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Steroid Therapy in Autoimmune Premature Ovarian Failure

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clinicaltrials.gov/study/NCT00001306
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT000013060
Health Conditions in Trial
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Infertility
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Autoimmune disease
Autoimmune disease
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Premature ovarian failure
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Clinical Trial Start Date
July 10, 1992
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Study Completion Date
December 12, 2011
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Official Name
Autoimmune Premature Ovarian Failure: A Controlled Trial of Alternate-Day Prednisone Therapy0
Last Updated
July 2, 2017
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Study 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 in treating autoimmune ovarian failure. However, prednisone, when used in high-doses for long periods of time has substantial side effects, including aseptic necrosis of bone where portions of bone die without the presence of infection and are surrounded by healthy tissue. Aseptic necrosis of bone often requires major surgical treatment. Even with this known level of risk, patients with premature ovarian failure are being treated based on this anecdotal evidence. This study will test the hypothesis that a lower risk therapy (alternate-day, lower dose, shorter-term prednisone) will cause a remission of autoimmune ovarian failure. There is no reliable blood test to identify patients who have premature ovarian failure. Therefore, all patients must undergo a laparoscopic ovarian biopsy to confirm the presence of an auto immune reaction in the ovaries (autoimmune oophoritis). Laparoscopy is a surgical procedure that allows doctors to explore the abdomen using a camera-like device called a laparoscope. The procedure has been used clinically by some reproductive endocrinologists to identify patients with premature ovarian failure who have an autoimmune mechanism for the disorder. The treatment will be deemed successful based on the return of ovulation as determined by weekly serum progesterone levels.

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