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| Descriptive Information Fields | |||||||||
| Brief Title † | Ovarian Follicle Function in Patients With Premature Ovarian Failure | ||||||||
| Official Title † | Ovarian Follicle Function in Patients With Premature Ovarian Failure | ||||||||
| Brief Summary | Premature ovarian failure may be the result of the destruction of eggs in the ovaries. Some patients experience complete destruction of all eggs within the ovaries. In these cases, no treatment will restore egg development. However, some patients experience a condition known as premature autoimmune ovarian failure. In these cases eggs still remain in the ovaries, but they are prevented from working normally by the body's own immune system. This study was designed to evaluate patients with premature ovarian failure. It will provide researchers with information that may be used later in other studies related to this condition. In addition, patients participating in this study may be selected for other studies that may benefit them directly. |
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| Detailed Description | No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous premature ovarian failure. We know that one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This is a diagnostic omnibus protocol that permits baseline clinical evaluation of patients with premature ovarian failure. The findings will determine patients' suitability for specifically focused therapeutic research protocols. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | |||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Amenorrhea Hypoaldosteronism Hypogonadism Infertility Premature Ovarian Failure |
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| Intervention † | |||||||||
| MEDLINE PMIDs | 7962345, 7883837, 9166320 | ||||||||
| Links | NIH Clinical Center Detailed Web Page  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 1000 | ||||||||
| Start Date † | May 1991 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † |
Women 18 to 42 years of age with premature ovarian failure who meet the following requirements will be candidates for the study: 1) at least a four month history of amenorrhea not due to pregnancy, and 2) at least two documented serum FSH levels or two documented LH levels in the menopausal range for the corresponding assay (greater than or equal to 20 U/ml for FSH and greater than or equal to15 U/L for LH in the current Clinical Center assays). EXCLUSION CRITERIA: Women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian failure will not be candidates. |
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| Gender | Female | ||||||||
| Ages | 18 Years to 42 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00001275 | ||||||||
| Organization ID | 910127 | ||||||||
| Secondary IDs †† | 91-CH-0127 | ||||||||
| Study Sponsor † | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Collaborators †† | |||||||||
| Investigators † | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | November 3, 1999 | ||||||||
| Last Updated Date | July 18, 2008 | ||||||||
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