Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 6:00 AM
Study NCT ID:
NCT00006156
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2000-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Study for Development of an Early Test for Ovarian Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}, {'id': 'D008594', 'term': 'Menopause, Premature'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nelsonl@mail.nih.gov', 'phone': '+1 301 402 6608', 'title': 'Nelson, Lawrence Merle', 'organization': 'National Institute of Child Health and Human Development'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Adverse Events Not Collected', 'description': 'Adverse Events Not Collected', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug - FSH'}, {'id': 'OG001', 'title': 'Control'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '50.7', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '48.8', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': '24 Hours', 'categories': [{'measurements': [{'value': '96.6', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '47.7', 'spread': '10.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'unitOfMeasure': 'participants', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Drug - FSH'}, {'id': 'OG001', 'title': 'Control'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '29.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '25.0', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': '24 Hours', 'categories': [{'measurements': [{'value': '70.8', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '28.3', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'unitOfMeasure': 'participants', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Drug - FSH'}, {'id': 'FG001', 'title': 'Control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Drug - FSH'}, {'id': 'BG001', 'title': 'Control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-28', 'studyFirstSubmitDate': '2000-08-09', 'resultsFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2000-08-09', 'lastUpdatePostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-28', 'studyFirstPostDateStruct': {'date': '2000-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels', 'timeFrame': '24 hours'}]}, 'conditionsModule': {'keywords': ['Ovarian Failure', 'Ovary', 'Aging', 'Healthy Volunteer', 'Primary Ovarian Insufficiency(POI)', 'Premature Menopause', 'Premature Ovarian Failure (POF)'], 'conditions': ['Healthy', 'Premature Ovarian Failure']}, 'referencesModule': {'references': [{'pmid': '9464713', 'type': 'BACKGROUND', 'citation': 'Anasti JN, Kalantaridou SN, Kimzey LM, Defensor RA, Nelson LM. Bone loss in young women with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1998 Jan;91(1):12-5. doi: 10.1016/s0029-7844(97)00583-8.'}, {'pmid': '3960433', 'type': 'BACKGROUND', 'citation': 'Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6.'}, {'pmid': '8671489', 'type': 'BACKGROUND', 'citation': 'Faddy MJ, Gosden RG. A model conforming the decline in follicle numbers to the age of menopause in women. Hum Reprod. 1996 Jul;11(7):1484-6. doi: 10.1093/oxfordjournals.humrep.a019422.'}]}, 'descriptionModule': {'briefSummary': "This purpose of this study is to gain information about normal ovarian function that will be useful in developing a test for early detection of ovarian failure. The ovaries produce female hormones, such as estrogen, that are important in maintaining a woman's health. When the ovaries do not work properly, problems can develop. Unfortunately, there is no test that can detect ovarian failure early in its course. By the time premature ovarian failure is diagnosed in young women, two-thirds have already developed osteopenia (loss of some bone mass) and nearly one in ten have osteoporosis, a greater loss of bone mineral density that weakens bones and increases the risk of fractures.\n\nWomen with normal ovarian function ages 18 to 55 and postmenopausal women 60 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests and vaginal ultrasound examination. For the ultrasound study, a probe that emits sound waves is inserted into the vagina, and the sound waves are converted to form images of the ovaries. The procedure is done with an empty bladder and takes about 10 minutes. After this screening visit (Visit 1), those enrolled in the study will return to the NIH Clinical Center for the following additional procedures:\n\nVisit 2-Will be scheduled between days 3 and 5 of the menstrual cycle (for women who are still menstruating). Participants will have blood tests to measure hormone levels and to check for pregnancy, and will have another transvaginal ultrasound examination. They will then receive an injection of a synthetic form of follicle stimulating hormone (FSH), a hormone the body makes normally.\n\nVisits 3 and 4-Will be scheduled 24 and 36 hours after the FSH injection given during Visit 2 for collection of blood samples.\n\nVisit 5-Will be scheduled 48 hours after the FSH injection for additional blood sampling and a final transvaginal ultrasound examination.", 'detailedDescription': 'This is a pilot project to test the feasibility of developing an FSH stimulation test. There is a need for a sensitive and specific marker to detect ovarian insufficiency early in its course. FSH stimulates inhibin B production by the granulosa cells of the cohort of ovarian follicles; serum inhibin B in turn participates in the negative feedback loop regulating FSH secretion. This protocol is characterizing the normal FSH-stimulated serum inhibin B response to a single subcutaneous injection of 300 IU human recombinant FSH given on day 2 to 4 of the menstrual cycle. In preliminary analysis under this protocol we have demonstrated that FSH-stimulated serum inhibin B levels measured at 24 hours after injection is a more robust marker of functional ovarian age than ovarian follicle count by transvaginal ultrasound, basal serum Mullerian Inhibiting Substance (MIS) levels, or basal serum FSH levels. Multiple regression analysis has revealed that FSH-stimulated inhibin B, FSH-stimulated estradiol, and basal FSH contribute significantly to an ability to predict functional ovarian age (as approximated by chronological age). The resulting regression equation relating these three parameters with age has a correlation coefficient of 0.742 and a coefficient of determination of 0.551. The protocol is now evaluating the reproducibility of this test and the feasibility of generating normative data in young women between the ages of 18 and 25. The results of this study may define parameters that could lead to earlier diagnosis and treatment of premature ovarian insufficiency.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nA. Women with normal ovarian function:\n\nAge 18 to 55.\n\nNormal body mass index (18-30 kg/m(2)).\n\nNormal menstrual cycles (between 25-35 days in length).\n\nOvulatory serum progesterone concentrations (in excess of 6 ng/mL in the menstrual cycle just preceding the study cycle).\n\nB. Postmenopausal women (to serve as negative controls):\n\nGreater than or equal to 60 years of age.\n\nProven fertility (as evidenced by a history of pregnancy regardless of outcome).\n\nNormal body mass index (18-30 kg/m(2)).\n\nNaturally menopausal: amenorrhea for at least one year; serum FSH greater than 40 IU/mL.\n\nC. Women carriers of FMR1 premutations:\n\nAge 18 to 40.\n\n50 to 200 CGG repeats.\n\nNormal menstrual cycles (between 25-35 days in length).\n\nHave previously had genetic counseling regarding their FMR1 status.\n\nEXCLUSION CRITERIA:\n\nHistory of infertility or infertility in a first degree relative.\n\nAcute or chronic disease.\n\nMenopause due to surgery, radiation, or chemotherapy.\n\nCurrent use of oral contraceptives or hormone replacement therapy, or use of these agents within the previous 3 months.\n\nUse within the previous three months of any medication known to affect the hypothalamic-pituitary-ovarian axis (including over-the-counter and alternative medicines).\n\nHistory of excessive exercise (greater than 10 hours a week).\n\nGirls will be excluded because there are no data regarding FSH use in children.\n\nSmokers.\n\nPregnant.\n\nBreast feeding.\n\nPersistent ovarian masses.\n\nHistory of tumors of the ovary, breast, uterus, hypothalamus, or pituitary.\n\nHistory of breast or endometrial cancer.\n\nHistory of hypersensitivity to recombinant FSH or any one of its excipients.'}, 'identificationModule': {'nctId': 'NCT00006156', 'briefTitle': 'Feasibility Study for Development of an Early Test for Ovarian Failure', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'FSH-Stimulated Inhibin B as a Marker for Early Ovarian Insufficiency', 'orgStudyIdInfo': {'id': '000189'}, 'secondaryIdInfos': [{'id': '00-CH-0189'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Control for FSH stimulation test', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Drug: FSH', 'description': 'FSH Stimulation Test', 'interventionNames': ['Drug: Drug: FSH']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': 'No injection of FSH', 'armGroupLabels': ['Control']}, {'name': 'Drug: FSH', 'type': 'DRUG', 'description': 'FSH Stimulation Test', 'armGroupLabels': ['Drug: FSH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lawrence Nelson, M.D.', 'investigatorAffiliation': 'National Institutes of Health Clinical Center (CC)'}}}}