Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-25 @ 4:13 AM
Study NCT ID:
NCT03725904
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2018-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daytime Profile of Salivary Progesterone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-18', 'studyFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of free progesterone in saliva', 'timeFrame': '12 hours'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '8 weeks', 'description': 'Ultrasound detected gestational sack divided with number of embryo transfer'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '12 weeks', 'description': 'Viable pregnancy after gestational week 12+0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Progesterone', 'Saliva', 'IVF', 'Frozen embryo transfer'], 'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. If progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future ART patients with insufficient progesterone levels who might benefit from additional exogenous progesterone supplementation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years\n* One or two good quality embryos for transfer on day 5.\n* BMI \\>18,5 \\<30 kg/m²\n\nExclusion Criteria:\n\n* No good quality embryos for transfer\n* Uterine abnormalities\n* One ovary\n* Oocyte donation'}, 'identificationModule': {'nctId': 'NCT03725904', 'briefTitle': 'Daytime Profile of Salivary Progesterone', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Viborg, Skive'}, 'officialTitle': 'Daytime Profile of Salivary Progesterone During the Mid-luteal Phase of IVF and FET Cycles', 'orgStudyIdInfo': {'id': 'Saliva1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVF/FET', 'interventionNames': ['Diagnostic Test: Progesterone analysis in saliva']}], 'interventions': [{'name': 'Progesterone analysis in saliva', 'type': 'DIAGNOSTIC_TEST', 'description': 'Analysis of salava progesterone', 'armGroupLabels': ['IVF/FET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7800', 'city': 'Skive', 'country': 'Denmark', 'facility': 'Fertility Clinic Regional Hospital Skive', 'geoPoint': {'lat': 56.56699, 'lon': 9.02707}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Humaidan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston IVF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Peter Humaidan', 'investigatorAffiliation': 'Regionshospitalet Viborg, Skive'}}}}