Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-23 @ 9:57 PM
Study NCT ID:
NCT02265861
Status:
COMPLETED
Last Update Posted:
2014-10-16
First Post:
2014-10-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Response of VEGF and AT-II to HCG in PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D016471', 'term': 'Ovarian Hyperstimulation 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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-10', 'studyFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ)', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polycystic ovary syndrome; Vascular endothelial growth factor; Angiotensin-Ⅱ; Ovarian hyperstimulation syndrome'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '25780518', 'type': 'DERIVED', 'citation': 'Qu J, Che Y, Xu P, Xia Y, Wu X, Wang Y. The Higher Response of Vascular Endothelial Growth Factor and Angiotensin-II to Human Chorionic Gonadotropin in Women with Polycystic Ovary Syndrome. Int J Fertil Steril. 2015 Jan-Mar;8(4):373-8. doi: 10.22074/ijfs.2015.4176. Epub 2015 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'This research is to investigate the response of vascular active factors, vascular endothelial growth factor (VEGF) and angiotensin-Ⅱ (AT-Ⅱ) to ovary stimulation during 24h in patients with polycystic ovary syndrome (PCOS).Controled prospective clinical study involved 60 women undergoing in vitro fertilization. Fifty-two patients with PCOS and 8 control cases were stimulated with human chorionic gonadotropin (HCG) during the early follicular phase of the menstrual cycle (4st to 7th days of the cycle).The blood was sampled before the injection (0 hour) and at the 3, 6, 12, 18 and 24 hours points after the stimulation. VEGF, AT-Ⅱ were measured by radioimmunoassay.', 'detailedDescription': 'After ovary stimulation, the level of VEGF in typical PCOS patients is obviously increased at the 3hs time point (p\\<0.05), while there is no difference with VEGF at all other time point among the four groups. As for AT-Ⅱ, before and after the ovary stimulation, at all time points, the AT-Ⅱ levels in serum of patients with different phenotypes of PCOS by Rotterdam criteria are all higher than the controls without PCOS. After the ovary stimulation, AT-Ⅱ in typical PCOS patients is obviously increased at 3hs time point, p\\<0.05. The response of VEGF and AT-Ⅱ to HCG in women with typical PCOS is higher in 24 hours after the stimulation during the early follicular phase. The response to the stimulation is different in patients with different phenotypes of PCOS by Rotterdam criteria. Serum VEGF and AT-Ⅱ levels as a possible contributor to a great risk of developing OHSS in patients with typical PCOS during the early follicular phase in 24 hours after the ovary stimulation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A total of 60 women were recruited and divided into four groups by Rotterdam criteria according to three typical characters:\n\n 1. biochemical characteristics of hyperandrogenism (HA)\n 2. chronic anovulation\n 3. polycystic ovary morphology (PCO).\n\nExclusion Criteria:\n\n* All women were matched for age (\\<35 yr).\n* All subjects were screened, and no other endocrine disturbances (thyroid, adrenal) or medical illnesses were found.\n* All the patients did not have any hormonal preparation during the 3 months preceding the study.'}, 'identificationModule': {'nctId': 'NCT02265861', 'briefTitle': 'Response of VEGF and AT-II to HCG in PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University School of Medicine'}, 'officialTitle': 'The Higher Response of Vascular Endothelial Growth Factor and Angiotensin-II to Human Chorionic Gonadotropin in Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'NanjingUSMwy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'typical PCOS', 'interventionNames': ['Drug: HCG']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'PCOS without PCO', 'interventionNames': ['Drug: HCG']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'PCOS without HA', 'interventionNames': ['Drug: HCG']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Control', 'interventionNames': ['Drug: HCG']}], 'interventions': [{'name': 'HCG', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wang Yong', 'investigatorAffiliation': 'Nanjing University School of Medicine'}}}}