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Human Reproduction, Vol. 17, No. 3, 809-816, March 2002
© 2002 European Society of Human Reproduction and Embryology

A randomized, double-blind, placebo-controlled trial of intravenous immunoglobulin in the prevention of recurrent miscarriage: evidence for a therapeutic effect in women with secondary recurrent miscarriage

Ole B. Christiansen1,3,4, Bjørn Pedersen2, Anni Rosgaard2 and Merete Husth2

1 Department of Clinical Immunology and 2 Department of Obstetrics and Gynaecology, Aalborg Hospital, Aalborg, Denmark and 3 Fertility Clinic 4071, Rigshospitalet, Copenhagen University Hospital, Denmark

BACKGROUND: Previous trials of intravenous immunoglobulin (IvIg) treatment of women with recurrent miscarriage (RM) have provided diverging results. This may be due to different inclusion criteria and suboptimal treatment protocols in some trials. METHODS: According to a computer-generated list, 58 women with at least four unexplained miscarriages were randomly assigned to receive infusions of high doses of IvIg or placebo starting as soon as the pregnancy test was positive. RESULTS: In the intention-to-treat analysis, a 45% live birth rate was found in both allocation groups. In patients with secondary RM, 50% in the treatment group and 23% in the placebo group had successful pregnancies (P = not significant). When data from the present and a previous placebo-controlled trial of the same treatment were combined, 15/26 (58%) of the patients with secondary RM in the treatment group versus 6/26 (24%) in the placebo group had successful outcomes (P < 0.02). Only 7% of the karyotyped abortuses were abnormal. CONCLUSIONS: IvIg may improve pregnancy outcome in patients with secondary RM. A new placebo-controlled trial focusing on this subgroup should be conducted to confirm the results.

Key words: abortion/HLA-DR/HY antigen/intravenous immunoglobulin/recurrent spontaneous abortion

4 To whom correspondence should be addressed at: Fertility Clinic 4071, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark. E-mail: obchr{at}post5.tele.dk

Submitted on August 13, 2001


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