Status:
COMPLETED
Steroid Therapy in Autoimmune Premature Ovarian Failure
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Autoimmune Disease
Infertility
Eligibility:
FEMALE
18-39 years
Brief Summary
No therapy for infertile patients with premature ovarian failure has been proven effective. Some anecdotal reports have suggested that high dose, long term prednisone (steroid) therapy may be useful i...
Detailed Description
Autoimmune oophoritis is a distinct clinical entity and a known cause of premature ovarian failure. It is characterized by the presence of circulating adrenal antibodies. No therapy for infertile pati...
Eligibility Criteria
- INCLUSION/EXCLUSION CRITERIA:
Women 18 to 39 years of age with premature ovarian failure who meet the following requirements will be candidates for the study:
At least a four month history of amenorrhea not due to pregnancy,
Clearly elevated gonadotropins with a serum FSH greater than or equal to 40 IU/L on two separate occasions at least one month apart,
Positive adrenal or ovarian antibodies demonstrated by indirect immuno-fluorescence using monkey tissue as substrate or other laboratory evidence of steroidogenic cell autoimmunity such as the presence of antibodies against 21-hydroxylase,
No evidence for genetic, metabolic, toxic, or iatrogenic cause of the ovarian failure,
No medical contraindication to glycocorticoid therapy,
No glycocorticoid therapy taken in the past year (patients on appropriate replacement therapy for Addison's disease are not excluded),
No medical contraindication to pregnancy.
Key Trial Info
Start Date :
July 10 1992
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00001306
Start Date
July 10 1992
End Date
December 12 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892