Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT05493202
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Superovulation And Urinary Concentration of Estrone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of E3G with oocyte retrieval parameters', 'timeFrame': 'Approximately 2 weeks per patient to complete data collection', 'description': 'Regression of E3G levels to total and mature number of oocytes retrieved'}, {'measure': 'Correlation of E3G and E2 levels throughout stimulation', 'timeFrame': 'Approximately 2 weeks per patient to complete data collection', 'description': 'Comparison of urine and serum hormone levels'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['in vitro fertilization', 'IVF', 'hormone testing'], 'conditions': ['in Vitro Fertilization', 'Hormone Testing']}, 'referencesModule': {'references': [{'pmid': '36959966', 'type': 'DERIVED', 'citation': 'Nakhuda GS, Li N, Yang Z, Kang S. At-home urine estrone-3-glucuronide quantification predicts oocyte retrieval outcomes comparably with serum estradiol. F S Rep. 2023 Jan 28;4(1):43-48. doi: 10.1016/j.xfre.2023.01.006. eCollection 2023 Mar.'}]}, 'descriptionModule': {'briefSummary': 'To determine if measurement of urinary estrone glucuronide concentrations with an at-home device is correlated with superovulatory response during gonadotropin stimulated IVF cycles.', 'detailedDescription': 'Hypothesis\n\nUrinary estradiol concentrations measured with an at-home device correlates with gonadotropin response during superovulation for IVF and can serve as an alternative to serum estradiol measurements.\n\nJustification\n\nThe in vitro fertilization (IVF) process entails gonadotropin stimulation to obtain supernumerary oocytes. To ensure an adequate and safe administration, gonadotropin treatment requires monitoring with transvaginal sonography (TVS) to determine the quantity and size of ovarian follicles. In addition, serum estradiol (E2) concentration reflects bioactivity of the follicles and is used to modulate dosing. TVS and E2 are complementary modalities used synchronously to dynamically optimize the gonadotropin protocol. For the typical IVF stimulation cycle with an GnRH antagonist protocol, the patient will require 10-12 days of gonadotropin administration, during which time the 3-6 visits for TVS and blood tests will be needed.\n\nReducing the invasiveness of procedures can improve the patient experience. Repetitive phlebotomy, as is required for serum estradiol measurements during IVF, can be unpleasant and painful. Thus, a less invasive alternative with at-home urinary testing may be more desirable and convenient.\n\nEstrone glucuronide (E3G) is a metabolite of E2 that can be measured in the urine. Urinary E3G with an FDA and CE registered home device called the Mira Fertility Tracker ("Mira"). Correlation between the serum hormones and their respective urinary metabolites has been established but the efficacy of monitoring urinary E3G has not been demonstrated in the context of IVF.\n\nThe purpose of the current observational study is to compare urinary E3G with traditional serum E2 monitoring during gonadotropin stimulation for IVF and correlate the levels with stimulation outcomes. If validated, urinary hormone monitoring could serve as a more patient-friendly alternative to repetitive phlebotomy required for serum hormone measurement during IVF.\n\nResearch Design\n\nPatients will undergo IVF per clinical indication. Gonadotropin dosing will be determined at the discretion of the responsible physician using standard dosing criteria (age, ovarian reserve testing, prior history, etc). For consistency of comparison, the study population will focus on patients with a normal ovarian reserve (AMH 1-3.5ng/mL).\n\nDuring stimulation, the monitoring schedule will be consistent with routine clinical protocols. In general, the initial E2 are determined on day 6 of stimulation from a single serum sample, and subsequent serum E2 and TVS are checked from day 8 onwards, as is clinically indicated by patient response to gonadotropin stimulation.\n\nUrinary E3G will be monitored daily with first morning urine from the first day through the final day of gonadotropin stimulation. A Mira device and testing wands will be provided to each participating patient and urinary testing will be performed by the patient at home.\n\nPrimary outcomes will include correlation of E3G with the number of total and mature oocytes retrieved, and a comparison to the serum E2 correlation to the same parameters. Secondary outcomes will include correlation of urinary E3G and serum E2 levels throughout stimulation.\n\nAdditional details regarding laboratory study protocols are as follows:\n\nMeasurement of urine E3G: The Mira be used to measure urinary E3G via immunofluorescence method. First morning urine will be collected by the patient at home. A test wand will be dipped into the urine sample for ten seconds, then inserted into a palm-sized device.\n\nAll other protocols are consistent with routine clinical practice. Briefly, serum samples for E2 will be collected by venipuncture and processed using a commercially available E2 chemiluminescent assay on automated immunoanalyzer (Beckman-Coulter Access 2) in an accredited commercial laboratory (Novavita, Vancouver, BC). Sonography will be performed by licensed physicians with an endovaginal probe, consistent with standard clinical practice. IVF laboratory procedures will be performed by trained embryologists at the Olive Fertility Centre (Vancouver, BC).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from patients undergoing IVF or egg freezing at the Olive Fertility Centre.', 'genderDescription': 'Females who are undergoing gonadotropin stimulation for IVF.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAges 21-45 AMH between 1-3.5 ng/mL (7.14-24.5 pmol/L) within 1 year of enrollment Gonadotropin stimulation with GnRH antagonist protocol Able to collect 1st morning urine\n\nExclusion Criteria:\n\nAversion to phlebotomy (as is normally required during IVF). Use of aromatase inhibitors during stimulation (which can affect serum E2 levels)'}, 'identificationModule': {'nctId': 'NCT05493202', 'acronym': 'SAUCE', 'briefTitle': 'Superovulation And Urinary Concentration of Estrone', 'organization': {'class': 'OTHER', 'fullName': 'Olive Fertility Centre'}, 'officialTitle': 'Correlation of Urinary Estrone Glucuronide With Superovulatory Response in IVF Cycles.', 'orgStudyIdInfo': {'id': 'SAUCE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': '30 patients undergoing gonadotropin stimulation for IVF or egg freezing.', 'interventionNames': ['Device: Mira Fertility Tracker']}], 'interventions': [{'name': 'Mira Fertility Tracker', 'type': 'DEVICE', 'description': 'Non-interventional: observational, documenting urine E3G levels during gonadotropin stimulation.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z3X7', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Olive Fertility Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olive Fertility Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Quanovate Tech Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}