Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Ovarian Follicle Function in Patients With Premature Ovarian Failure
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), March 2008
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

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
Amenorrhea
Hypoaldosteronism
Hypogonadism
Infertility
Premature Ovarian Failure

MedlinePlus related topics: Infertility Premature Ovarian Failure
U.S. FDA Resources
Study Type: Observational
Official Title: Ovarian Follicle Function in Patients With Premature Ovarian Failure

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

Estimated Enrollment: 1000
Study Start Date: May 1991
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
  More Information

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

Publications:
Study ID Numbers: 910127, 91-CH-0127
Study First Received: November 3, 1999
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00001275  
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
Adrenal Insufficiency
Gonadal Disorders
Amenorrhea
Adrenal Gland Diseases
Endocrine System Diseases
Ovarian Failure, Premature
Ovarian Diseases
Hypoadrenalism
Genital Diseases, Male
Adrenal gland hypofunction
Hypoaldosteronism
Genital Diseases, Female
Hypogonadism
Menstruation Disturbances
Endocrinopathy
Menopause

Additional relevant MeSH terms:
Pathologic Processes
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009