Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-28 @ 2:49 AM
Study NCT ID:
NCT05876234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Predictive Value of Progesterone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2023-05-08', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy rate', 'timeFrame': '11 to 13 weeks after last menstruation', 'description': 'Fetal heart beat at ultrasound'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '6 to 8 weeks after last menstruation', 'description': 'Ultrasound visualisation of the gestational sac'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['progesterone', 'embryo transfer'], 'conditions': ['Subfertility']}, 'descriptionModule': {'briefSummary': 'To evaluate a 5 ng/ml serum progesterone (P4) threshold policy for the addition of subcutaneous (SC) P4 in artificially prepared frozen embryo transfer cycles treated with vaginal P4. We assess whether the addition of SC P4 rescues cycles with serum P4 \\<5 ng/ml and we study the impact of not supplementing cycles with serum P4 \\>5 ng/ml by comparing them with serum P4 cycles above the conventionally proposed cut-off of 10 ng/ml.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '47 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Treated at Ghent University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': '* Embryo transfer between March 1st 2021 and March 31st 2023\n* Determination of progesterone on the day of embryo transfer'}, 'identificationModule': {'nctId': 'NCT05876234', 'acronym': 'PFRET', 'briefTitle': 'The Predictive Value of Progesterone', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'The Predictive Value of the Progesterone Level on the Day of Embryo Transfer in Cryo Cycles', 'orgStudyIdInfo': {'id': 'ONZ-2023-0223'}}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital - Department of Reproductive Medicine', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Dominic Stoop, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}