Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-04 @ 3:51 PM
Study NCT ID:
NCT03387059
Status:
TERMINATED
Last Update Posted:
2019-09-24
First Post:
2017-12-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@emdgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Communication Center', 'organization': 'Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early, due to the poor feasibility and sustainability, leading to slow recruitment rate.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Day 152', 'eventGroups': [{'id': 'EG000', 'title': 'Forielle Endometrial Washing', 'description': 'Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Endometrial Washing', 'description': 'Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Implantation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forielle Endometrial Washing', 'description': 'Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}, {'id': 'OG001', 'title': 'No Endometrial Washing', 'description': 'Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}], 'timeFrame': 'Post Embryo Transfer (PET) Days 21 to 28', 'description': 'Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive and Negative Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forielle Endometrial Washing', 'description': 'Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}, {'id': 'OG001', 'title': 'No Endometrial Washing', 'description': 'Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}], 'timeFrame': 'At Post Embryo Transfer (PET) Day 14', 'description': 'Positive and Negative Pregnancy measured by Day 14 serum beta Human chorionic gonadotropin (Beta-HCG) pregnancy test.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Confirmed Ongoing Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forielle Endometrial Washing', 'description': 'Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}, {'id': 'OG001', 'title': 'No Endometrial Washing', 'description': 'Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}], 'timeFrame': 'Post Embryo Transfer (PET) Days 70 to 84', 'description': 'Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by obstetric ultrasound (transvaginal or abdominal).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Device Incidents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forielle Endometrial Washing', 'description': 'Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}, {'id': 'OG001', 'title': 'No Endometrial Washing', 'description': 'Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}], 'timeFrame': 'Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84', 'description': 'A medical device incident is any malfunction or deterioration in the characteristics and/or clinical performance of a device, as well as any inadequacy in the labelling or the instructions for use (IFU) which, directly or indirectly, might lead to or might have led to the death of a participant, or user or of other persons or to a serious deterioration in their state of health.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Forielle Endometrial Washing', 'description': 'Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}, {'id': 'FG001', 'title': 'No Endometrial Washing', 'description': 'Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Nine participants were enrolled and the study was prematurely terminated due to the poor feasibility and sustainability, leading to slow recruitment rate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Forielle Endometrial Washing', 'description': 'Participants randomized in this group were assessed using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}, {'id': 'BG001', 'title': 'No Endometrial Washing', 'description': 'Participants randomized in this group (Control) were assessed without using Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomization).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-Treat (ITT) population included all randomized participants into the trial.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-09', 'size': 15931086, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-23T09:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'The study was terminated early, due to the poor feasibility and sustainability, leading to slow recruitment rate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-23', 'studyFirstSubmitDate': '2017-12-22', 'resultsFirstSubmitDate': '2019-06-03', 'studyFirstSubmitQcDate': '2017-12-22', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-23', 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation Rate', 'timeFrame': 'Post Embryo Transfer (PET) Days 21 to 28', 'description': 'Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Positive and Negative Pregnancy', 'timeFrame': 'At Post Embryo Transfer (PET) Day 14', 'description': 'Positive and Negative Pregnancy measured by Day 14 serum beta Human chorionic gonadotropin (Beta-HCG) pregnancy test.'}, {'measure': 'Number of Participants With Confirmed Ongoing Pregnancy', 'timeFrame': 'Post Embryo Transfer (PET) Days 70 to 84', 'description': 'Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by obstetric ultrasound (transvaginal or abdominal).'}, {'measure': 'Number of Participants With Device Incidents', 'timeFrame': 'Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84', 'description': 'A medical device incident is any malfunction or deterioration in the characteristics and/or clinical performance of a device, as well as any inadequacy in the labelling or the instructions for use (IFU) which, directly or indirectly, might lead to or might have led to the death of a participant, or user or of other persons or to a serious deterioration in their state of health.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infertility', 'Forielle', 'Assisted Reproductive Technique (ART)', 'Controlled Ovarian Stimulation (COS)'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial condition to implantation after Controlled Ovarian Stimulation (COS) during Assisted Reproductive Technique (ART).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '41 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All infertile women treated with intracytoplasmic sperm injection (ICSI)/Fertilization in Vitro and Embryo Transfer (FIVET)\n* Less than or equal to (\\<=) 1 previous failed embryo transfer\n* Eumenorrheic normo-gonadotropic women\n* Basal follicle-stimulating hormone (FSH) \\<=12 International unit per liter (IU/L)\n* Anti-mullerian hormone (AMH) greater than (\\>) 1.1 nanogram per milliliter (ng/mL)\n* Ovarian Reserve: number of antral follicles 2 millimeter (mm) between 6 \\<= antral follicle count (AFC) \\<= 16\n* Follicles \\> 16 mm at the triggering day between 5-14\n* Body Mass Index (BMI) between 18 \\<= BMI \\<= 27 kilogram per meter square (kg/m\\^2)\n* Indication for Fresh Embryo transfer\n* Normal uterine cavity on ultrasound exam (e.g., no presence of hydrosalpinx)\n* Undergoing Assisted Reproductive Technique (ART) and oocyte maturation by human chorionic gonadotropin (HCG) triggering\n* Progesterone (P4) serum level at the HCG triggering day \\<= 1.5 ng/mL (Day O/Randomization)\n* Estradiol (E2) \\<= 3000 picogram/milliliter (pg/mL) at the human chorionic gonadotropin (HCG) triggering day (Day 0/Randomization)\n* Subjects must have read and signed the Informed Consent Form prior to study-specific-procedures not part of standard of care\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Clinically significant systemic disease (such as diabetes, metabolic syndrome, immunological diseases, diagnosed thrombophilia, porphyria, or any other medical condition requiring the use of low-molecular weight heparin therapy)\n* Polycystic ovary syndrome (PCOS) according to Rotterdam Consensus Criteria (European Society of Human Reproduction and Embryology \\[ESHRE\\]/American Society for Reproductive Medicine \\[ASRM\\], 2003)\n* Poor ovarian response (POR) according to the European Society of Human Reproduction and Embryology (ESHRE) Criteria\n* RIF (repeated implantation failure), defined as greater than or equals to (\\>=) 2 previous failed embryo transfers\n* Endometriosis III-IV stage or adenomyosis\n* Clinically significant findings on exam or ultrasound, such as salpingitis, hydrosalpynx or evidence of ovarian cysts\n* Known hypersensitivity to any of the components of the solution\n* Known hypersensitivity to vaginal progesterone or its excipients\n* Other protocol defined exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03387059', 'acronym': 'ENDOMEDE', 'briefTitle': 'Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Multicentre, Prospective Randomised Controlled, Interventional Clinical Investigation to Assess the Clinical Safety and Performance of Forielle, a Medical Device for Endometrial Washing in Restoring Favorable Endometrial Condition to Implantation After COS During Assisted Reproductive Practice (ENDOMEDE)', 'orgStudyIdInfo': {'id': 'MS700623-0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Forielle Endometrial Washing', 'interventionNames': ['Device: Forielle']}, {'type': 'NO_INTERVENTION', 'label': 'No Endometrial Washing'}], 'interventions': [{'name': 'Forielle', 'type': 'DEVICE', 'description': 'Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).', 'armGroupLabels': ['Forielle Endometrial Washing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47841', 'city': 'Cattolica', 'country': 'Italy', 'facility': 'Unità Operativa di Fisiopatologia della Riproduzione - Ospedale Cervesi di Cattolica', 'geoPoint': {'lat': 43.96182, 'lon': 12.73631}}, {'zip': '50100', 'city': 'Florence', 'country': 'Italy', 'facility': 'Centro di Procreazione Assistita Demetra', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '55041', 'city': 'Lucca', 'country': 'Italy', 'facility': 'Centro di Procreazione Medicalmente Assistita - Ospedale di Versilia', 'geoPoint': {'lat': 43.84369, 'lon': 10.50447}}, {'zip': '20089', 'city': 'Milan', 'country': 'Italy', 'facility': 'Humanitas Fertility Center', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Scienze della Natalità - IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20052', 'city': 'Monza', 'country': 'Italy', 'facility': 'Unità Operativa di Ginecologia - Istituti Clinici Zucchi', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Centro di Procreazione Medicalmente Assistita (PMA) - Casa di Cura PROMEA', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono S.P.A., Italy', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}