title: Intravenous immunoglobulin treatment for secondary recurrent miscarriage: a randomised, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To determine whether infusions with intravenous immunoglobulin (IVIg) during early pregnancy increase live birth rate in women with secondary recurrent miscarriage compared with placebo.
  
  
  METHODS
  A single-centre, randomised, double-blind, placebo-controlled trial.
  
  
  METHODS
  A tertiary centre for recurrent miscarriage in Copenhagen, Denmark.
  
  
  METHODS
  A group of 82 women with unexplained secondary recurrent miscarriage and at least four miscarriages.
  
  
  METHODS
  Women were randomly assigned to repeated infusions with IVIg or placebo (albumin) from the time of positive pregnancy test to gestational week 15 or pregnancy loss.
  
  
  METHODS
  Primary outcome was birth with neonatal survival in all randomised women.
  
  
  RESULTS
  In the intention-to-treat analyses, live birth rates were 23/42 (54.8%) in the IVIg and 20/40 (50.0%) in the placebo group, relative risk 1.11 (95% CI 0.70-1.74). In a per protocol analysis, almost identical results were found. The median gestational length at delivery was higher in the IVIg than the placebo group (282 versus 272 days, P = 0.02) but the mean birthweight was not significantly increased.
  
  
  CONCLUSIONS
  In this trial, which is the largest so far, IVIg did not increase the live birth rate in patients with secondary recurrent miscarriage and the treatment cannot be recommended in clinical practice.
authors.affiliation: Fertility Clinic 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Obstetrics and Gynaecology, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: O B
authors.initials: OB
authors.lastname: Christiansen
authors.forename: E C
authors.initials: EC
authors.lastname: Larsen
authors.forename: P
authors.initials: P
authors.lastname: Egerup
authors.forename: L
authors.initials: L
authors.lastname: Lunoee
authors.forename: L
authors.initials: L
authors.lastname: Egestad
authors.forename: H S
authors.initials: HS
authors.lastname: Nielsen
mesh_terms: D000026:Abortion, Habitual / Q000453:epidemiology / Q000517:prevention & control*; D000328:Adult; D001723:Birth Rate; D001724:Birth Weight; D003718:Denmark / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage*; D007155:Immunologic Factors / Q000008:administration & dosage*; D007231:Infant, Newborn; D011247:Pregnancy; D017211:Treatment Failure
chemical_list: D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors
keywords: Immunotherapy; intravenous immunoglobulin; miscarriage; randomised controlled trial; recurrent miscarriage