Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-23 @ 1:12 AM
Study NCT ID:
NCT02696694
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Mid-luteal Serum Progesterone Levels in Egg Donation Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-28', 'studyFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2016-02-25', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mid-luteal serum progesterone level', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'endometrial volume', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '29040638', 'type': 'DERIVED', 'citation': 'Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the impact of serum progesterone concentrations on the day of embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary outcomes, the investigators will investigate if endometrial volume measured by three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone levels and with chances of pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infertile patients undergoing their first or second egg donation cycle', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\<50 yo\n* BMI \\< 30Kg/m2\n* Hormonal replacement cycle\n* Endometrial thickness \\>6.5 mm during proliferative phase\n* Transfer of one or two blastocyst grade A-B according to ASEBIR\n\nExclusion Criteria:\n\n* Uterine pathology\n* Cryptozoospermia\n* Severe implantation failure (\\>6 GQ embryos transferred without success)'}, 'identificationModule': {'nctId': 'NCT02696694', 'briefTitle': 'Predictive Value of Mid-luteal Serum Progesterone Levels in Egg Donation Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Impact of Serum Progesterone Levels on the Day of Embryo Transfer on the Success Rate in Egg Donation Cycles Under Hormonal Replacement', 'orgStudyIdInfo': {'id': '1511-VLC-061-EL'}, 'secondaryIdInfos': [{'id': 'IVI-EST-2015-01', 'type': 'OTHER', 'domain': 'CAEPO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'P25-P75', 'description': 'serum progesterone between 25 and 75 percentile', 'interventionNames': ['Other: Progesterone 25-75']}, {'label': '<P25 ó >P75', 'description': 'serum progesterone \\<25 or \\>75 percentile', 'interventionNames': ['Other: Progesterone <25, >75']}], 'interventions': [{'name': 'Progesterone 25-75', 'type': 'OTHER', 'description': 'Impact of serum progesterone concentrations \\[25-75\\] on the day of embryo transfer in egg donation cycles under hormonal replacement therapy', 'armGroupLabels': ['P25-P75']}, {'name': 'Progesterone <25, >75', 'type': 'OTHER', 'description': 'Impact of serum progesterone concentrations (\\<25, \\>75) on the day of embryo transfer in egg donation cycles under hormonal replacement therapy', 'armGroupLabels': ['<P25 ó >P75']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'IVI Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Elena Labarta, MD, PhD', 'investigatorFullName': 'Elena Labarta', 'investigatorAffiliation': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}}}}