Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-02 @ 8:14 AM
Study NCT ID:
NCT05220995
Status:
UNKNOWN
Last Update Posted:
2022-02-02
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Miminal Stimulation Protocol on Preimplantation Genetic Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'embryo'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'euploid rates', 'timeFrame': '3 months', 'description': 'the effects of different stimulation protocols on euploid rates'}], 'secondaryOutcomes': [{'measure': 'pregnancy rates', 'timeFrame': '3 months', 'description': 'the effects of different stimulation protocols on pregnancy rates'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preimplantation genetic screening', 'gonadotropin dosage', 'euploidy rates'], 'conditions': ['Preimplantation Genetic Screening']}, 'descriptionModule': {'briefSummary': 'PGS has been the most effective method for embryo selection in IVF cycles. Euploidy rates decrease significantly with advancing maternal age (AMA). The dosage of gonadotropins also may be increased to recruit an adequate number of follicles in AMA women, minimal Stimulation Protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) for controlled ovarian hyperstimulation is defined for poor ovarian response women. The aim of this study is to show minimal stimulation protocol affect euploidy and pregnancy rates in preimplatation genetic screening (PGS) cycles with single embryo transfer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '38 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '200 advanced maternal aged women', 'genderDescription': 'more than 38 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Advanced maternal aged -\n\nExclusion Criteria: Severe male factor, endometriosis, and absolute tubal factor were excluded in this study.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05220995', 'briefTitle': 'The Effects of Miminal Stimulation Protocol on Preimplantation Genetic Screening', 'organization': {'class': 'OTHER', 'fullName': 'Nigde Omer Halisdemir University'}, 'officialTitle': 'The Effects of Miminal Stimulation Protocol on Clinical Outcomes of Advanced Maternal Aged Women With Preimplantation Genetic Screening', 'orgStudyIdInfo': {'id': '31.01.2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': '100 patients with minimal', 'description': 'In advancing maternal age (AMA) women, minimal stimulation protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women.', 'interventionNames': ['Genetic: protocol']}, {'label': '100 patients with recombinant FSH antagonist protocol', 'description': 'In advancing maternal age (AMA) women, flexible antagonist protocol with recombinant FSH were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women.', 'interventionNames': ['Genetic: protocol']}], 'interventions': [{'name': 'protocol', 'type': 'GENETIC', 'description': 'ovarian stimulation protocols on euploid rates were compared.', 'armGroupLabels': ['100 patients with minimal', '100 patients with recombinant FSH antagonist protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'state': 'Gevher Nesibe', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gokalp Oner', 'role': 'CONTACT', 'email': 'onerg@yahoo.com', 'phone': '905339268238'}], 'facility': 'Gokalp Oner', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'zip': '38039', 'city': 'Kayseri', 'state': 'Gevher Nesibe', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gokalp Oner', 'role': 'CONTACT', 'email': 'onerg@yahoo.com', 'phone': '0905062346822'}], 'facility': 'Gokalp Oner', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We can not share.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gokalp Oner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Adem Yavuz', 'investigatorFullName': 'Gokalp Oner', 'investigatorAffiliation': 'Nigde Omer Halisdemir University'}}}}