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NCT00001306 · ClinicalTrials.gov registry record

Steroid Therapy in Autoimmune Premature Ovarian Failure

A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
33
Enrollment target

NCT00001306 is a clinical trial that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 33 participants.

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The verdict

NCT00001306 has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
33 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 1992-07-10
Est. Completion 2011-12-12

What the Registry Record Tells You About NCT00001306

The ClinicalTrials.gov registry entry for NCT00001306 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00001306 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00001306 about?

NCT00001306 is a clinical study titled "Steroid Therapy in Autoimmune Premature Ovarian Failure". 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...

What is the current status of trial NCT00001306?

This trial is currently completed. The enrollment target is 33 participants. The study started on 1992-07-10. Estimated completion is 2011-12-12.

Who is sponsoring clinical trial NCT00001306?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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