Trial Information

Summary: Intravenous Immunoglobulin for Secondary Recurrent Miscarriage: A Randomized Controlled Trial

Closed to enrolling new subjects

This trial is supported by the University of Chicago’s National Institute of Health (NIH) General Clinical Research Center (GCRC).

Study Summary
Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are trying to establish a family. The University of Chicago and Dr. Mary Stephenson are conducting a clinical study to evaluate the effectiveness of intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from secondary recurrent miscarriage. IVIG is not a new medication, it is used for many immune disorders. While IVIG has not received approval for use in treating recurrent miscarriage, recent evidence suggests it may be helpful in improving the mother’s immune response to pregnancy. This study will help in providing an answer to the question of whether IVIG is helpful in secondary recurrent miscarriage.

Participants will be assigned by chance to receive either intravenous IVIG or salt water (an inactive substance). The intravenous (IV) solutions are given once monthly during the first half of the menstrual cycle until pregnancy is achieved, and then every 4 weeks until 5 months of pregnancy. If pregnancy does not occur within 6 cycles, participation in the study will stop. Each IV solution requires up to 6 hours to administer. Participants will also be asked to return weekly for blood draws 3 times during the study.

Dr. Stephenson and her research staff will monitor the pregnancy closely during the first trimester. The patient will then be transferred back to the referring physician for the remainder of the pregnancy.

There will be no charge for the study-related procedures, study-related care or study drug. The cost of routine care prior to and during pregnancy will be the participant’s responsibility. The study procedures and study follow-up will all be performed at the University of Chicago Hospitals.

The benefits of participating in this trial include the possibility of improving the chance of having a successful pregnancy. In addition, participants would contribute to the advancement of recurrent miscarriage research, in particular with respect to some important questions about the maternal immune responses to pregnancy.

Participation Details
Initial selection criteria for the study include:

• Women between 18 and 44 years of age
• History of a successful pregnancy followed by at least three miscarriages, all conceived with the same partner.
• Genetic, endocrine, anatomical and autoimmune factors associated with recurrent miscarriage have been ruled out.

Study Director: Mary D. Stephenson, MD, MSc
Department: Obstetrics and Gynecology

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Trial listings updated: November 7, 2008 at 3:17:35 PM