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Protocol Details

Ovarian Follicle Function in Patients with Premature Ovarian Failure

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

91-CH-0127

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Female
Min Age: 18
Max Age: 42

Referral Letter Required

Yes

Population Exclusion(s)

Male;
Children

Special Instructions

Currently Not Provided

Keywords

Menopause;
Estrogen;
Infertility;
Ovulation;
Amenorrhea;
Hypergonadotropic Hypogonadism;
Young Women;
Gonadal Steroid Deficiency;
Mineralocorticoid Deficiency

Recruitment Keyword(s)

Premature Ovarian Failure;
POF

Condition(s)

Amenorrhea;
Hypoaldosteronism;
Hypogonadism;
Infertility;
Premature Ovarian Failure

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Child Health and Human Development

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.

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Eligibility

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.


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Citations:

Development of luteinized Graafian follicles in patients with karyotypically normal spontaneous premature ovarian failure

The use of human recombinant gonadotropin receptors to search for IgG mediated premature ovarian failure

Routine endocrine screening for patients with karyotypically normal spontaneous premature ovarian failure

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lawrence M. Nelson, M.D.
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 10
Room 1E3140
10 Center Drive
Bethesda, Maryland 20892
(301) 496-5800
nelsonl@cc1.nichd.nih.gov

Vien H. Vanderhoof, C.R.N.P.
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 10
Room 1-3140
10 Center Drive
Bethesda, Maryland 20892
(301) 496-4686
vanderhv@mail.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00001275

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