Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT05901467
Status:
TERMINATED
Last Update Posted:
2025-11-18
First Post:
2023-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Recall by Genotype: Neuropeptide Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MGHKisspeptinResearch@partners.org', 'phone': '617-726-1309', 'title': 'Stephanie Seminara', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.'}}, 'adverseEventsModule': {'timeFrame': 'From time of study consent until removal from study participation (approximately 2 months).', 'description': 'All participants were asked about new health symptoms at each visit.', 'eventGroups': [{'id': 'EG000', 'title': 'kisspeptin, GnRH', 'description': 'IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory infection', 'notes': 'The primary healthcare team of the participant informed the study team of this adverse event. The event was determined to be grade 1 and unrelated to study interventions.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Endogenous LH Pulse Amplitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'kisspeptin, GnRH', 'description': 'IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.'}], 'paramType': 'MEAN', 'timeFrame': 'Hours 0-8', 'description': 'Average amplitude of LH pulses at baseline', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.'}, {'type': 'PRIMARY', 'title': 'Kisspeptin-induced LH Pulse Amplitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'kisspeptin, GnRH', 'description': 'IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.'}], 'paramType': 'MEAN', 'timeFrame': 'Hours 8-11', 'description': 'Amplitude of LH pulse in response to kisspeptin', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'kisspeptin, GnRH', 'description': 'IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'Boston area. 16 participants were consented and screened for eligibility between 10/2023 and 4/2024.', 'preAssignmentDetails': 'There was no washout or run-in period. 4 individuals were found to be ineligible by criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Kisspeptin, GnRH', 'description': 'IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.'}], 'measures': [{'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-31', 'size': 228767, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-31T15:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'The study team no longer has access to GnRH. The study has been altered to account for this change and is no longer a clinical trial.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2023-05-31', 'resultsFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-03', 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endogenous LH Pulse Amplitude', 'timeFrame': 'Hours 0-8', 'description': 'Average amplitude of LH pulses at baseline'}, {'measure': 'Kisspeptin-induced LH Pulse Amplitude', 'timeFrame': 'Hours 8-11', 'description': 'Amplitude of LH pulse in response to kisspeptin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['reproductive disorders', 'kisspeptin', 'infertility', 'GnRH'], 'conditions': ['Reproductive Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this protocol is to assess response to kisspeptin and gonadotropin-releasing hormone (GnRH) stimulation testing as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals who carry variants in genes related to infertility.', 'detailedDescription': 'Assignment: All study subjects will undergo the same interventions. Individuals at high risk for infertility (i.e., carry variants in genes related to infertility) will be compared to controls (i.e., those who do not carry variants in genes related to infertility).\n\nDelivery of Interventions:\n\n* Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.\n* On the day of the study, the subjects will have an intravenous (IV) line placed and\n\n * Undergo up to q10 min blood sampling x 12 hours\n * Receive a single kisspeptin IV bolus at hour 8\n * Receive a single GnRH IV bolus at hour 11'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No prescription medications that could interfere with hypothalamic reproductive function\n* No illicit drug use\n* No excessive alcohol consumption (more than 10 drinks/week)\n* No history of an allergic medication reaction requiring emergency medical care\n* Normal blood pressure reading (systolic blood pressure \\< 140 mm Hg, diastolic \\< 90 mm Hg)\n* White blood cell, platelet counts, prolactin, and thyroid-stimulating hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range\n* Normal hemoglobin\n* Blood urea nitrogen (BUN), creatinine not elevated\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) within 3 times upper limit of normal\n* Enrolled in the Partners HealthCare Biobank and genotypically characterized\n* For women\n\n * No oral contraceptives for at least 1 month\n * No contraceptive implants for at least 3 months\n * Not breastfeeding and not pregnant\n * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration)'}, 'identificationModule': {'nctId': 'NCT05901467', 'briefTitle': 'Recall by Genotype: Neuropeptide Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Recall by Genotype: Neuropeptide Stimulation', 'orgStudyIdInfo': {'id': '326733'}, 'secondaryIdInfos': [{'id': 'P50HD104224', 'link': 'https://reporter.nih.gov/quickSearch/P50HD104224', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'kisspeptin, GnRH', 'description': 'IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.', 'interventionNames': ['Drug: kisspeptin 112-121', 'Drug: GnRH']}], 'interventions': [{'name': 'kisspeptin 112-121', 'type': 'DRUG', 'otherNames': ['metastin 45-54'], 'description': 'One IV bolus of kisspeptin 112-121', 'armGroupLabels': ['kisspeptin, GnRH']}, {'name': 'GnRH', 'type': 'DRUG', 'otherNames': ['gonadotropin-releasing hormone'], 'description': 'One IV bolus of gonadotropin-releasing hormone', 'armGroupLabels': ['kisspeptin, GnRH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Stephanie B Seminara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stephanie B. Seminara, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine', 'investigatorFullName': 'Stephanie B. Seminara, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}