
time frame: 12-15 months after birth of baby
description: Patient will be contacted to assess the health of the infant, noting any medical problems if any that the baby has.
arm group label: Transfer of mosaic embryo
arm group type: Experimental
description: Women will have a mosaic embryo transferred to their uterus after in vitro fertilization (IVF) with pre implantation genetic testing completed at Colorado Center for Reproductive Medicine.
intervention type: Procedure
intervention name: Transfer of mosaic embryo
description: Subjects will transfer a mosaic embryo transferred to their uterus
arm group label: Transfer of mosaic embryo
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mandy Katz-Jaffe, PhD
role: Principal Investigator
affiliation: Fertility Genetics
last name: Rachel Makloski, RN
phone: 303-788-8300
phone ext: 1769
email: rmakloski@colocrm.com
facility: 
status: Recruiting
contact: 
country: United States
citation: Wallerstein R, Misra S, Dugar RB, Alem M, Mazzoni R, Garabedian MJ. Current knowledge of prenatal diagnosis of mosaic autosomal trisomy in amniocytes: karyotype/phenotype correlations. Prenat Diagn. 2015 Sep;35(9):841-7. doi: 10.1002/pd.4620. Epub 2015 Jun 23.
PMID: 25976239
citation: Victor AR, Tyndall JC, Brake AJ, Lepkowsky LT, Murphy AE, Griffin DK, McCoy RC, Barnes FL, Zouves CG, Viotti M. One hundred mosaic embryos transferred prospectively in a single clinic: exploring when and why they result in healthy pregnancies. Fertil Steril. 2019 Feb;111(2):280-293. doi: 10.1016/j.fertnstert.2018.10.019.
PMID: 30691630
responsible party type: Principal Investigator
investigator affiliation: Colorado Center for Reproductive Medicine
investigator full name: Mandy Katz-Jaffe
investigator title: Scientific and Genetics Director
mesh term: Infertility
sharing ipd: No