Ovarian Follicle Function in Patients With Premature Ovarian Failure

This study is currently recruiting participants.

Verified by National Institutes of Health Clinical Center (CC), February 2009

First Received: November 3, 1999 Last Updated: June 9, 2009 History of Changes

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001275

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

Resource links provided by NLM:

MedlinePlus related topics: Infertility Premature Ovarian Failure

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	1000
Study Start Date:	May 1991
Estimated Primary Completion Date:	April 1995 (Final data collection date for primary outcome measure)

Detailed Description:

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 42 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001275

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

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
Study First Received:	November 3, 1999
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00001275 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Menopause
Estrogen
Infertility
Ovulation
Amenorrhea
Hypergonadotropic Hypogonadism

Young Women
Gonadal Steroid Deficiency
Mineralocorticoid Deficiency
Premature Ovarian Failure
POF

Study placed in the following topic categories:

Infertility
Estrogens
Adrenal Insufficiency
Adrenal Gland Hypofunction
Gonadal Disorders
Mineralocorticoids
Amenorrhea
Adrenal Gland Diseases
Endocrine System Diseases
Ovarian Failure, Premature

Ovarian Diseases
Hypoadrenalism
Genital Diseases, Male
Hypoaldosteronism
Genital Diseases, Female
Hypogonadism
Menstruation Disturbances
Endocrinopathy
Menopause

Additional relevant MeSH terms:

Infertility
Adrenal Insufficiency
Gonadal Disorders
Amenorrhea
Adrenal Gland Diseases
Endocrine System Diseases
Ovarian Failure, Premature
Ovarian Diseases

Genital Diseases, Male
Adnexal Diseases
Hypoaldosteronism
Genital Diseases, Female
Hypogonadism
Pathologic Processes
Menstruation Disturbances

ClinicalTrials.gov processed this record on July 02, 2009