NIH Clinical Research Studies

Protocol Number: 92-CH-0223

Active Accrual, Protocols Recruiting New Patients

Title:
Autoimmune Premature Ovarian Failure: A Controlled Trial of Alternate-Day Prednisone Therapy
Number:
92-CH-0223
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.

Sponsoring Institute:
National Institute of Child Health and Human Development (NICHD)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Female
Referral Letter Required: Yes
Population Exclusion(s): Male

Eligibility Criteria:
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.

Special Instructions: Currently Not Provided
Keywords:
Infertility
Ovulation
Autoimmune
Follicle
Menopause
Biopsy
Glucocorticoids
Recruitment Keywords:
Premature Ovarian Failure
Amenorrhea
Ovarian Failure
POF
Conditions:
Autoimmune Disease
Infertility
Premature Ovarian Failure
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Murine post-thymectomy autoimmune oophoritis develops in association with a persistent neonatal-like Th2 response

The use of human recombinant gonadotropin receptors to search for IgG mediated premature ovarian failure

Routine endocrine screening for patients with karyotypically normal spontaneous premature ovarian failure

Active Accrual, Protocols Recruiting New Patients

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