Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001306
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Steroid Therapy in Autoimmune Premature Ovarian Failure
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Autoimmune Premature Ovarian Failure A Controlled Trial of Alternate-Day Prednisone Therapy
Status:
COMPLETED
Status Verified Date:
2011-12-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 92-CH-0223 | None | None | None |