ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  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.
Study NCT00001275.   Last updated on July 18, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Ovarian Follicle Function in Patients With Premature Ovarian Failure
Official Title  Ovarian Follicle Function in Patients With Premature Ovarian Failure
Brief Summary

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.

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.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Amenorrhea
Hypoaldosteronism
Hypogonadism
Infertility
Premature Ovarian Failure
Intervention 
MEDLINE PMIDs 7962345,   7883837,   9166320
Links NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1000
Start Date  May 1991
Completion Date
Eligibility 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.

Gender Female
Ages 18 Years to 42 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010        
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001275
Organization ID 910127
Secondary IDs †† 91-CH-0127
Study Sponsor  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date March 2008
First Received Date  November 3, 1999
Last Updated Date July 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers