Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:51 AM
Study NCT ID:
NCT07449494
Status:
COMPLETED
Last Update Posted:
2026-03-04
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Live Birth Rate After First Embryo Transfer With or Without Glucocorticoid Sensitivity Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'ACTUAL', 'count': 148}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live Birth Rate After First Embryo Transfer', 'timeFrame': 'From first embryo transfer to delivery (up to approximately 9 months)', 'description': 'Live birth defined as delivery of a viable infant beyond 24 weeks of gestation, assessed after the first fresh or frozen blastocyst transfer performed following immune evaluation.'}], 'secondaryOutcomes': [{'measure': 'Clinical Pregnancy Rate', 'timeFrame': 'Time Frame: 6-8 weeks after embryo transfer', 'description': 'Clinical pregnancy confirmed by ultrasound visualization of a gestational sac.'}, {'measure': 'Implantation Rate', 'timeFrame': ': 6-8 weeks after embryo transfer', 'description': 'Number of gestational sacs per number of embryos transferred.'}, {'measure': 'Ongoing Pregnancy Rate', 'timeFrame': '10 weeks after embryo transfer', 'description': 'Ongoing pregnancy confirmed by ultrasound visualization of a gestational sac with fetal cardiac activity.'}, {'measure': 'Miscarriage Rate per Clinical Pregnancy', 'timeFrame': 'Up to 24 weeks of gestation', 'description': 'Pregnancy loss before 24 weeks of gestation among clinical pregnancies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glucocorticoids', 'IVF', 'Embryo transfer', 'Live birth rate', 'sensitivity testing', 'uterine immune over-activation'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '40066441', 'type': 'BACKGROUND', 'citation': 'Ledee N, Petitbarat M, Dray G, Chevrier L, Kazhalawi A, Rahmati M, Vicaut E, Diallo A, Cassuto NG, Ruoso L, Prat-Ellenberg L. Endometrial immune profiling and precision therapy increase live birth rate after embryo transfer: a randomised controlled trial. Front Immunol. 2025 Feb 24;16:1523871. doi: 10.3389/fimmu.2025.1523871. eCollection 2025.'}, {'pmid': '29627619', 'type': 'BACKGROUND', 'citation': 'Ledee N, Prat-Ellenberg L, Petitbarat M, Chevrier L, Simon C, Irani EE, Vitoux D, Bensussan A, Chaouat G. Impact of prednisone in patients with repeated embryo implantation failures: Beneficial or deleterious? J Reprod Immunol. 2018 Jun;127:11-15. doi: 10.1016/j.jri.2018.03.003. Epub 2018 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective single-center observational cohort study evaluates live birth rates after the first embryo transfer following immune assessment in infertile women with documented uterine immune overactivation.\n\nIn routine clinical practice, glucocorticoids represent first-line therapy for immune overactivation. Some patients underwent glucocorticoid sensitivity testing prior to embryo transfer based solely on standard clinical practice and patient preference. In cases of demonstrated glucocorticoid resistance, alternative therapeutic strategies were implemented according to usual care.\n\nThe study analyzes clinical data collected between September 2020 and November 2025 to assess the association between prior glucocorticoid sensitivity testing and live birth rate after the first fresh or frozen blastocyst transfer performed following immune evaluation.\n\nNo treatment allocation was determined by a study protocol.', 'detailedDescription': 'This retrospective single-center cohort study was conducted at Hôpital Pierre Rouquès - Les Bluets (Paris, France) and includes infertile women aged 40 years or younger undergoing in vitro fertilization (IVF) between September 2020 and November 2025.\n\nAll included patients had documented uterine immune overactivation identified through routine immune assessment prior to embryo transfer. In standard clinical practice at our center, glucocorticoids represent first-line therapy for immune overactivation.\n\nSome patients underwent glucocorticoid sensitivity testing prior to embryo transfer, based solely on routine clinical practice and patient preference. In cases of demonstrated glucocorticoid resistance, alternative therapeutic strategies were implemented according to standard care.\n\nThe study compares live birth rates following the first fresh or frozen blastocyst transfer performed after immune evaluation in patients managed with or without prior glucocorticoid sensitivity testing.\n\nThis study is purely observational and retrospective. No treatment allocation or testing decision was determined by a study protocol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of infertile women aged 40 years or younger undergoing in vitro fertilization (IVF) with a planned fresh or frozen blastocyst transfer at Hôpital Pierre Rouquès - Les Bluets (Paris, France). All patients had documented uterine immune overactivation identified through routine immune assessment prior to embryo transfer. Patients were managed according to standard clinical practice, with first-line glucocorticoid therapy, with or without prior glucocorticoid sensitivity testing.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile patients undergoing IVF with planned fresh or frozen embryo transfer\n* Age ≤ 40 years at the time of the transfer\n* Documented uterine immune over-activation\n* Treatment with glucocorticoids in routine clinical practice, with or without prior glucocorticoid sensitivity testing\n* Fresh or frozen blastocyst transfer performed within 9 months following immune assessment at Hôpital des Bluets\n\nExclusion Criteria:\n\n* • Age \\> 40 years\n\n * No available uterine immune profile\n * Normal immune profile or immune underactivation\n * Management exclusively with alternative therapeutic strategies (e.g., low molecular weight heparin \\[LMWH\\], intralipid therapy) or combination therapies (e.g., LMWH + glucocorticoids or intralipid + glucocorticoids)\n * Embryo transfer performed more than 9 months after immune assessment\n * Cleavage-stage embryo transfer\n * Embryo transfer performed in another center\n * Oocyte donation IVF cycles'}, 'identificationModule': {'nctId': 'NCT07449494', 'acronym': 'GLUCO-IVF', 'briefTitle': 'Live Birth Rate After First Embryo Transfer With or Without Glucocorticoid Sensitivity Testing', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Pierre Rouques - Les Bluets'}, 'officialTitle': 'Comparison of Live Birth Rates in Patients With Immune Overactivation Receiving Glucocorticoids With or Without Prior Sensitivity Testing: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'PRS-BLUETS-2020-GLUCO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Sensitivity Testing', 'description': 'Patients with documented uterine immune overactivation managed with first-line glucocorticoid therapy in routine clinical practice without prior glucocorticoid sensitivity testing.'}, {'label': 'Sensitivity Testing', 'description': 'Patients with documented uterine immune overactivation who underwent glucocorticoid sensitivity testing prior to embryo transfer. In cases of glucocorticoid resistance, alternative therapeutic strategies were implemented according to routine clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pierre Rouquès - Les Bluets', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Pierre Rouques - Les Bluets', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}