Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT05678751
Status:
UNKNOWN
Last Update Posted:
2023-01-10
First Post:
2022-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rapid Detection Method for Microorganisms in the Lower Genital Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], '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'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-15', 'size': 355451, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-03T11:24', 'hasProtocol': True}, {'date': '2022-06-14', 'size': 146286, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-03T11:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Vaginal and cervical secretions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-23', 'studyFirstSubmitDate': '2022-12-23', 'studyFirstSubmitQcDate': '2022-12-23', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower genital tract pathogen', 'timeFrame': 'at recruitment', 'description': 'Ureaplasma urealyticum, mycoplasma hominis, chlamydia antigen, gonococcus'}, {'measure': 'Lower genital CST', 'timeFrame': 'at recruitment', 'description': 'Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'referencesModule': {'references': [{'pmid': '28209488', 'type': 'BACKGROUND', 'citation': 'Chen YJ, Hsu TF, Huang BS, Tsai HW, Chang YH, Wang PH. Postoperative maintenance levonorgestrel-releasing intrauterine system and endometrioma recurrence: a randomized controlled study. Am J Obstet Gynecol. 2017 Jun;216(6):582.e1-582.e9. doi: 10.1016/j.ajog.2017.02.008. Epub 2017 Feb 15.'}, {'pmid': '20192953', 'type': 'BACKGROUND', 'citation': 'Carey AJ, Beagley KW. Chlamydia trachomatis, a hidden epidemic: effects on female reproduction and options for treatment. Am J Reprod Immunol. 2010 Jun;63(6):576-86. doi: 10.1111/j.1600-0897.2010.00819.x. Epub 2010 Feb 28.'}, {'pmid': '33160356', 'type': 'BACKGROUND', 'citation': 'Chee WJY, Chew SY, Than LTL. Vaginal microbiota and the potential of Lactobacillus derivatives in maintaining vaginal health. Microb Cell Fact. 2020 Nov 7;19(1):203. doi: 10.1186/s12934-020-01464-4.'}, {'pmid': '27373840', 'type': 'BACKGROUND', 'citation': 'Smith SB, Ravel J. The vaginal microbiota, host defence and reproductive physiology. J Physiol. 2017 Jan 15;595(2):451-463. doi: 10.1113/JP271694. Epub 2016 May 5.'}, {'pmid': '33996627', 'type': 'BACKGROUND', 'citation': 'Dunlop AL, Satten GA, Hu YJ, Knight AK, Hill CC, Wright ML, Smith AK, Read TD, Pearce BD, Corwin EJ. Vaginal Microbiome Composition in Early Pregnancy and Risk of Spontaneous Preterm and Early Term Birth Among African American Women. Front Cell Infect Microbiol. 2021 Apr 29;11:641005. doi: 10.3389/fcimb.2021.641005. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Mycoplasma, chlamydia, and gonococcal infection of the female lower genital tract can lead to infertility and various adverse pregnancy outcomes. The lower genital tract bacterial community status type (CST) is closely related to genital tract infection and reproductive health. However, there is a need for a rapid, accurate, stable, and economical detection method to detect the above pathogens and CST at the same time, so there is also a need for evaluation of the correlation between each pathogen infection and CST. Matrix assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) is more stable and accurate than traditional detection methods such as culture and staining. It can simultaneously detect a variety of microorganisms and their subtypes, while the high-throughput sequencing method is faster and more economical, which is suitable for detecting multiple microorganisms in clinical practice. The research group has established a perfect MALDI-TOF MS platform in the early stage and put it into clinical testing. This project will establish a new rapid detection method for lower genital tract microorganisms based on MALDI-TOF MS. Then, examine the lower genital tract microecology of infertile patients and healthy women using the newly developed method. At last, analyze the correlation between pathogen infection, CST status, and infertility. This project will solve the practical work needs of clinicians for a comprehensive assessment of female lower genital tract CST and common pathogen infection and fill in the technical gaps in the microbial examination of the lower genital tract.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women of childbearing age who can spontaneous pregnancy and infertile women', 'genderDescription': 'The target disease of this study is infertility, so its not based on self-representation of gender identity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCase group:\n\n1\\) Female aged 18-40 2) Regular menstrual cycle 2) Conform to the clinical diagnosis of infertility 3) No sexual life 3 days before the examination control group:\n\n1. Female aged 18-40\n2. Regular menstrual cycle\n3. Patients who did pre-pregnancy consultation in our hospital, pregnant at the time of 3-month follow-up\n4. No sexual life 3 days before the examination -\n\nExclusion Criteria:\n\nCase group:\n\n1. Infertility due to malformation of reproductive tract\n2. Infertility caused by endocrine factors such as polycystic ovary syndrome, premature ovarian failure and severe hyperthyroidism\n3. Infertility due to male factors\n4. Patients with malignant tumors\n5. Patients with autoimmune diseases\n6. Patients with severe heart, kidney and other basic diseases\n7. Patients who consumed antibiotics 3 days before the examination\n8. Have the habit of smoking and drinking\n\nControl group:\n\n1. Pregnancy by various assisted reproductive means\n2. Patients with malignant tumors\n3. Patients with autoimmune diseases\n4. Patients with severe heart, kidney and other basic diseases\n5. Patients who consumed antibiotics 3 days before the examination\n6. Have the habit of smoking and drinking'}, 'identificationModule': {'nctId': 'NCT05678751', 'briefTitle': 'Rapid Detection Method for Microorganisms in the Lower Genital Tract', 'organization': {'class': 'OTHER', 'fullName': "Shenzhen Second People's Hospital"}, 'officialTitle': 'Establishment of a Rapid Detection Method for Microorganisms in the Lower Genital Tract Using MALDI-TOF MS and Its Clinical Application in Infertility', 'orgStudyIdInfo': {'id': 'yzy_00159'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'case group', 'description': 'patients with infertility', 'interventionNames': ['Diagnostic Test: lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)']}, {'label': 'control group', 'description': 'women that are capable of spontaneous intrauterine pregnanc', 'interventionNames': ['Diagnostic Test: lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)']}], 'interventions': [{'name': 'lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection of pathogens and microorganisms in the lower genital tract of infertile and spontaneously pregnant women by a new MALDI-TOF MS-based technique', 'armGroupLabels': ['case group', 'control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yu Chen, M.D.', 'role': 'CONTACT', 'email': 'chenyu2017@email.szu.edu.cn', 'phone': '+86 0755 83366388', 'phoneExt': '3048'}], 'overallOfficials': [{'name': 'Zhiying Yu, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Shenzhen Second People's Hospital"}, {'name': 'Wenlan Liu, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Shenzhen Second People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Because this study involves private information related to patient reproduction, we may not fully disclose subject details, but we will evaluate applicants and give non-private data by email, etc., when necessary.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shenzhen Second People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}