The Effects of Intravenous Immunoglobulins in XXXX with Recurrent Miscarriages: A Systematic Review of Randomised Trials with Meta-Analyses and Trial Sequential Analyses Including Individual @entity1 Data.

@entity1 @entity7992
BACKGROUND: Immunological disturbances are hypothesised to play a role in @entity7992 ( @entity7992 ) and therefore intravenous immunoglubulins (IVIg) have been tested in @entity7992 @entity1 . OBJECTIVES: The objectives were to investigate the benefits and harms of IVIg versus placebo, no intervention, or treatment as usual in @entity1 with @entity7992 . SEARCH STRATEGY: We searched the published literature in all relevant databases. SELECTION CRITERIA: Randomised trials investigating IVIg versus placebo, no intervention, or treatment as usual in @entity1 with @entity7992 . DATA COLLECTION AND ANALYSIS: We undertook meta-analyses of aggregated data and individual @entity1 data using a two-step approach, and we conducted bias domain assessments and trial sequential analyses to assess the risks of systematic and random errors. MAIN RESULTS: We identified 11 randomised clinical trials. No significant difference in the frequency of no live birth was found when IVIg was compared with placebo or treatment as usual (RR 0.92, 95% CI 0.75-1.12, p = 0.42). Trial sequential analysis showed that the required information size of 1,008 @entity1 was not obtained. IVIg compared with placebo seems to increase the risk of adverse events. Subgroup analysis suggests that @entity1 with @entity7992 after a birth (secondary @entity7992 ) seemed most likely to obtain a potential beneficial effect of IVIg (RR for no live birth 0.77, 95%CI 0.58-1.02, p = 0.06), however, trial sequential analysis showed that insufficient information is presently accrued. CONCLUSION: We cannot recommend or refute IVIg in @entity1 with @entity7992 . IVIg should therefore be assessed in further randomised clinical trials with positive outcomes before any clinical use is considered.
