Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-23 @ 6:17 PM
Study NCT ID:
NCT00646568
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2008-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve
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': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2008-03-17', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'androgens levels after stimulation in relation to the ovarian reserve', 'timeFrame': '2 weeks'}]}, 'conditionsModule': {'keywords': ['IVF', 'ovarian reserve', 'androgens', 'thecal cells', 'Fertility Agents, Female'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'In an era of delayed fertility plans, there is an increasing need for a reliable method to predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B, Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and number of antral follicles are non-specific and with questionable reliability. The biochemical tests represent the function of production of androgens, as a predictor of ovarian reserve, has not been tested yet.\n\nWorking hypothesis and aims: testing the prognostic capability of hCG stimulating test of theca cells for estimating the ovarian reserve, and by that to calculate better the chance for IVF cycle success', 'detailedDescription': '20 women \\>40 years old and 20 women \\<35 years old, attended to our IVF unit were included in the study. Another 20 other young women (\\<35 years) with poor response in previous IVF cycles will be participate. All participants received a single hCG 10000 IU injection on cycle day 2-4. Hormone levels of LH, FSH, E2, P, Testosterone, Androstendione and 17-OHP were taken prior to the injection and on days 1, 3 and 7 afterwards. hCG induced hormone levels will be compared with IVF results'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women on IVF cycle\n\nExclusion Criteria:\n\n* Any allergy to injection of human chorionic gonadotropin before'}, 'identificationModule': {'nctId': 'NCT00646568', 'briefTitle': 'Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'hCG Stimulating Test of the Thecal Cells to Evaluate the Ovarian Reserve', 'orgStudyIdInfo': {'id': 'hcgstimtest-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 's.c. human chorionic gonadotropin (Pregnyl)', 'type': 'DRUG', 'description': 'S.C. Pregnyl 10000 IU once'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12000', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Assaf Ben-Meir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Arik Tzukert', 'oldOrganization': 'Hadassah Medical Center'}}}}