Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-26 @ 5:55 AM
Study NCT ID:
NCT02310802
Status:
COMPLETED
Last Update Posted:
2017-10-23
First Post:
2014-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2017-09-21', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-20', 'studyFirstSubmitDate': '2014-11-19', 'dispFirstSubmitQcDate': '2017-09-21', 'studyFirstSubmitQcDate': '2014-12-04', 'dispFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SAFETY ENDPOINTS Treatment emergent adverse events frequency and severity', 'timeFrame': 'up to 10 weeks post OPU day', 'description': 'Treatment emergent adverse events frequency and severity'}, {'measure': 'SAFETY ENDPOINTS (Haematology and biochemistry assessments)', 'timeFrame': '14 days post OPU day', 'description': 'Haematology and biochemistry assessments at screening and at visit V3 (14 days post OPU day)'}, {'measure': 'PHARMACOKINETIC ENDPOINTS Plasma levels of OBE001', 'timeFrame': 'at 3.5 hours after dose administration', 'description': 'Plasma levels of OBE001'}, {'measure': 'PHARMACOKINETIC-PHARMACODYNAMIC ENDPOINTS :Uterine contractions relationship to OBE001 plasma levels and pregnancy rate', 'timeFrame': 'up 10 weeks post OPU day', 'description': 'Uterine contractions relationship to OBE001 plasma levels and pregnancy rate'}], 'primaryOutcomes': [{'measure': 'EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat', 'timeFrame': 'about 6 weeks post ET day', 'description': 'Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day.'}], 'secondaryOutcomes': [{'measure': 'EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test', 'timeFrame': '14 days post OPU day', 'description': 'Percentage of women with positive blood pregnancy test at 14 days post OPU day.'}, {'measure': 'EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat', 'timeFrame': '10 weeks post OPU day', 'description': 'Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at 10 weeks post OPU day.'}, {'measure': 'EFFICACY ENDPOINTS The embryo-implantation rate', 'timeFrame': '6 weeks post ET day', 'description': 'The embryo-implantation rate defined as the number of intra-uterine embryos with positive heart-beat at 6 weeks post ET day divided by the number of embryos transferred'}, {'measure': 'EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions', 'timeFrame': 'at 3.5 hours after dose administration', 'description': 'Change from baseline to the time of ET in the rate of uterine contractions (UC/min).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IVF', 'ICSI'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '33534895', 'type': 'DERIVED', 'citation': 'Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.', 'detailedDescription': 'The study is a prospective, dose-finding, randomised, parallel group, double-blind, placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor antagonist OBE001 in 240 women undergoing embryo transfer following IVF or ICSI.\n\nThe four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria\n\n1. Women with medically indicated IVF or ICSI using her own oocytes.\n2. GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.\n3. Evidence of uterine contractions by transvaginal ultrasound at baseline.\n\nKey Exclusion Criteria\n\n1. Blastocyst stage or frozen-thaw transfers\n2. Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results\n3. Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome'}, 'identificationModule': {'nctId': 'NCT02310802', 'acronym': 'IMPLANT', 'briefTitle': 'OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI', 'organization': {'class': 'INDUSTRY', 'fullName': 'ObsEva SA'}, 'officialTitle': 'A Phase 2, Double-blind, Dose-finding, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of OBE001 to Improve Embryo Implantation Following IVF or ICSI', 'orgStudyIdInfo': {'id': '14-OBE001-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OBE001 dose 1', 'interventionNames': ['Drug: OBE001 dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'OBE001 dose 2', 'interventionNames': ['Drug: OBE001 dose 2']}, {'type': 'EXPERIMENTAL', 'label': 'OBE001 dose 3', 'interventionNames': ['Drug: OBE001 dose 3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'OBE001 dose 1', 'type': 'DRUG', 'description': 'OBE001 dispersible tablets for single oral administration', 'armGroupLabels': ['OBE001 dose 1']}, {'name': 'OBE001 dose 2', 'type': 'DRUG', 'description': 'OBE001 dispersible tablets for single oral administration', 'armGroupLabels': ['OBE001 dose 2']}, {'name': 'OBE001 dose 3', 'type': 'DRUG', 'description': 'OBE001 dispersible tablets for single oral administration', 'armGroupLabels': ['OBE001 dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo dispersible tablets for single oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Hradev Kralove', 'country': 'Czechia'}, {'city': 'Olomouc', 'country': 'Czechia', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Zlín', 'country': 'Czechia', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'city': 'Copenhagen', 'country': 'Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Hvidovre', 'country': 'Denmark', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Szczecin', 'country': 'Poland', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Alicante', 'country': 'Spain', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barakaldo', 'country': 'Spain', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bilbao', 'country': 'Spain', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'Seville', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Vigo', 'country': 'Spain', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ObsEva SA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ObsEva SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}