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Ovarian Follicle Function in Patients with Premature Ovarian Failure - Article


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Infertility


Clinical Trial: Ovarian Follicle Function in Patients with Premature Ovarian Failure

This study is currently recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

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 Treatment or Intervention
Amenorrhea
Hypoaldosteronism
Hypogonadism
Infertility
Premature Ovarian Failure
 Drug: OCRH

MedlinePlus related topics:  Adrenal Gland Disorders;   Endocrine Diseases;   Infertility;   Menstruation;   Premature Ovarian Failure

Study Type: Observational
Study Design: Screening

Further Study Details: 

Expected Total Enrollment:  1000

Study start: May 12, 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

Genders Eligible for Study:  Female

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.

Location and Contact Information


Maryland
      National Institute of Child Health and Human Development (NICHD), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Publications

Nelson LM, Anasti JN, Kimzey LM, Defensor RA, Lipetz KJ, White BJ, Shawker TH, Merino MJ. Development of luteinized graafian follicles in patients with karyotypically normal spontaneous premature ovarian failure. J Clin Endocrinol Metab. 1994 Nov;79(5):1470-5.

Anasti JN, Flack MR, Froehlich J, Nelson LM. The use of human recombinant gonadotropin receptors to search for immunoglobulin G-mediated premature ovarian failure. J Clin Endocrinol Metab. 1995 Mar;80(3):824-8.

Kim TJ, Anasti JN, Flack MR, Kimzey LM, Defensor RA, Nelson LM. Routine endocrine screening for patients with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1997 May;89(5 Pt 1):777-9.

Study ID Numbers:  910127; 91-CH-0127
Record last reviewed:  March 30, 2004
Last Updated:  November 23, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001275
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: December 9, 2005
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