Steroid Therapy in Autoimmune Premature Ovarian Failure

NCT00001306 | Completed

• 2 other identifiers: 92022392-CH-0223
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Disease; Infertility; Premature Ovarian Failure

Keywords

Infertility; Ovulation; Autoimmune; Follicle; Menopause; Biopsy; Glucocorticoids; Premature Ovarian Failure; Amenorrhea; Ovarian Failure; POF

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Maity R, Caspi RR, Nair S, Rizzo LV, Nelson LM. Murine postthymectomy autoimmune oophoritis develops in association with a persistent neonatal-like Th2 response. Clin Immunol Immunopathol. 1997 Jun;83(3):230-6. doi: 10.1006/clin.1997.4338.

  PMID: 9175911 BACKGROUND

• Anasti JN, Flack MR, Froehlich J, Nelson LM. The use of human recombinant gonadotropin receptors to search for immunoglobulin G-mediated premature ovarian failure. J Clin Endocrinol Metab. 1995 Mar;80(3):824-8. doi: 10.1210/jcem.80.3.7883837.

  PMID: 7883837 BACKGROUND

• Kim TJ, Anasti JN, Flack MR, Kimzey LM, Defensor RA, Nelson LM. Routine endocrine screening for patients with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1997 May;89(5 Pt 1):777-9. doi: 10.1016/s0029-7844(97)00077-x.

  PMID: 9166320 BACKGROUND

MeSH Terms

Conditions

Autoimmune Diseases; Infertility; Primary Ovarian Insufficiency; Amenorrhea

Condition Hierarchy (Ancestors)

Immune System Diseases; Genital Diseases; Urogenital Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: July 10, 1992
• Study Completion: December 12, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-12-12

Locations

US (1)