Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-28 @ 9:18 AM
Study NCT ID:
NCT06141135
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2023-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Allocation information will be handled by embryology team at BIVF.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing Pregnancy Rate', 'timeFrame': 'Up to 2 years', 'description': 'The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer.'}], 'secondaryOutcomes': [{'measure': 'Miscarriage Rate', 'timeFrame': 'Up to 2 years', 'description': 'Number of participants that experience a pregnancy loss after the 1st embryo transfer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'referencesModule': {'references': [{'pmid': '29566854', 'type': 'BACKGROUND', 'citation': 'Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Electronic address: ASRM@asrm.org; Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. The use of preimplantation genetic testing for aneuploidy (PGT-A): a committee opinion. Fertil Steril. 2018 Mar;109(3):429-436. doi: 10.1016/j.fertnstert.2018.01.002.'}, {'pmid': '22551456', 'type': 'BACKGROUND', 'citation': 'Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24.'}, {'pmid': '23548942', 'type': 'BACKGROUND', 'citation': 'Forman EJ, Hong KH, Ferry KM, Tao X, Taylor D, Levy B, Treff NR, Scott RT Jr. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril. 2013 Jul;100(1):100-7.e1. doi: 10.1016/j.fertnstert.2013.02.056. Epub 2013 Mar 30.'}, {'pmid': '23731996', 'type': 'BACKGROUND', 'citation': 'Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The GETSET trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (PGT-A) in elective single embryo transfer in women between 35 and 40 years of age.', 'detailedDescription': 'In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF center will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants.\n\nOnly patients with at least one evaluable blastocyst will be randomized. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by IVF center.\n\nIn the control arm, patients will undergo a single frozen embryo transferof the untested, best quality blastocyst. All other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. PGT-A results of the untransferred embryos will be revealed to the patient AFTER the outcome of the initial ET is known.\n\nIn the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and PGT-A. PGT-A will be performed regardless of the number of blastocysts available. Patients will undergo frozen transfer of the single, best quality euploid blastocyst. If the initial transfer results in a non-conception cycle and additional embryos are available for transfer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing IVF of between 35 and 40 years of age at IVF cycle start\n* Utilization of Intracytoplasmic Sperm Injection ICSI (recommended) or ---Traditional IVF\n* Utilization of ejaculated or testicular sperm\n* Utilization of autologous or donor sperm\n* All Controlled Ovarian Hyperstimulation (COH) protocols\n\nExclusion Criteria:\n\n* Utilization of donor oocytes\n* Utilization of gestational carrier\n* Recurrent Pregnancy Loss (RPL) defined as ≥ 3 consecutive miscarriages\n* Recurrent Implantation Failure (RIF) defined as ≥ 3 more failed embryo transfers\n* Preimplantation genetic testing for monogenic/single gene disorders (PGT-M)\n* Translocation carriers'}, 'identificationModule': {'nctId': 'NCT06141135', 'acronym': 'GETSET', 'briefTitle': 'GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genomic Prediction Inc.'}, 'officialTitle': 'GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'GPCL 20232892'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm - Transfer of Best Quality, Euploid Blastocyst', 'description': 'Transfer of best quality, PGTA normal (euploid) blastocyst.', 'interventionNames': ['Other: Preimplantation genetic testing for aneuploidy (PGTA)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm - Transfer of Untested, Best Quality Blastocyst', 'description': 'Transfer of Untested, Best Quality Blastocyst'}], 'interventions': [{'name': 'Preimplantation genetic testing for aneuploidy (PGTA)', 'type': 'OTHER', 'description': '24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage)', 'armGroupLabels': ['Experimental Arm - Transfer of Best Quality, Euploid Blastocyst']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristin Rooney', 'role': 'CONTACT', 'email': 'krooney@bivf.com', 'phone': '(781) 434-6500'}, {'name': 'Kim Thorton, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boston IVF', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}], 'centralContacts': [{'name': 'Talia Metzgar', 'role': 'CONTACT', 'email': 'talia@genomicprediction.com', 'phone': '(973) 529- 4223'}, {'name': 'Kristin Rooney', 'role': 'CONTACT', 'email': 'krooney@bostonivf.com', 'phone': '(781) 434-6500'}], 'overallOfficials': [{'name': 'Nathan Treff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Genomic Prediction Clinical Labortory'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genomic Prediction Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Boston IVF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}