title: A randomized clinical trial to evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium for in vitro fertilization.
abstract: OBJECTIVE
  To evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium on ongoing implantation rate (OIR).
  
  
  METHODS
  Multicenter, randomized, placebo-controlled, double-blinded prospective design.
  
  
  METHODS
  Fourteen Scandinavian fertility clinics.
  
  
  METHODS
  A total of 1,332 women with indication for in vitro fertilization or intracytoplasmic sperm injection; 1,149 received embryo transfer (GM-CSF: n = 564; control: n = 585).
  
  
  METHODS
  Oocytes were fertilized, and embryos cultured and transferred in control medium or test medium containing 2 ng/mL GM-CSF.
  
  
  METHODS
  OIR at gestational week 7, with follow-up at week 12 and birth.
  
  
  RESULTS
  At week 7, OIRs were 23.5% (GM-CSF), and 20.0% (control) (odds ratio [OR] 1.26, 95% confidence interval [CI] 0.91-1.75). At week 12, OIRs were 23.0% (GM-CSF) and 18.7% (control) (OR 1.35, 95% CI 1.06-1.72), and live birth rates were 28.9% and 24.1%, respectively (OR 1.35, 95% CI 1.03-1.78). The effect of GM-CSF was influenced by the human serum albumin concentration in the medium. Birth weight and abnormality incidence were similar in both groups. Exploratory analyses showed that GM-CSF increased OIR in women with previous miscarriage, especially in women with more than one miscarriage.
  
  
  CONCLUSIONS
  Addition of GM-CSF to embryo culture medium elicits a significant increase in survival of transferred embryos to week 12 and live birth. Our results are consistent with a protective effect of GM-CSF on culture-induced embryo stress. GM-CSF may be particularly efficacious in women with previous miscarriage.
  
  
  BACKGROUND
  NCT00565747.
authors: Fertility Clinic, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark. soeren.ziebe@rh.regionh.dk
authors: Søren
authors: S
authors: Ziebe
authors: Anne
authors: A
authors: Loft
authors: Betina B
authors: BB
authors: Povlsen
authors: Karin
authors: K
authors: Erb
authors: Inge
authors: I
authors: Agerholm
authors: Michael
authors: M
authors: Aasted
authors: Anette
authors: A
authors: Gabrielsen
authors: Christina
authors: C
authors: Hnida
authors: Dorit P
authors: DP
authors: Zobel
authors: Bibi
authors: B
authors: Munding
authors: Susanne H
authors: SH
authors: Bendz
authors: Sarah A
authors: SA
authors: Robertson
mesh_terms: D000328:Adult; D015331:Cohort Studies; D004311:Double-Blind Method; D046149:Embryo Culture Techniques / Q000379:methods*; D010064:Embryo Implantation / Q000502:physiology; D004624:Embryo Transfer / Q000379:methods; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D005500:Follow-Up Studies; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D007231:Infant, Newborn; D050498:Live Birth / Q000453:epidemiology; D011247:Pregnancy; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D016178:Granulocyte-Macrophage Colony-Stimulating Factor