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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001275 |
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.
Condition |
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Amenorrhea Hypoaldosteronism Hypogonadism Infertility Premature Ovarian Failure |
Study Type: | Observational |
Official Title: | Ovarian Follicle Function in Patients With Premature Ovarian Failure |
Estimated Enrollment: | 1000 |
Study Start Date: | May 1991 |
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.
Ages Eligible for Study: | 18 Years to 42 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 910127, 91-CH-0127 |
Study First Received: | November 3, 1999 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00001275 |
Health Authority: | United States: Federal Government |
Menopause Estrogen Infertility Ovulation Amenorrhea Hypergonadotropic Hypogonadism |
Young Women Gonadal Steroid Deficiency Mineralocorticoid Deficiency Premature Ovarian Failure POF |
Infertility Adrenal Insufficiency Gonadal Disorders Amenorrhea Adrenal Gland Diseases Endocrine System Diseases Ovarian Failure, Premature Ovarian Diseases Hypoadrenalism |
Genital Diseases, Male Adrenal gland hypofunction Hypoaldosteronism Genital Diseases, Female Hypogonadism Menstruation Disturbances Endocrinopathy Menopause |
Pathologic Processes Adnexal Diseases |