title: A randomized clinical trial of endometrial perfusion with granulocyte colony-stimulating factor in in vitro fertilization cycles: impact on endometrial thickness and clinical pregnancy rates.
abstract: OBJECTIVE
  To investigate whether granulocyte colony-stimulating factor (G-CSG) affects endometrial thickness, implantation rates, and clinical pregnancy rates in routine, unselected IVF cycles.
  
  
  METHODS
  Registered, individually randomized, two-group, parallel double-blinded placebo-controlled clinical trial.
  
  
  METHODS
  Academically affiliated private clinical and research center.
  
  
  METHODS
  141 consecutive, unselected, consenting women with no history of renal disease, sickle cell disease, or malignancy who were undergoing IVF.
  
  
  METHODS
  Sealed, numbered, opaque envelopes assigned 73 patients to receive G-CSF (Filgrastim, Amgen, 300 μg/1.0 mL) and 68 to receive placebo (saline).
  
  
  METHODS
  Endometrial thickness, clinical pregnancy, and embryo implantation rates.
  
  
  RESULTS
  The mean age for the whole study group was 39.59 ± 5.56 years (G-CSF: 39.79 ± 5.13 years; placebo: 39.38 ± 6.03 years). Endometrial thickness statistically significantly increased over the 5-day observation period for the whole group by approximately 1.36 mm. The increase in the G-CSF group was not statistically significantly different from the control group. Statistical models looking at treatment effects on clinical pregnancy and implantation rates demonstrated no effect of G-CSF treatment. There were no adverse events for either treatment group.
  
  
  CONCLUSIONS
  In normal IVF patients, G-CSF does not affect endometrial thickness, implantation rates, or clinical pregnancy rates. Because these results were obtained in an older patient population, they may not necessarily apply to younger women.
  
  
  BACKGROUND
  NCT01202656.
authors.affiliation: The Center for Human Reproduction (CHR), New York, New York; Foundation for Reproductive Medicine, New York, New York. Electronic address: dbarad@thechr.com.
authors.forename: David H
authors.initials: DH
authors.lastname: Barad
authors.affiliation: The Center for Human Reproduction (CHR), New York, New York; Foundation for Reproductive Medicine, New York, New York.
authors.forename: Yao
authors.initials: Y
authors.lastname: Yu
authors.affiliation: The Center for Human Reproduction (CHR), New York, New York; Foundation for Reproductive Medicine, New York, New York.
authors.forename: Vitaly A
authors.initials: VA
authors.lastname: Kushnir
authors.affiliation: The Center for Human Reproduction (CHR), New York, New York; Foundation for Reproductive Medicine, New York, New York.
authors.forename: Aya
authors.initials: A
authors.lastname: Shohat-Tal
authors.affiliation: The Center for Human Reproduction (CHR), New York, New York; Foundation for Reproductive Medicine, New York, New York.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Lazzaroni
authors.affiliation: The Center for Human Reproduction (CHR), New York, New York; Foundation for Reproductive Medicine, New York, New York.
authors.forename: Ho-Joon
authors.initials: HJ
authors.lastname: Lee
authors.affiliation: The Center for Human Reproduction (CHR), New York, New York; Foundation for Reproductive Medicine, New York, New York.
authors.forename: Norbert
authors.initials: N
authors.lastname: Gleicher
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004717:Endometrium / Q000187:drug effects* / Q000473:pathology / Q000502:physiology; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods* / Q000639:trends; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D010477:Perfusion / Q000379:methods*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology; D018873:Pregnancy Rate / Q000639:trends
chemical_list: D016179:Granulocyte Colony-Stimulating Factor
keywords: Endometrial thickness; G-CSF; granulocyte colony-stimulating factor; in vitro fertilization; pregnancy rates; randomized controlled trial