Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-28 @ 4:11 PM
Study NCT ID:
NCT02205866
Status:
COMPLETED
Last Update Posted:
2019-06-28
First Post:
2014-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Non Receptive Endometrium in Obese Women
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2014-07-25', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non Receptive Endometrium', 'timeFrame': '25 days', 'description': 'To evaluate the incidence of Not Receptive endometrium in obese infertile women compared to infertile normal weight women using an adequate sample size.'}], 'secondaryOutcomes': [{'measure': 'Distribution of fat and risk factors', 'timeFrame': '4 months', 'description': 'Carry out a subanalysis concerning the distribution of central and peripheric fat and risk factors of metabolic syndrome including: Age (years); Height (m); Weight (kg) ; BMI (kg/m2); Waist (cm) ; Hip (cm); Index waist-hip ratio (WHR) waist (cm) / hip (cm); Blood pressure; insulinemia Fasting blood glucose (mmol / L); PTG ( tolerance oral glucose ) (mmol / L), Total cholesterol and fractions; Triglycerides Microalbuminuria; bA1C, HC-reactive protein.'}, {'measure': 'Look for specific endometrial gene patterns.', 'timeFrame': '25 days', 'description': 'Find patterns of expression of specific genes in endometrial obese women: we will by analyzing the expression of 238 genes obtained after endometrial endometrial biopsy.'}, {'measure': 'Evaluate the result of assisted reproduction treatment.', 'timeFrame': '12 months', 'description': 'Relate if the displacement of the WOI induced by the obesity is clinically relevant after the personalized embryo transfer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '27919438', 'type': 'DERIVED', 'citation': 'Comstock IA, Diaz-Gimeno P, Cabanillas S, Bellver J, Sebastian-Leon P, Shah M, Schutt A, Valdes CT, Ruiz-Alonso M, Valbuena D, Simon C, Lathi RB. Does an increased body mass index affect endometrial gene expression patterns in infertile patients? A functional genomics analysis. Fertil Steril. 2017 Mar;107(3):740-748.e2. doi: 10.1016/j.fertnstert.2016.11.009. Epub 2016 Dec 2.'}]}, 'descriptionModule': {'briefSummary': "This study evaluates the incidence of Non Receptive endometrium in obese infertile women compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's Window of Implantation, regardless of the histological appearance of the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile women: \\> 1 year of regular unprotected intercourse without evidence of pregnancy.\n* Normal uterus by 2D/3D ultrasound scan and/or hysteroscopy\n* No endometriosis\n* Presence of both ovaries\n* \\< 45 years old (in ovum donation, outcome parameters are not affected until this age in all the current published studies).\n\nExclusion Criteria:\n\n* Hydrosalpinx\n* Stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy.\n* Implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy)\n* Recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)'}, 'identificationModule': {'nctId': 'NCT02205866', 'briefTitle': 'Incidence of Non Receptive Endometrium in Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.', 'orgStudyIdInfo': {'id': '1403-VLC-012-JB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Non Obese patients', 'interventionNames': ['Other: Endometrial Receptivity Array analysis of endometrial biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Obese patients', 'interventionNames': ['Other: Endometrial Receptivity Array analysis of endometrial biopsy']}], 'interventions': [{'name': 'Endometrial Receptivity Array analysis of endometrial biopsy', 'type': 'OTHER', 'description': 'A biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305-5101', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stamford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'IVI Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Jose Bellver, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Jose Bellver', 'investigatorFullName': 'Jose Bellver', 'investigatorAffiliation': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}}}}