Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-03-25 @ 12:33 AM
Study NCT ID:
NCT02331758
Status:
UNKNOWN
Last Update Posted:
2015-01-06
First Post:
2014-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence Factors of Ovarian Response in PCOS Patients With IVF-ET Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'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': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-02', 'studyFirstSubmitDate': '2014-12-31', 'studyFirstSubmitQcDate': '2015-01-02', 'lastUpdatePostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oocyte number', 'timeFrame': '3 Month', 'description': 'Affect the outcome of IVF-ET treatment'}], 'secondaryOutcomes': [{'measure': 'Success Rate', 'timeFrame': '3 Month', 'description': 'The success rate of IVF-ET treatment elevated'}, {'measure': 'OHSS complication', 'timeFrame': '3 Month', 'description': 'The number of OHSS patients reduced'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the factors which affect ovarian response of PCOS patients with IVF-ET treatment, in order to provide predictive clinical index for the outcome of IVF-ET treatment in PCOS patients. After figuring out the controllable factors, researchers would be able to educate PCOS patients and improve the success rate while reducing the incidence of complications during the treatment at the same time.', 'detailedDescription': 'Statistics of PCOS patients like age, BMI index and others would be collected. Through distributing questionnaires and query of past cases and collecting data recorded during the ovulation process like monitoring fluctuations in blood and ultrasonic monitoring results, researchers obtain the risk factors of the occurence of Ovarian Hyperstimulation Syndrome(OHSS) in IVF-ET treatment in PCOS patients and set up an OHSS prediction model, choose controllable factors in order to make up guidance and have intervention on patients with PCOS accordingly. The investigators expect this could improve the success rate of IVF-ET treatment in patients with PCOS, provide clues and assist to reduce the risk of the therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of PCOS\n* Long schedule time of Luteal phase\n* Available to trace\n* Normal Prolactin level with contraceptive treatment in recent 3 months\n\nExclusion Criteria:\n\n* Unwilling to participate'}, 'identificationModule': {'nctId': 'NCT02331758', 'briefTitle': 'The Influence Factors of Ovarian Response in PCOS Patients With IVF-ET Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'The Influence Factors of Ovarian Response in Polycystic Ovary Syndrome Patients(PCOS) With In Vitro Fertilization and Embryo Transfer (IVF-ET) Treatment', 'orgStudyIdInfo': {'id': '2014180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle counseling', 'description': 'The investigators use several methods to educate patients of controllable factors like lifestyle counseling, and monitor the factors like BMI and other index until the statistics become normal.', 'interventionNames': ['Behavioral: Lifestyle Counseling']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'Patients without any intervention and still have abnormal factors like BMI, etc.'}], 'interventions': [{'name': 'Lifestyle Counseling', 'type': 'BEHAVIORAL', 'description': 'The investigators do lifestyle counseling for PCOS patients and monitor the factors to normal level, like BMI, serum index etc.', 'armGroupLabels': ['Lifestyle counseling']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing University Health Science Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Yilei He', 'investigatorFullName': 'Yilei He', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}