Steroid Therapy in Autoimmune Premature Ovarian Failure
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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 surgical intervention. Despite this risk, patients with premature ovarian failure are being treated based on this anecdotal evidence. We are aware of two patients with premature ovarian failure who developed aseptic necrosis of bone on high-dose, long-term prednisone therapy administered elsewhere.
This protocol will test the hypothesis that a lower risk therapy (alternate-day, lower dose, shorter-term prednisone) will induce remission of ovarian failure caused by autoimmune oophoritis. The protocol will use a double-masked, placebo-controlled design. Patients with premature ovarian failure who have serologic evidence of steroidogenic cell autoimmunity will be candidates. Successful outcome will be defined as a return of ovulation as determined by weekly serum progesterone levels. The hypothesis that short-term, alternate-day prednisone therapy restores ovulation will be tested with an equality of proportions test comparing the proportion of patients who ovulate during placebo with the proportion of patients who ovulate during prednisone therapy.
Tarixlər
Son Doğrulandı: | 12/11/2011 |
İlk təqdim: | 11/02/1999 |
Təxmini qeydiyyat təqdim edildi: | 11/02/1999 |
İlk Göndərmə: | 11/03/1999 |
Son Yeniləmə Göndərildi: | 06/29/2017 |
Son Yeniləmə Göndərildi: | 07/01/2017 |
Həqiqi Təhsilin Başlama Tarixi: | 07/09/1992 |
Təxmini İşin Tamamlanma Tarixi: | 12/11/2011 |
Vəziyyət və ya xəstəlik
Faza
Uyğunluq Kriteriyaları
Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
Təhsilə Uyğun Cinslər | Female |
Sağlam Könüllüləri qəbul edir | Bəli |
Kriteriyalar | - 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. |