Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT03401918
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2018-01-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility
Sponsor:
Organization:
Raw JSON
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For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Control Patients', 'description': 'Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abnormal Microbiome Bacterial Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Recurrent Pregnancy Loss or Unexplained Infertility', 'description': 'Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.\n\nThose who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome.'}, {'id': 'OG001', 'title': 'Healthy Control Patients', 'description': 'Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.'}], 'timeFrame': '1 month', 'description': 'The primary outcome will abnormal microbiome results. An abnormal microbiome will be defined as less then 90% lactobacilli on DNA sequencing', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were analyzed because the assay failed validation and the results are uninterpretable.'}, {'type': 'PRIMARY', 'title': 'Abnormal Endometrial Receptivity Array', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Recurrent Pregnancy Loss or Unexplained Infertility', 'description': 'Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.\n\nThose who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome.'}, {'id': 'OG001', 'title': 'Healthy Control Patients', 'description': 'Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.'}], 'timeFrame': '1 month', 'description': 'The second primary outcome will be abnormal endometrial receptivity array defined as non-receptive (pre or post receptive) based on RNA sequencing of an endometrial gene array.', 'reportingStatus': 'POSTED', 'populationDescription': 'No endometrial receptivity array data were collected because the microbiome assay failed validation and further testing was not done.'}, {'type': 'PRIMARY', 'title': 'Normalized Microbiome Bacterial Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Recurrent Pregnancy Loss or Unexplained Infertility', 'description': 'Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.\n\nThose who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome.'}, {'id': 'OG001', 'title': 'Healthy Control Patients', 'description': 'Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.'}], 'timeFrame': '3-6 months', 'description': 'The primary outcome will be normal microbiome results defined as \\>90% lactobacilli after oral antibiotics and vaginal probiotics after initially abnormal microbiome results', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure as the study did not continue to the treatment phase.'}, {'type': 'PRIMARY', 'title': 'Normalized Endometrial Receptivity Array', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Recurrent Pregnancy Loss or Unexplained Infertility', 'description': 'Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.\n\nThose who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome.'}, {'id': 'OG001', 'title': 'Healthy Control Patients', 'description': 'Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.'}], 'timeFrame': '3-6 months', 'description': 'The primary outcome will be normal endometrial receptivity array results defined as receptive after luteal phase progesterone support after initially abnormal endometrial receptivity array results', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure as the study did not continue to the treatment phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Recurrent Pregnancy Loss or Unexplained Infertility', 'description': 'Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.\n\nThose who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome.'}, {'id': 'FG001', 'title': 'Healthy Control Patients', 'description': 'Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Recurrent Pregnancy Loss or Unexplained Infertility', 'description': 'Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.\n\nThose who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome.'}, {'id': 'BG001', 'title': 'Healthy Control Patients', 'description': 'Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.'}, {'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': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', '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': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2020-08-21', 'size': 260007, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-05T15:33', 'hasProtocol': True}, {'date': '2017-07-12', 'size': 331226, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-04T20:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-30', 'studyFirstSubmitDate': '2018-01-01', 'resultsFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-10', 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal Microbiome Bacterial Sequencing', 'timeFrame': '1 month', 'description': 'The primary outcome will abnormal microbiome results. An abnormal microbiome will be defined as less then 90% lactobacilli on DNA sequencing'}, {'measure': 'Abnormal Endometrial Receptivity Array', 'timeFrame': '1 month', 'description': 'The second primary outcome will be abnormal endometrial receptivity array defined as non-receptive (pre or post receptive) based on RNA sequencing of an endometrial gene array.'}, {'measure': 'Normalized Microbiome Bacterial Sequencing', 'timeFrame': '3-6 months', 'description': 'The primary outcome will be normal microbiome results defined as \\>90% lactobacilli after oral antibiotics and vaginal probiotics after initially abnormal microbiome results'}, {'measure': 'Normalized Endometrial Receptivity Array', 'timeFrame': '3-6 months', 'description': 'The primary outcome will be normal endometrial receptivity array results defined as receptive after luteal phase progesterone support after initially abnormal endometrial receptivity array results'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Pregnancy Loss', 'Unexplained Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if patients with recurrent pregnancy loss or unexplained infertility have an altered uterine gene expression or uterine microbiome (micro-organism composition) during the window of embryo implantation. Furthermore we would like to assess for women with an abnormal uterine gene expression whether vaginal progesterone medication improves or alters gene expression and for women with an abnormal microbiome whether antibiotic treatment followed by probiotic treatment normalizes the microbiome.', 'detailedDescription': "Recurrent pregnancy loss and unexplained infertility are emotional and difficult diagnoses. Despite a thorough medical investigation, many cases of recurrent pregnancy loss and infertility remain unexplained. Understanding endometrial factors that may contribute to these diseases may lead to improved treatment options in the future. The purpose of this study is to determine if patients with recurrent pregnancy loss or unexplained infertility have an altered uterine gene expression or uterine microbiome (micro-organism composition) during the window of embryo implantation. Furthermore we would like to assess for women with an abnormal uterine gene expression whether vaginal progesterone medication improves or alters gene expression and for women with an abnormal microbiome whether antibiotic treatment followed by probiotic treatment normalizes the microbiome.\n\nA standard evaluation for infertility includes a uterine cavity evaluation, evaluation for ovarian reserve testing, and for patients with recurrent pregnancy loss parental testing for uterine infection, chromosome analysis, autoimmune and thyroid screening. This standard workup, however, does not include a molecular or microbial assessment of the endometrium. Endometrial factors may contribute to unexplained infertility or recurrent pregnancy loss however the extent of this is unknown.\n\nWe are recruiting patients who have recurrent pregnancy loss, unexplained infertility, and healthy control patients who have had a term delivery in order to compare differences between these groups.\n\nSubjects will undergo an endometrial biopsy that will specifically test the receptivity of your endometrium as well as identify the bacterial composition of the uterine environment (microbiome). The endometrial receptivity array and microbiome testing will be performed at no cost. The endometrial receptivity array provides information on the receptivity of a patient's endometrium to the implantation of an embryo. This may yield additional information regarding the etiology of a patient's infertility and/or recurrent pregnancy loss. If this testing is abnormal we may repeat the biopsy after vaginal progesterone supplementation to see if this normalizes the results. If the microbiome is abnormal we may repeat the biopsy after oral antibiotics and vaginal probiotics to see if this normalizes your microbiome results."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion/Exclusion Criteria:\n\n1. Recurrent Pregnancy Loss\n\n Inclusion:\n * Age 18-45\n * 3 or more SABs including biochemical pregnancies OR 2 or more SABs if one is documented to be euploid\n\n Exclusion:\n * irregular menstrual cycles\n * Submucosal fibroid \\>3cm\n * Stage 3-4 endometriosis\n * BMI \\>40\n * IUD within the last 3 months\n2. Unexplained infertility Patients\n\n Inclusion:\n * TTC x \\>= 1 year\n * At least one SA with TMS \\>10 mil within last 2 years\n * At least one patent fallopian tube documented by HSG or SHG\n * Cycle length 25-35 days\n\n Exclusion:\n * Irregular menstrual cycles\n * Submucosal fibroid \\>3cm\n * Stage 3-4 endometriosis\n * BMI \\>40\n * IUD within the last 3 months\n * Less then 2 SABs including biochemical pregnancies\n3. Healthy control patients\n\nInclusion:\n\n* Patients who present for fertility preservation, sex selection, same sex couples needing fertility care, preconception counseling\n* 1 or more live births\n\nExclusion:\n\n* Irregular menstrual cycles\n* Submucosal fibroid \\>3cm\n* Stage 3-4 endometriosis\n* BMI \\>40\n* IUD within the last 3 months\n* Less then 2 SABs including biochemical pregnancies\n* No history of RPL or infertility'}, 'identificationModule': {'nctId': 'NCT03401918', 'briefTitle': 'Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility', 'orgStudyIdInfo': {'id': '40761'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with recurrent pregnancy loss or unexplained infertility', 'description': 'Patients with recurrent pregnancy loss or unexplained infertility will have an assessment of the uterine environment at the time of implantation, followed by testing of uterine endometrial gene expression using the ERA test and the uterine micro biome.\n\nThose who have abnormal results (an abnormal microbiome or an abnormal ERA) will have the option to undergo treatment followed by retesting of the uterine environment. For an abnormal ERA suggesting a pre-receptive result, luteal phase vaginal progesterone supplementation will be offered prior to re-testing of the ERA. For an abnormal microbiome a combination of oral antibiotics and vaginal probiotics will be offered prior to re-testing the uterine microbiome.', 'interventionNames': ['Diagnostic Test: Uterine ERA and microbiome testing', 'Drug: Oral antibiotics and vaginal probiotics']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Control Patients', 'description': 'Patients who have had a normal delivery and no history of infertility or recurrent pregnancy loss will have assessment of the uterine environment at the time of implantation.', 'interventionNames': ['Diagnostic Test: Uterine ERA and microbiome testing']}], 'interventions': [{'name': 'Uterine ERA and microbiome testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Uterine fluid and endometrial biopsy collection to test uterine endometrial receptivity array and microbiome.', 'armGroupLabels': ['Healthy Control Patients', 'Patients with recurrent pregnancy loss or unexplained infertility']}, {'name': 'Oral antibiotics and vaginal probiotics', 'type': 'DRUG', 'description': 'For subjects with abnormal microbiome results, oral antibiotics and vaginal probiotic treatment will be offered followed by a repeat uterine microbiome biopsy.', 'armGroupLabels': ['Patients with recurrent pregnancy loss or unexplained infertility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94087', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': 'Reproductive Endocrinology and Infertility Center at Stanford University', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ruth Bunker Lathi', 'investigatorAffiliation': 'Stanford University'}}}}