Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-01-24 @ 11:12 PM
Study NCT ID:
NCT02189369
Status:
UNKNOWN
Last Update Posted:
2017-03-07
First Post:
2014-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-06', 'studyFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endometrial receptivity', 'timeFrame': '24 hours before embryo transfer', 'description': 'The endometrial samples will be extracted 24 hours before the embryo transfer in order to analyze the quantity of prostaglandins.'}], 'secondaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '15 days', 'description': 'We will reffer a correlation between the prostaglandin results and the implantation rate.'}, {'measure': 'Pregnancy rate', 'timeFrame': '15 days', 'description': 'We will reffer a correlation between the prostaglandin results and the implantation rate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'This clinical validation study is being carried out to validate the efficacy of a test measuring the clinical application of prostaglandins present in the endometrial fluid in patients, 24 hours before the embryonic transfer. This test is capable of predicting endometrial receptivity without the need of performing a biopsy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any IVF patient being treated for single or double embryo transfer\n* BMI: 20 - 30\n* Normal ovarian response (7 - 8 ovocitos) in IVF treatment with AFC ≥ 8, (AFC = Antral Follicle Count)\n* Elective embryo transfer\n* Normal uterine cavity\n* Age: ≤ 38 years old for patients with own oocytes; ≤ 50 years old for patients with donated oocytes.\n\nExclusion Criteria:\n\n* Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)\n* Patients with severe male factor ( ≥ 2\\*106 espermatozoides/ml).'}, 'identificationModule': {'nctId': 'NCT02189369', 'briefTitle': 'Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Igenomix'}, 'officialTitle': 'Clinical Validation of a Diagnostic Test Which Measures the Endometrial Prostaglandins Liquid 24 Hours Before Embryo Transfer and That is Capable of Predicting a State of Endometrial Receptivity', 'orgStudyIdInfo': {'id': '1311-FIVI-135-CS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Day 3 embryo-Own-above cutoff', 'description': 'Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates', 'interventionNames': ['Other: Day 3 embryo transfer']}, {'type': 'EXPERIMENTAL', 'label': 'Day 5 embryo-Own-above cutoff', 'description': 'Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates', 'interventionNames': ['Other: Day 5 embryo transfer']}, {'type': 'EXPERIMENTAL', 'label': 'Day 3 embryo-Donor-above cutoff', 'description': 'Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates', 'interventionNames': ['Other: Day 3 embryo transfer']}, {'type': 'EXPERIMENTAL', 'label': 'Day 5 embryo-Donor- above cutoff', 'description': 'Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates', 'interventionNames': ['Other: Day 5 embryo transfer']}, {'type': 'EXPERIMENTAL', 'label': 'Day 3 embryo-Donor-lower cutoff', 'description': 'Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates', 'interventionNames': ['Other: Day 3 embryo transfer']}, {'type': 'EXPERIMENTAL', 'label': 'Day 5 embryo-Donor-lower cutoff', 'description': 'Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates', 'interventionNames': ['Other: Day 5 embryo transfer']}, {'type': 'EXPERIMENTAL', 'label': 'Day 3 embryo-own-lower cutoff', 'description': 'Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates', 'interventionNames': ['Other: Day 3 embryo transfer']}, {'type': 'EXPERIMENTAL', 'label': 'Day 5 embryo-own-lower cutoff', 'description': 'Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates', 'interventionNames': ['Other: Day 5 embryo transfer']}], 'interventions': [{'name': 'Day 3 embryo transfer', 'type': 'OTHER', 'description': 'Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer', 'armGroupLabels': ['Day 3 embryo-Donor-above cutoff', 'Day 3 embryo-Donor-lower cutoff', 'Day 3 embryo-Own-above cutoff', 'Day 3 embryo-own-lower cutoff']}, {'name': 'Day 5 embryo transfer', 'type': 'OTHER', 'description': 'Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer', 'armGroupLabels': ['Day 5 embryo-Donor- above cutoff', 'Day 5 embryo-Donor-lower cutoff', 'Day 5 embryo-Own-above cutoff', 'Day 5 embryo-own-lower cutoff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carlos Gómez, Ma', 'role': 'CONTACT', 'email': 'carlos.gomez@igenomix.com', 'phone': '+34670506469'}, {'name': 'Carlos Simón, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Felip Vilella, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fundación IVI', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carlos Gómez, MA', 'role': 'CONTACT', 'email': 'carlos.gomez@igenomix.com'}, {'name': 'Carlos Simón, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marcos Meseguer, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sergio Cabanillas, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IVI Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Carlos Gómez, MA', 'role': 'CONTACT', 'email': 'carlos.gomez@igenomix.com', 'phone': '+34670506469'}], 'overallOfficials': [{'name': 'Carlos Simon, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundación IVI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Igenomix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Carlos Simón', 'investigatorFullName': 'Carlos Simon', 'investigatorAffiliation': 'Igenomix'}}}}