Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-31 @ 4:03 PM
Study NCT ID:
NCT05634850
Status:
UNKNOWN
Last Update Posted:
2022-12-02
First Post:
2022-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-06-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2022-11-22', 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the usability of Kinder by patients undergoing controlled ovarian stimulation cycle', 'timeFrame': 'A single controlled ovarian stimulation cycle, typically up to 20 days', 'description': 'Patients will perform tests with the Kinder system and complete a usability questionnaire on their experience.'}, {'measure': 'Correlation of fertility hormone serum and urinary metabolites', 'timeFrame': 'A single controlled ovarian stimulation cycle, typically up to 20 days', 'description': 'Correlation of E2, P4 and LH and their urinary metabolites (E1-3G, PdG and LH)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fertility Disorders']}, 'descriptionModule': {'briefSummary': "In-vitro fertilisation (IVF) treatment involves women undergoing hormone stimulation (drug dosing) to produce more oocytes (eggs) to increase their chances of fertilisation. The information that IVF clinicians currently collect on a woman's hormonal response to IVF drug dosing comes from in-clinic blood testing. This requires patients to make a visit to the IVF clinic every few days to have the blood samples taken. The blood is then analysed in a laboratory for the hormone levels and the results are then sent back to the clinic. This monitoring process of frequent onsite visits and blood draws can often be quite inconvenient and disruptive for patients.\n\nThis observational study will assess a non-invasive in vitro diagnostic (IVD) device for measuring the common fertility hormones in urine. The test system is for use by both healthcare professionals in a clinical setting and nonprofessionals in a home care setting under the guidance of a health care professional. This study will provide pilot data on the usability of the IVD device from the intended end users as well as the correlation of urinary metabolite levels as measured by the IVD device and the serum concentration as measured by blood analysers."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '30 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 30-40 years older undergoing a controlled ovarian stimulation cycle as part of assisted reproductive treatment.', 'genderDescription': 'Female only as device test female fertility hormones', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing controlled ovarian stimulation treatment\n* 30 to 40 years old (inclusive)\n* Willingness to comply with study procedures for collection and testing of urine\n\nExclusion Criteria:\n\n* Illiterate in English\n* No access to smart phone that is compatible with App and/or is not connected to the internet\n* Patients who are diabetic (Type I and Type II), have insulin resistance or a renal/liver disorder\n* Patients who have taken oral contraceptives up to 4 days before the first stimulation day of the cycle'}, 'identificationModule': {'nctId': 'NCT05634850', 'briefTitle': 'Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Planet Innovation'}, 'officialTitle': 'A Pilot Study: A Prospective, Longitudinal, Observational Study, Evaluating the Usability of the Product Kinder System Trial, Home Based Hormone for In-Vitro Fertilization (IVF) Monitoring System.', 'orgStudyIdInfo': {'id': '470_1036'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Kinder', 'type': 'DEVICE', 'description': 'Participants will test at their urine with at home with in the device. Results are sent via an app back to the clinic for reporting.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Serene Lai', 'role': 'CONTACT', 'email': 'xinhui@nus.edu.sg', 'phone': '+65 6772 2681'}, {'name': 'Peng Cheang Wong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Planet Innovation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}