Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT06179420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2023-12-10', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total cumulative dosage of Gonadotropins', 'timeFrame': 'for 1 year duration', 'description': 'number of total dosage that utilize during one cycle of IVF treatment'}, {'measure': 'Total number of matured oocytes', 'timeFrame': 'for 1 year duration', 'description': 'number of matured oocytes following the stimulation protocol'}, {'measure': 'total number of good quality blastocyst', 'timeFrame': 'for 1 year duration', 'description': 'total blastocyst achieved after each sti,ulation protocol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fertility Issues']}, 'referencesModule': {'references': [{'pmid': '34493094', 'type': 'RESULT', 'citation': 'Leahy BD, Racowsky C, Needleman D. Inferring simple but precise quantitative models of human oocyte and early embryo development. J R Soc Interface. 2021 Sep;18(182):20210475. doi: 10.1098/rsif.2021.0475. Epub 2021 Sep 8.'}, {'pmid': '30088950', 'type': 'RESULT', 'citation': 'Simopoulou M, Sfakianoudis K, Antoniou N, Maziotis E, Rapani A, Bakas P, Anifandis G, Kalampokas T, Bolaris S, Pantou A, Pantos K, Koutsilieris M. Making IVF more effective through the evolution of prediction models: is prognosis the missing piece of the puzzle? Syst Biol Reprod Med. 2018 Oct;64(5):305-323. doi: 10.1080/19396368.2018.1504347. Epub 2018 Aug 8.'}, {'pmid': '34256948', 'type': 'RESULT', 'citation': 'Hariton E, Chi EA, Chi G, Morris JR, Braatz J, Rajpurkar P, Rosen M. A machine learning algorithm can optimize the day of trigger to improve in vitro fertilization outcomes. Fertil Steril. 2021 Nov;116(5):1227-1235. doi: 10.1016/j.fertnstert.2021.06.018. Epub 2021 Jul 10.'}, {'pmid': '36096871', 'type': 'RESULT', 'citation': 'Fanton M, Nutting V, Rothman A, Maeder-York P, Hariton E, Barash O, Weckstein L, Sakkas D, Copperman AB, Loewke K. An interpretable machine learning model for individualized gonadotrophin starting dose selection during ovarian stimulation. Reprod Biomed Online. 2022 Dec;45(6):1152-1159. doi: 10.1016/j.rbmo.2022.07.010. Epub 2022 Jul 28.'}, {'pmid': '35915001', 'type': 'RESULT', 'citation': 'Correa N, Cerquides J, Arcos JL, Vassena R. Supporting first FSH dosage for ovarian stimulation with machine learning. Reprod Biomed Online. 2022 Nov;45(5):1039-1045. doi: 10.1016/j.rbmo.2022.06.010. Epub 2022 Jun 18.'}, {'pmid': '33160514', 'type': 'RESULT', 'citation': 'Curchoe CL, Flores-Saiffe Farias A, Mendizabal-Ruiz G, Chavez-Badiola A. Evaluating predictive models in reproductive medicine. Fertil Steril. 2020 Nov;114(5):921-926. doi: 10.1016/j.fertnstert.2020.09.159.'}]}, 'descriptionModule': {'briefSummary': 'This prospective study is subject to approval of institutional medical research ethics committee. Patient undergoing second cycle IVF will be enrolled into the intervention group. Intervention involved using a clinical decision support tool, Opt-IVF to guide gonadotrophins dosing and trigger dates for a personalized controlled ovarian stimulation cycle based on the distribution of follicle sizes on day 1 and day 5, and hormone dosages given on day 1 to 4.\n\nPatients will undergo transvaginal ultrasound exam on day 1 and day 5 of the cycle to determine the number and size of follicles present. The data is used in the Opt-IVF decision support tool to suggest Gonadotropin dosage for D5 and beyond and to recommend the antagonist start day and trigger day.\n\nClinical investigators will not override the Opt-IVF recommended dosage in any patients.', 'detailedDescription': 'The total dosage of gonadotrophin, number of good quality oocytes and blastocyst will be analyzed from each arm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who had failed their first IVF treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing 2nd cycle of IVF\n\nExclusion Criteria:\n\n* Polycystic ovarian syndrome patient'}, 'identificationModule': {'nctId': 'NCT06179420', 'briefTitle': 'The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': 'The Effectiveness of Advanced Decision Support Tool (OPT-IVF) for IVF Treatment', 'orgStudyIdInfo': {'id': 'UKMPPI/111/8/JEP-2023-735'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'standard IVF regime protocol based on clinician decision', 'description': 'The dosage of gonadotrophin and time of transvaginal ultrasound decided by clinician', 'interventionNames': ['Other: total cumulative gonadotrophin usage']}, {'label': 'clinical decision support tool, Opt-IVF for IVF regime protocol', 'description': 'The dosage of gonadotrophin and time of transvaginal ultrasound decided by a clinical decision support tool ( OPt -IVF)', 'interventionNames': ['Other: total cumulative gonadotrophin usage']}], 'interventions': [{'name': 'total cumulative gonadotrophin usage', 'type': 'OTHER', 'otherNames': ['number of matured oocytes', 'number of qood quality blastocyst'], 'description': 'total dosage in IU', 'armGroupLabels': ['clinical decision support tool, Opt-IVF for IVF regime protocol', 'standard IVF regime protocol based on clinician decision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Advanced Reproductive Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Muhammad Azrai Abu', 'role': 'CONTACT', 'email': 'azraiabu1983@gmail.com', 'phone': '+60196410944'}], 'overallOfficials': [{'name': 'Muhammad Azrai Abu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department Of Obstetrics And Gynecology, Ukm Medical Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Prof', 'investigatorFullName': 'Azrai Abu', 'investigatorAffiliation': 'National University of Malaysia'}}}}