Placebo-controlled trial of treatment of unexplained secondary recurrent spontaneous abortions and recurrent late spontaneous abortions with i.v. immunoglobulin

Abstract

The aim of this trial was to investigate whether infusions of i.v. immunoglobulins (Ig) to women with secondary recurrent spontaneous abortions and recurrent second trimester spontaneous abortions can increase the rate of successful pregnancy. In a prospective, double-blind, placebo-controlled trial, infusions of i.v. Ig (Nordimmun) or placebo were given during pregnancy to 34 women with a history of either unexplained recurrent spontaneous abortion subsequent to a birth or including at least one second trimester miscarriage. The success rate was 52.9% in the i.v. Ig group compared with 29.4% in the placebo group (not significantly different, therapeutic gain 23.5%, 95% confidence interval -8.6 to 55.7%). No changes in autoantibody concentrations or major lymphocyte subsets were induced by i.v. Ig treatment. In conclusion, an expected 55% therapeutic gain of i.v. Ig in recurrent spontaneous abortion could not be confirmed using the treatment regimen tested. However, to determine whether the trend of therapeutic gain of i.v. Ig in these women may be statistically significant, a larger trial is in progress.

Is intravenous immunoglobulins (IVIG) efficacious in early pregnancy failure? A critical review and meta-analysis for patients who fail in vitro fertilization and embryo transfer (IVF)

“…Moffet et al (31) also argued that assays of the cytotoxic activity of blood NK cells in vitro had no Table II Negative Stephenson [39] (51) Stephenson [51] (4) German Grp [64] (52) None Christiansen [34] (53) Christiansen [58] (54) Perino [46] (55) Jablonowska [41] (56) meaning as the function of uterine NK cells in vivo was mediated by the cytokines they produce and not by cytotoxicity. However, there are many types of in vitro assays that do not measure functionally relevant activity in vivo.…”

Advances of intravenous immunoglobulin G in modulation of anti-fetal immunity in selected at-risk populations: science and therapeutics

“…In another study, the prevalence of a 14 base pair insertion in exon 8 of the HLA-G gene was found to be increased significantly in secondary RM patients, compared with controls. These studies provide evidence that particular HLA polymorphisms characterize secondary RM [5][6][7].Huge heterogeneity between eight randomized placebocontrolled trials of IVIg to patients with RM has been observed, with live birth rates in placebo groups ranging from 29 to 79% [8][9][10][11][12][13][14][15]. The differences in live birth rates observed between these studies raises questions as to whether the patient categories are the same.…”

“…Huge heterogeneity between eight randomized placebocontrolled trials of IVIg to patients with RM has been observed, with live birth rates in placebo groups ranging from 29 to 79% [8][9][10][11][12][13][14][15]. The differences in live birth rates observed between these studies raises questions as to whether the patient categories are the same.…”

Effect of IgG Therapy on Lymphocyte Subpopulations in the Peripheral Blood of Kuwaiti Women Experiencing Recurrent Pregnancy Loss

“…The clinical guidelines on RPL stated by the Royal College of Obstetricians and Gynecologists [10], for example, have indicated lack of strong evidence for the use of immunotherapy. This conclusion was mainly drawn by Daya et al [11] and from the meta-analysis of six studies performed by the German RSA/IVIG Group [12], Christiansen et al [13], Stephenson et al [14], Perino et al [15], Coulam et al [16] and Kipron et al [17]. Five European pilot studies with a total of 172 patients as well as one controlled double-blind multicenter study including 64 patients were considered; using albumin as a placebo, a similar conclusion was drawn, i.e.…”