Effectiveness of Intravenous Immunoglobulin (IVIG) Therapy in Treatment of Recurrent Pregnancy Loss or Miscarriage
Recurrent pregnancy loss or miscarriage is often a sign of an underlying fertility problem. Depending on the cause of frequent miscarriages, fertility treatment may improve your chances of conceiving after a miscarriage & to help you maintain a positive and successful pregnancy to term.
Intravenous immunoglobulin (IVIG) is a treatment option for those who experience recurrent pregnancy loss due to autoimmune problems. It happens when your body's immune system becomes hostile to the embryo or fetus, mistaking it for a foreign body . There are many studies suggesting why IVIG therapy may work, but the exact mechanism of action is not entirely clear. It is thought that by receiving immunoglobulins in the form of a transfusion, the amount of natural killer (NK) cells in the woman's body are reduced, and/or antibodies that cause the body to attack the pregnancy might be absorbed or blocked. Thus, a woman's immune system is repressed to possibly allow embryos to implant following embryo transfer.
How often do you have to take IVIG during pregnancy?
The dosage and timing of the therapy varies by what is being treated. For those patients that are having in vitro fertilization (IVF) and have issues with NK cells and/or other harmful antibody related issues, the IVIG is usually given 10 days before the IVF procedure. IVIG is repeated once again after the pregnancy is confirmed. For those patients attempting natural impregnation that have NK cell and/or other harmful antibody related issues, the IVIG is usually dosed before the before the natural impregnation is attempted, then repeated again after pregnancy is confirmed. After this, most centers give further repeated doses throughout the pregnancy, but the frequency of these doses varies widely from center to center.
Are there any harmful effects of IVIG on unborn baby?
According to FDA, IVIG falls under Pregnancy Category C which means that it is not known whether immune globulin will harm an unborn baby. The FDA Pregnancy Cetegory C states that "Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks". One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of data on a pharmaceutical for it to be defined as pregnancy category A or even Category B. Additionally, since IVIG is not FDA approved for the treatment of recurrent pregnancy loss and that there is the likelihood of significant legal cases that could result from any widespread study of IVIG impact on newborns when the IVIG was used for infertility in the mother all lead to the current state of IVIG being listed as a category C, which is where most drugs end up if there is not an exceptional amount of data to move them to Categories A or B.
Does health insurance pay for IVIG therapy for recurrent pregnancy loss?
Since there is not enough clinical data to show effectiveness of IVIG treatment in prevention of recurrent pregnancy loss, most insurance companies consider IVIG therapy as experimental and investigational and therefore do not cover the cost of the IVIG nor the nursing visits needed to infuse the drug. For those patients wishing to pay cash for the IVIG therapy for infertility therapy in the home, the costs can range from $5,000 to $20,000 per one course of treatment (i.e., 35 grams of IVIG given at home daily for 5 days in a row might cost $17,000 with Drug, Nursing and IV supplies).
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