National Institute of Health Clinical Research Study Summary: 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 necrosisof 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 one patient 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.
Sponsoring Institute: National Institute of Child Health and Human Development (NICHD)
Recruitment Detail:
Type: Active Accrual Of New Subjects
Gender: Female
For questions about participating in a study, please contact the Patient Recruitment and Referral Service, CC. Quarters 15D-2, 4 West Drive MSC2655 Bethesda, MD 20892-2655 Local Calls: 301/496-4891 Long Distance Calls: 800/411-1222 Fax: 301/480-9793 EMail: :prrc@cc.nih.gov
