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Home > "S" Clinical Trials Conditions > Steroid Therapy in Autoimmune Premature Ovarian Failure  Steroid Therapy in Autoimmune Premature Ovarian Failure
Steroid Therapy in Autoimmune Premature Ovarian Failure
For Condition: Autoimmune Disease,Infertility,Premature Ovarian Failure
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: No therapy for infertile patients with premature ovarian failure 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 autoimmune ovarian failure. The protocol will use a double-masked, placebo-controlled design. Patients will undergo ovarian biopsy by laparoscopy to confirm the presence of autoimmune oophoritis. Ovarian biopsy carries a mortality risk approximately equivalent to the risk women accept when they decide to undergo surgical sterilization. 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION 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. EXCLUSION CRITERIA: No evidence for genetic, metabolic, toxic, or iatrogenic cause of the ovarian failure, No medical contraindication to glucocorticoid therapy, No glucocorticoid therapy taken in the past year (patients on appropriate replacement therapy for Addison's disease are not excluded), No medical contraindication to surgery or pregnancy.
Total Enrollment: 50
Location and Contact Information:
National Institute of Child Health and Human Development (NICHD) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 920223; 92-CH-0223
Study Start Date: July 10, 1992
Record last reviewed: May 14, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001306
Other Infertility Studies:
1. Steroid Therapy in Autoimmune Premature Ovarian Failure
2. Pyrimethamine and Sulfadoxine for Treatment of Autoimmune Lymphoproliferative Syndrome
3. Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Children
4. Study of Autoimmune Lymphoproliferative Syndrome (ALPS)
5. Study and Treatment of Inflammatory Muscle Diseases
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Steroid Therapy in Autoimmune Premature Ovarian Failure
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