Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-01-27 @ 5:30 AM
Study NCT ID:
NCT06526520
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2024-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood tests for hormonal assessment'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relaxin measurement', 'timeFrame': '4 to 6 months', 'description': 'Measurement of Relaxin in the different types of frozen embryo transfer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['frozen embryo transfer', 'hormonal replacement cycle', 'natural cycle', 'Relaxin'], 'conditions': ['Frozen Embryo Transfer']}, 'descriptionModule': {'briefSummary': 'To investigate the levels of Relaxin in different types of endometrial preparation for a frozen embryo transfer cycle. Up to now it is unclear, whether ovulation with a functional corpus luteum (CL) will be present in a natural proliferative phase (NPP) endometrial preparation approach.', 'detailedDescription': 'The last years have seen a distinct shift from fresh (fresh ET) to frozen embryo transfer (FET) cycles. Furthermore it became obvious, that the endometrial preparation approach has a significant impact on the course of the pregnancy and that a HRT endometrial preparation approach is associated with a higher risk for bleeding and miscarriages in early pregnancy and for the development of pregnancy induced hypertension and pre-eclampsia later in pregnancy.\n\nThese conditions are attributed to the absence of a CL in the HRT approach. Lately a new endometrial preparation approach is discussed and performed, the so called natural proliferative phase protocol, in which the follicle growth is monitored and when the lining is deemed to have a sufficient thickness and the triple lining pattern, exogeneous progesterone is started to induce secretory transformation before spontaneous ovulation. Despite some studies showing, that exogeneous progesterone administration might induce ovulation, it is not clear whether there will be a CL, producing Relaxin, in the NPP approach.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- healthy volunteers with regular cycles', 'genderDescription': 'regular menstrual cycles', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regular menstrual cycles\n\nExclusion Criteria:\n\n* abnormal findings of the ovaries (e.g endometriosis)\n* Intake of any hormones within 3 months of study start\n* desire to become pregnant'}, 'identificationModule': {'nctId': 'NCT06526520', 'briefTitle': 'Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'ART Fertility Clinics LLC'}, 'officialTitle': 'Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer', 'orgStudyIdInfo': {'id': '2406-ABU-007-BL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Natural cycle', 'description': 'Monitoring of a natural cycle'}, {'label': 'natural proliferative phase cycle', 'description': 'Monitoring of a natural proliferative phase cycle', 'interventionNames': ['Drug: Exposure to progesterone or HRT medication']}, {'label': 'Hormonal replacement cycle', 'description': 'Monitoring of a hormonal replacement cycle', 'interventionNames': ['Drug: Exposure to progesterone or HRT medication']}], 'interventions': [{'name': 'Exposure to progesterone or HRT medication', 'type': 'DRUG', 'description': 'to add either progesterone only in the NPP protocol or E2 and progesterone in a HRT protocol', 'armGroupLabels': ['Hormonal replacement cycle', 'natural proliferative phase cycle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60202', 'city': 'Abu Dhabi', 'state': 'Abu Dhabi Emirate', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Barbara Lawrenz', 'role': 'CONTACT', 'email': 'barbara.lawrenz@artfertilityclinics.com', 'phone': '00971526500757'}, {'name': 'Jonalyn Edades, MBA', 'role': 'CONTACT', 'email': 'barbara.lawrenz@web.de', 'phoneExt': 'Lawrenz'}, {'name': 'Barbara Lawrenz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ART Fertiltiy Clinic', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Barbara Lawrenz, M.D. PhD', 'role': 'CONTACT', 'email': 'barbara.lawrenz@artfertilityclinics.com', 'phone': '800 337845489'}, {'name': 'Jonalyn Edades, MBA', 'role': 'CONTACT', 'email': 'jonalyn.edades@artfertilityclinics.com', 'phone': '800 337845489'}], 'overallOfficials': [{'name': 'Barbara Lawrenz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ART Fertility Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ART Fertility Clinics LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}