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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• 作者：Sø ; ren Ziebe ; M.Sc. ; D.Sc.^a ; ^{soeren.ziebe@rh.regionh.dk} ; Anne Loft ; M.D.^a ; Betina B. Povlsen ; M.Sc.^b ; Karin Erb ; M.Sc.^c ; Inge Agerholm ; Ph.D.^d ; Michael Aasted ; M.D.^e ; Anette Gabrielsen ; M.Sc.^f ; Christina Hnida ; Ph.D.^g ; Dorit P. Zobel ; Ph.D.^h ; Bibi Munding ; M.Sc.^h ; Susanne H. Bendz ; Ph.D.^h ; Sarah A. Robertson ; Ph.D.ⁱ
• 关键词：Embryo development ; GM-CSF ; in vitro fertilization ; miscarriage ; perinatal outcome
• 刊名：Fertility and Sterility
• 出版年：2013
• 出版时间：May, 2013
• 年：2013
• 卷：99
• 期：6
• 页码：1600-1609.e2
• 全文大小：383 K

文摘

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Objective

To evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium on ongoing implantation rate (OIR).

Design

Multicenter, randomized, placebo-controlled, double-blinded prospective design.

Setting

Fourteen Scandinavian fertility clinics.

Patient(s)

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).

Intervention(s)

Oocytes were fertilized, and embryos cultured and transferred in control medium or test medium containing 2 ng/mL GM-CSF.

Main Outcome Measure(s)

OIR at gestational week 7, with follow-up at week 12 and birth.

Result(s)

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.

Conclusion(s)

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.

Clinical Trial Registration Number

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