Ovarian Follicle Function in Patients With Premature Ovarian Failure
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Purpose
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 prematurem ovarian failure. The findings will determine patients' suitability for specifically focused therapeutic research protocols.
| Condition |
|---|
|
Amenorrhea Hypoaldosteronism Hypogonadism Infertility Premature Ovarian Failure |
| Study Type: | Observational |
| Official Title: | Ovarian Follicle Function in Patients With Premature Ovarian Failure |
| Enrollment: | 1109 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
Women 18 to 45 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.
Contacts and Locations| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Lawrence M Nelson, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00001275 History of Changes |
| Other Study ID Numbers: | 910127, 91-CH-0127 |
| Study First Received: | November 3, 1999 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Infertility Menopause Estrogen Ovulation Amenorrhea Hypergonadotropic Hypogonadism |
Young Women Gonadal Steroid Deficiency Mineralocorticoid Deficiency Premature Ovarian Failure POF |
Additional relevant MeSH terms:
|
Infertility Amenorrhea Hypoaldosteronism Hypogonadism Menopause, Premature Primary Ovarian Insufficiency Menstruation Disturbances Pathologic Processes |
Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Gonadal Disorders Genital Diseases, Male Genital Diseases, Female Ovarian Diseases Adnexal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013