Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04472156
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2020-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Study of a Mosaic Embryo Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Outcomes will be evaluated with women who have a mosaic embryo transferred'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Implantation rate', 'timeFrame': '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', 'timeFrame': '9-12 months post embryo transfer', 'description': 'Live birth rate will be evaluated'}], 'secondaryOutcomes': [{'measure': 'Miscarriage Rates', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '25976239', 'type': 'BACKGROUND', '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': '30691630', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT04472156', 'briefTitle': 'A Prospective Study of a Mosaic Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Colorado Center for Reproductive Medicine'}, 'officialTitle': 'A Prospective Study of a Mosaic Embryo Transfer', 'orgStudyIdInfo': {'id': 'Mosaic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transfer of mosaic embryo', '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.', 'interventionNames': ['Procedure: Transfer of mosaic embryo']}], 'interventions': [{'name': 'Transfer of mosaic embryo', 'type': 'PROCEDURE', 'description': 'Subjects will transfer a mosaic embryo transferred to their uterus', 'armGroupLabels': ['Transfer of mosaic embryo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Makloski, RN', 'role': 'CONTACT', 'email': 'TriggerStudy@colocrm.com'}], 'facility': 'Colorado Center for Reproductive Medicine', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}], 'centralContacts': [{'name': 'Rachel Makloski, RN', 'role': 'CONTACT', 'email': 'rmakloski@colocrm.com', 'phone': '303-788-8300', 'phoneExt': '1769'}], 'overallOfficials': [{'name': 'Mandy Katz-Jaffe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fertility Genetics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colorado Center for Reproductive Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientific and Genetics Director', 'investigatorFullName': 'Mandy Katz-Jaffe', 'investigatorAffiliation': 'Colorado Center for Reproductive Medicine'}}}}