A randomized clinical trial to evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium for in vitro fertilization

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dc.contributor.authorZiebe, S.
dc.contributor.authorLoft, A.
dc.contributor.authorPovlsen, B.
dc.contributor.authorErb, K.
dc.contributor.authorAgerholm, I.
dc.contributor.authorAasted, M.
dc.contributor.authorGabrielsen, A.
dc.contributor.authorHnida, C.
dc.contributor.authorZobel, D.
dc.contributor.authorMunding, B.
dc.contributor.authorBendz, S.
dc.contributor.authorRobertson, S.
dc.date.issued2013
dc.description.abstract<h4>Objective</h4>To evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium on ongoing implantation rate (OIR).<h4>Design</h4>Multicenter, randomized, placebo-controlled, double-blinded prospective design.<h4>Setting</h4>Fourteen Scandinavian fertility clinics.<h4>Patient(s)</h4>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).<h4>Intervention(s)</h4>Oocytes were fertilized, and embryos cultured and transferred in control medium or test medium containing 2 ng/mL GM-CSF.<h4>Main outcome measure(s)</h4>OIR at gestational week 7, with follow-up at week 12 and birth.<h4>Result(s)</h4>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.<h4>Conclusion(s)</h4>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.<h4>Clinical trial registration number</h4>NCT00565747.
dc.description.statementofresponsibilitySøren Ziebe, Anne Loft, Betina B. Povlsen, Karin Erb, Inge Agerholm, Michael Aasted, Anette Gabrielsen, Christina Hnida, Dorit P. Zobel, Bibi Munding, Susanne H. Bendz and Sarah A. Robertson
dc.identifier.citationFertility and Sterility, 2013; 99(6):1600-1609
dc.identifier.doi10.1016/j.fertnstert.2012.12.043
dc.identifier.issn0015-0282
dc.identifier.issn1556-5653
dc.identifier.orcidRobertson, S. [0000-0002-9967-0084]
dc.identifier.urihttp://hdl.handle.net/2440/80451
dc.language.isoen
dc.publisherElsevier Science Inc
dc.rightsCopyright © 2013 American Society for Reproductive Medicine
dc.source.urihttps://doi.org/10.1016/j.fertnstert.2012.12.043
dc.subjectEmbryo development
dc.subjectGM-CSF
dc.subjectin vitro fertilization
dc.subjectmiscarriage
dc.subjectperinatal outcome
dc.titleA randomized clinical trial to evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium for in vitro fertilization
dc.typeJournal article
pubs.publication-statusPublished

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