Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT04545918
Status:
UNKNOWN
Last Update Posted:
2021-05-07
First Post:
2020-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Convolutional Neural Network in Ovarian Follicle Identification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2020-09-04', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median size (mm) of ovarian follicles in CCAI compared to SonoAVC', 'timeFrame': '1 month', 'description': "Comparison of the mean size in mm of Cycle Clarity's Artificial Intelligence software (CCAI) compared with GE SonoAVC"}], 'secondaryOutcomes': [{'measure': 'Number of ovarian follicles in CCAI compared to Sono', 'timeFrame': '1 month', 'description': "Comparison of the number of ovarian follicles with Cycle Clarity's Artificial Intelligence software (CCAI) compared with GE SonoAVC"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Infertility', 'Ovarian Follicle'], 'conditions': ['Infertility, Female', 'Ovarian Follicular Cyst']}, 'referencesModule': {'references': [{'pmid': '27126581', 'type': 'BACKGROUND', 'citation': 'Al-Inany HG, Youssef MA, Ayeleke RO, Brown J, Lam WS, Broekmans FJ. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2016 Apr 29;4(4):CD001750. doi: 10.1002/14651858.CD001750.pub4.'}, {'pmid': '2058957', 'type': 'BACKGROUND', 'citation': 'Gordon K, Hodgen GD. GnRH analogues in ovarian stimulation. Ann N Y Acad Sci. 1991;626:238-49. doi: 10.1111/j.1749-6632.1991.tb37919.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'A prospective cohort trial studying patients with infertility undergoing an ovarian stimulation with exogenous gonadotropins. Ovarian monitoring will be performed with a combination of transvaginal ultrasound and 2 dimensional human measurements of the follicle development on the right and left ovaries along with SonoAVC. Human and SonoAVC measurements will then be compared to mask region-based convolutional neural network in follicle identification and measurement during during the ovarian stimulation.', 'detailedDescription': 'This is a prospective cohort trial in which a total of 80 female subjects with infertility between the ages of 21 and 42 years of age undergoing ovarian stimulation will be recruited. After giving informed written consent the subject to undergo standard ovarian ultrasound monitoring with transvaginal ultrasounds during the ovarian stimulation. Monitoring will be performed with two-dimensional measurements of each follicle greater than 10 mm in size by the ultrasonographer. SonoAVC will then be applied to both ovaries for automated counting and measurement of the follicles within the ovaries. The patient will then undergo two 6-second ultrasounds of the right and left ovaries which will then be transmitted in a DICOM format to mask regional based recurrent neural network which is been trained and validated for follicle detection and quantification using curated transvaginal ultrasound images.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eighty (80) consecutive female subjects of any race, 21 - 42 years of age meeting the inclusion criteria will be enrolled in the study conducted at one of 4 Coastal Fertility Specialists fertility clinics located in South Carolina and Georgia, USA.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile women ages 21-42 years old undergoing ovarian hyperstimulation as part of the treatment care.\n\nWomen with at least one ovary visible with transvaginal ultrasound. Women with at least one follicle 10 mm or greater in average diameter.\n\nExclusion Criteria:\n\n* Women less than 21 years of age or greater than 42 years of age. Women without a visible ovary by transvaginal ultrasound. Women without a follicle at least 10 mm in average diameter'}, 'identificationModule': {'nctId': 'NCT04545918', 'briefTitle': 'Convolutional Neural Network in Ovarian Follicle Identification', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cycle Clarity'}, 'officialTitle': 'Assessing a Mask Region-based Convolutional Neural Network in Follicle Identification and Measurement During Ovarian Stimulation', 'orgStudyIdInfo': {'id': 'CC2020-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infertile Female', 'description': '90 female patients with infertility undergoing an ovarian stimulation with use of exogenous gonadotropins.', 'interventionNames': ['Device: Follicle Clarity']}], 'interventions': [{'name': 'Follicle Clarity', 'type': 'DEVICE', 'description': 'Mask Region-based Convolutional Neural Network in Ultrasound Follicle Identification', 'armGroupLabels': ['Infertile Female']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael J Slowey', 'role': 'CONTACT', 'email': 'michael.slowey@coastalfertility.us', 'phone': '843-883-5800'}, {'name': 'Heather Cook, MD', 'role': 'CONTACT', 'email': 'heather.cook@coastalfertility.us', 'phone': '8438835800'}, {'name': 'Michael J Slowey, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Heather M Cook, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jessica McLaughlin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Coastal Fertility Specialists', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}], 'centralContacts': [{'name': 'John A Schnorr, MD', 'role': 'CONTACT', 'email': 'john.schnorr@cycleclarity.com', 'phone': '843-883-6200'}, {'name': 'Susan R. Schnorr', 'role': 'CONTACT', 'email': 'susan.schnorr@cycleclarity.com', 'phone': '843-883-6200'}], 'overallOfficials': [{'name': 'John A. Schnorr, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cycle Clarity, Founder'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cycle Clarity', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}