Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT04639505
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2020-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of New AMH Test Method for Ovarian Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D049449', 'term': 'Luminescence'}], 'ancestors': [{'id': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 454}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2020-11-11', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the AMH（CLIA） cutoff value of low and high ovarian response', 'timeFrame': 'the day of oocytes retrieved，about three months after AMH test', 'description': 'the poor ovarian response :the number of retrieved oocyte ≤ 3,the high ovarian response :the number of retrieved oocyte ≥ 15'}], 'secondaryOutcomes': [{'measure': 'Number of oocytes retrieved', 'timeFrame': '34-36 hours after hCG trigger，about three months after AMH test', 'description': 'the number of oocytes retrieved after hCG trigger'}, {'measure': 'the serum AMH level', 'timeFrame': 'any day of the menstrual cycle, about three months after study starting', 'description': 'anti-muller hormone'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility', 'AMH']}, 'descriptionModule': {'briefSummary': "In China, the incidence of infertility is about 15%, and patients need to use assisted reproductive technology (ART) to obtain pregnancy. It is particularly important to accurately predict the patient's ovarian response before initiating controlled ovulation hyperstimulation (COH). At present, the commonly used AMH detection method is enzyme-linked immunoassay (ELISA), and it has obtained the normal reference range for ovarian response. In recent years, with the development of detection technology, chemiluminescence immunoassay（CLIA） detection reagents have been successively used for the detection of AMH. However, there are few studies on the comparison of these two detection methods. The predictive value of the new method on ovarian response was lack. Therefore, by comparing the two methods of ELISA and CLIA detection of AMH levels in this study, the predictive value of poor ovarian response (the number of retrieved oocyte ≤ 3) and high response (the number of retrieved oocyte ≥ 15) in IVF/ICSI stimulation cycle was analyzed. In order to provide more reference basis for individualized COH, the AMH cutoff value of low and high ovarian response by the new method predicts was analyzed. At the same time, the prediction value of the two methods is compared to determine whether the new CLIA is suitable for clinical application."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'infertility females', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The first IVF/ICSI COH cycle;\n* the causes of infertility :fallopian tube factors and/or male factors;\n\nExclusion Criteria:\n\n* Endometriosis;\n* PCOS;\n* Adenomyosis;\n* PGT cycle because of the female chromosome abnormality or genetic abnormality;\n* FET cycle;\n* Malignant tumor patient.'}, 'identificationModule': {'nctId': 'NCT04639505', 'briefTitle': 'Predictive Value of New AMH Test Method for Ovarian Response', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive & Genetic Hospital of CITIC-Xiangya'}, 'officialTitle': 'Predictive Value of New AMH Test Method for Ovarian Response in Patients With IVF/ICSI', 'orgStudyIdInfo': {'id': 'P2020004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ELISA', 'description': 'ELISA kit detecting the serum AMH level', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Chemiluminescence', 'description': 'CLIA method detecting the serum AMH level', 'interventionNames': ['Diagnostic Test: Chemiluminescence']}], 'interventions': [{'name': 'ELISA', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['experimental group'], 'description': 'ELISA kit detecting the serum AMH level', 'armGroupLabels': ['ELISA']}, {'name': 'Chemiluminescence', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['control group'], 'description': 'CLIA method detecting the serum AMH level', 'armGroupLabels': ['Chemiluminescence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Reproductive & Genetic Hospital of CITIC-XIANGYA', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Fei Gong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive & Genetic Hospital of CITIC-Xiangya'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive & Genetic Hospital of CITIC-Xiangya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}