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Search / Trial NCT00001306

Steroid Therapy in Autoimmune Premature Ovarian Failure

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Nov 3, 1999

Trial Information

Current as of March 23, 2025

Completed

Keywords

Infertility Ovulation Autoimmune Follicle Menopause Biopsy Glucocorticoids Premature Ovarian Failure Amenorrhea Ovarian Failure Pof

ClinConnect Summary

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 patients with premature ovarian failure due to autoimmune oophoritis has been proven effective by prospective controlled study. Anecdotal reports have suggested that high-dose, long-term prednisone therapy may be useful in treating autoimmune ovarian failure. However, prednisone, when used in high-dose for a long-term has substantial side effects, including aseptic necrosis of bone requiring major ...

Gender

FEMALE

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.

About Eunice Kennedy Shriver National Institute Of Child Health And Human Development (Nichd)

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is a prominent research agency within the National Institutes of Health (NIH), dedicated to advancing the health and well-being of children, families, and individuals across the lifespan. NICHD supports a wide range of clinical trials and research initiatives aimed at understanding the complex biological, behavioral, and environmental factors that influence human development and health. By fostering innovative research and facilitating collaboration among scientists, healthcare professionals, and communities, NICHD plays a vital role in translating scientific discoveries into effective interventions and policies that enhance child health, reproductive health, and the prevention of diseases.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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