Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT01978561
Status:
COMPLETED
Last Update Posted:
2015-09-14
First Post:
2013-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-10', 'studyFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2013-11-01', 'lastUpdatePostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of live births', 'timeFrame': 'Within approximately 7 months after NT-03'}], 'secondaryOutcomes': [{'measure': 'Number of stillbirths', 'timeFrame': 'Within approximately 7 months after study NT-03'}, {'measure': 'Number of spontaneous abortions (miscarriages)', 'timeFrame': 'Within approximately 7 months after study NT-03'}, {'measure': 'Number of congenital anomalies', 'timeFrame': 'Up to 4 weeks after birth'}, {'measure': 'Number of severe neonatal adverse events', 'timeFrame': 'Up to 4 weeks after birth'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Repeated IVF Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.thriveivf.com', 'label': 'Study NT-03, Thrive-IVF Research Study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.', 'detailedDescription': 'NT-04 is a follow-up study that will include subjects who received at least one dose of study drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03. NT-04 does not involve the administration of study drug treatment.\n\nIn NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in NT-04.\n\nSubjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of gestation, at which time subjects will be contacted every two weeks until confirmation of delivery. Information about pregnancy status and use of prescription medications will be collected at these telephone interviews.\n\nBetween Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.\n\nFollowing delivery, additional information will be obtained, including pregnancy outcome, gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn assessment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one dose of study drug administered in NT-03\n* Ongoing clinical pregnancy at Week 10 of gestation\n* Able and willing to enroll in NT-04\n\nExclusion Criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT01978561', 'acronym': 'Thrive-IVF F/U', 'briefTitle': 'Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nora Therapeutics, Inc.'}, 'officialTitle': 'Pregnancy, Delivery, And Neonatal Outcomes In Subjects With Ongoing Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)', 'orgStudyIdInfo': {'id': 'NT-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Follow-Up after dosing with NT100 Dose 1', 'description': 'Follow-Up after dosing with NT100 Dose 1', 'interventionNames': ['Biological: Post dosing with NT100']}, {'type': 'EXPERIMENTAL', 'label': 'Follow-Up after dosing with NT100 Dose 2', 'description': 'Follow-Up after dosing with NT100 Dose 2', 'interventionNames': ['Biological: Post dosing with NT100']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Follow-Up after dosing with Placebo', 'description': 'Follow-Up after dosing with Placebo', 'interventionNames': ['Other: Post dosing with Placebo']}], 'interventions': [{'name': 'Post dosing with NT100', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Follow-Up after dosing with NT100 Dose 1', 'Follow-Up after dosing with NT100 Dose 2']}, {'name': 'Post dosing with Placebo', 'type': 'OTHER', 'armGroupLabels': ['Follow-Up after dosing with Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nora Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}