Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-03-10 @ 7:27 PM
Study NCT ID:
NCT01864356
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2013-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2013-05-14', 'studyFirstSubmitQcDate': '2013-05-24', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing clinical pregnancy rate', 'timeFrame': 'Week 8 of gestation', 'description': 'The primary efficacy outcome measure is the ongoing clinical pregnancy rate at Week 8 of gestation.'}], 'secondaryOutcomes': [{'measure': 'Biochemical evidence of pregnancy rate (as measured by hCG)', 'timeFrame': 'Week 4 of gestation'}, {'measure': 'Ongoing clinical pregnancy rate', 'timeFrame': 'Weeks 6 and 10 of gestation'}, {'measure': 'Implantation rate following embryo transfer', 'timeFrame': 'Week 8 of gestation'}, {'measure': 'Number of subjects with adverse events and serious adverse events', 'timeFrame': 'through 4 weeks after last dose of study drug (up to Week 10 of gestation)'}, {'measure': 'Changes in clinical laboratory parameters following study drug exposure', 'timeFrame': 'through 4 weeks after the last dose of study drug (up to Week 10 of gestation)'}, {'measure': 'Moderate to severe ovarian hyperstimulation syndrome (OHSS) rate', 'timeFrame': 'through Week 10 of gestation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IVF failure', 'Repeated IVF failure', 'Implantation failure', 'Repeated implantation failure', 'IVF', 'NT100'], 'conditions': ['Repeated IVF Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a history of repeated IVF failures.', 'detailedDescription': 'NT-03 will be a randomized, double blind, multi-center, placebo controlled study of multiple doses of subcutaneous NT100 following IVF in women with a history of repeated IVF failures. Approximately 150 subjects will be randomized in a 1:1:1 ratio to receive subcutaneous NT100 low dose, NT100 high dose, or placebo, qd for up to 4 weeks.\n\nScreening will include a standard IVF stimulation protocol, followed by fertilization and culture of embryos. If the subject remains eligible, she will be randomized to receive study drug. All subjects will be followed for 4 weeks after the last dose of study drug. At Week 10 of gestation, subjects who are pregnant will roll over into a follow-up study (NT-04) to assess subsequent pregnancy, delivery, and neonatal outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-menopausal female 21-38 years of age at screening\n* History of repeated IVF failures despite transfer of good-quality embryos, defined as follows:\n* ...1) 3 or more IVF cycles involving transfer of at least two good-quality cleavage-stage embryos or at least one good-quality blastocyst (2010 SART (Society for Assisted Reproductive Technologies) grading criteria)that resulted in one of the following outcomes:\n* \\* .....a) no pregnancy\n* \\* .....b) biochemical pregnancy\n* \\* .....c) spontaneous abortion of an intrauterine clinical pregnancy before or equal to completed Week 8 of gestation\n* ...2) At least two of the eligible IVF failures must have involved transfer of fresh embryos\n* ...3) At least two of the eligible IVF failures must have involved retrieval of at least 5 oocytes\n* ...4) No live birth, abortion later than Week 8 of gestation, or stillbirth may have occurred since the first of these IVF failures\n* Body mass index (BMI) of 19-38 kg per m2 at screening\n* TSH (thyroid-stimulating hormone) less than or equal to 4.0 mIU/L(milli-International units per Liter) for subjects with no history of hypothyroidism, or TSH less than or equal to 2.5 mIU/L for subjects with a history of hypothyroidism, at screening\n\nExclusion Criteria:\n\n* Prior diagnosis of moderate or severe ovarian hyperstimulation syndrome (OHSS)\n* Clinically confirmed polycystic ovary syndrome (PCOS)\n* History of a major congenital anomaly in the subject, her current male partner, or first degree relative of either the subject or her current male partner\n* Known karyotype abnormalities in either the subject or her current male partner / sperm donor\n* Any prior pregnancy terminated for a fetal medical condition\n* History of severe (stage IV) endometriosis\n* Current or past systemic autoimmune disease\n* Any uncontrolled clinically significant medical condition (e.g. asthma, Type II diabetes, infection)'}, 'identificationModule': {'nctId': 'NCT01864356', 'acronym': 'Thrive-IVF', 'briefTitle': 'A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nora Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double Blind, Multi-Center, Placebo Controlled Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Doses Of NT100 Following IVF In Women With A History Of Repeated IVF Failures (Thrive-IVF)', 'orgStudyIdInfo': {'id': 'NT-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NT100 Dose 1', 'description': 'NT100 Dose 1', 'interventionNames': ['Drug: NT100']}, {'type': 'EXPERIMENTAL', 'label': 'NT100 Dose 2', 'description': 'NT100 Dose 2', 'interventionNames': ['Drug: NT100']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NT100', 'type': 'DRUG', 'armGroupLabels': ['NT100 Dose 1', 'NT100 Dose 2']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'HRC Fertility', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'HRC Fertility', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'HRC Fertility', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Reproductive Associates of Delaware', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Columbia Fertility Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Fertility Institute', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'IVF and Fertility Center of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Reproductive Specialists', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Fertility Centers of Illinois / River North IVF Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60035', 'city': 'Highland Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Fertility Centers of Illinois / Highland Park IVF Center', 'geoPoint': {'lat': 42.18169, 'lon': -87.80034}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Shady Grove Fertility', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston IVF', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45209', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Institute for Reproductive Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Main Line Fertility Center', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '76022', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Assisted Reproduction', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '77063', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Fertility Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Center of Reproductive Medicine', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '84062', 'city': 'Pleasant Grove', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Fertility Center', 'geoPoint': {'lat': 40.36412, 'lon': -111.73854}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nora Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}