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Ovarian Follicle Function in Patients with Premature Ovarian Failure



Ovarian Follicle Function in Patients with Premature Ovarian Failure

For Condition: Amenorrhea,Hypoaldosteronism,Hypogonadism,Infertility,Premature Ovarian Failure
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type:
  Observational, Screening
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION 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.
Total Enrollment: 1000

Location and Contact Information:

National Institute of Child Health and Human Development (NICHD) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:
  910127;  91-CH-0127
Study Start Date: May 12, 1991
Record last reviewed: May 5, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001275

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1. Prevention of Osteoporosis in Men with Prostate Cancer

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3. Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle

4. Effects on the Brain of Lupron Induced Hypogonadotropic Hypogonadism with and without Testosterone Replacement

5. Testosterone and Growth Hormone for Bone Loss in Men

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