[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04472156":3,"trial-entities:NCT04472156":115,"trial-summary:NCT04472156":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":42,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":80,"locations":82,"central_contacts":96,"overall_officials":101,"references":106,"see_also_links":114},"NCT04472156","Mosaic","A Prospective Study of a Mosaic Embryo Transfer","RECRUITING","2026-12-15","2024-02","2024-02-29","2020-10-15","Colorado Center for Reproductive Medicine","OTHER",false,"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.",[18],"Infertility",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},250,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"PROCEDURE","Transfer of mosaic embryo","Subjects will transfer a mosaic embryo transferred to their uterus",[30],[34,38],{"measure":35,"description":36,"timeFrame":37},"Evaluation of Implantation rate","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","3-4 weeks after embryo transfer",{"measure":39,"description":40,"timeFrame":41},"Live birth rate","Live birth rate will be evaluated","9-12 months post embryo transfer",[43,47,51,54,57,60],{"measure":44,"description":45,"timeFrame":46},"Miscarriage Rates","The rate of miscarriage will be evaluated associated with a mosaic embryo transfer","5-12 months post embryo transfer",{"measure":48,"description":49,"timeFrame":50},"Products of conception from miscarriage","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.","2-9 months post embryo transfer",{"measure":52,"description":53,"timeFrame":41},"Pregnancy complications","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":55,"description":56,"timeFrame":41},"Stillbirth rates associated with Mosaic Embryo Transfer","The rate of stillbirths with will be evaluated among patients who have had a mosaic embryo transfer",{"measure":58,"description":59,"timeFrame":41},"Prenatal testing","If available, we will request any results of prenatal testing of karyotype that was obtained via Amniocentesis or Chorionic Villa Sampling (CVS)",{"measure":61,"description":62,"timeFrame":63},"Neonatal Outcomes","Patient will be contacted to assess the health of the infant, noting any medical problems if any that the baby has.","12-15 months after birth of baby","FEMALE","18 Years","45 Years",true,{"inclusion":69,"exclusion":73,"raw_text":79},[70,71,72],"Women age 18-45 Infertile women who have completed an IVF cycle with PGT at the Colorado Center for Reproductive Medicine (CCRM) that have a mosaic embryo","Patients can be of any race, culture, sexual orientation or ethnicity","Patients that are willing to transfer a single embryo",[74,75,76,77,78],"Patients that do not meet the clinical requirements for an embryo transfer per clinic standards.","Patients that desire more than a single embryo transfer.","Patients that are using a gestational carrier.","Embryonic mosaic PGT results that include chromosome errors 13, 18, 21","Patients that did not complete their IVF with PGT cycle at the Colorado Center for Reproductive Medicine.","Inclusion Criteria:\n\n* Women age 18-45 Infertile women who have completed an IVF cycle with PGT at the Colorado Center for Reproductive Medicine (CCRM) that have a mosaic embryo\n* Patients can be of any race, culture, sexual orientation or ethnicity\n* Patients that are willing to transfer a single embryo\n\nExclusion Criteria:\n\n* Patients that do not meet the clinical requirements for an embryo transfer per clinic standards.\n* Patients that desire more than a single embryo transfer.\n* Patients that are using a gestational carrier.\n* Embryonic mosaic PGT results that include chromosome errors 13, 18, 21\n* Patients that did not complete their IVF with PGT cycle at the Colorado Center for Reproductive Medicine.",[81],"ADULT",[83],{"facility":12,"status":7,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":93},"Lone Tree","Colorado","80124","United States",[89],{"name":90,"role":91,"email":92},"Rachel Makloski, RN","CONTACT","TriggerStudy@colocrm.com",{"lat":94,"lon":95},39.55171,-104.8863,[97],{"name":90,"role":91,"phone":98,"phoneExt":99,"email":100},"303-788-8300","1769","rmakloski@colocrm.com",[102],{"name":103,"affiliation":104,"role":105},"Mandy Katz-Jaffe, PhD","Fertility Genetics","PRINCIPAL_INVESTIGATOR",[107,111],{"pmid":108,"type":109,"citation":110},"25976239","BACKGROUND","Wallerstein R, Misra S, Dugar RB, Alem M, Mazzoni R, Garabedian MJ. Current knowledge of prenatal diagnosis of mosaic autosomal trisomy in amniocytes: karyotype\u002Fphenotype correlations. Prenat Diagn. 2015 Sep;35(9):841-7. doi: 10.1002\u002Fpd.4620. Epub 2015 Jun 23.",{"pmid":112,"type":109,"citation":113},"30691630","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\u002Fj.fertnstert.2018.10.019.",[],{"nct_id":4,"conditions":116,"biomarkers":117},[18],[],{"nct_id":4,"found":67,"summary":119,"prompt_version":129},{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study that plans to enroll 250 women. It is a prospective study, meaning researchers will follow participants forward in time.","completed","Study of Mosaic Embryo Transfer for Infertility","This study is looking at the results of transferring a \"mosaic embryo\" (an embryo with both normal and abnormal cells) into the uterus of women experiencing infertility. The goal is to see how often these embryos lead to a successful pregnancy and a live birth. You might be able to join if you are a woman between 18 and 45 years old, have completed an IVF cycle with genetic testing (PGT) at the Colorado Center for Reproductive Medicine (CCRM), and have a mosaic embryo that you are willing to transfer. The study will measure the implantation rate (how often the embryo attaches to the uterus) at 3-4 weeks and the live birth rate at 9-12 months after the embryo transfer. The current recruitment status is unclear.","Participants will be followed for 9-12 months after embryo transfer to assess live birth rates.",126,"You would undergo a procedure to transfer a mosaic embryo to your uterus. The study will evaluate implantation at 3-4 weeks and live birth at 9-12 months after the transfer.","Not stated in the trial record.",[],"v2"]