The Fertility Clinic, Braedstrup Hospital, Sygehusvej 20, Braedstrup, Denmark.
Reprod Biomed Online. 2010 Apr;20(4):477-84. doi: 10.1016/j.rbmo.2009.12.026. Epub 2009 Dec 28.
The effect on ploidy rate in donated human oocytes after in-vitro culture with recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF; 2 ng/ml) from fertilization until day 3 was examined in a multicentre, prospective placebo-controlled and double-blinded study including 73 women donating 86 oocytes. The primary endpoint was to investigate the chromosomal constitution of human embryos (fluorescence in-situ hybridization analysis for chromosomes 13, 16, 18, 21, 22, X and Y) cultured with or without GM-CSF. The secondary endpoints were number of top-quality embryos (TQE) and number of normally developed embryos evaluated morphologically on day 3. The cytogenetic analyses demonstrated non-inferiority and therefore the chromosomal constitution of human embryos cultured in vitro in the presence of 2 ng/ml GM-CSF was no worse than the control group cultured without GM-CSF. In-vitro culture of human embryos in the presence of 2 ng/ml GM-CSF resulted in 34.8% (8/23) uniformly normal embryos. Culture without 2 ng/ml GM-CSF resulted in 33.3% (9/27) uniformly normal embryos. A trend towards a higher number of TQE in the test group was observed; however, due to lack of TQE in the control group, this was considered a random finding.
在一项多中心、前瞻性、安慰剂对照、双盲研究中,检查了在体外受精后用重组人粒细胞-巨噬细胞集落刺激因子(GM-CSF;2ng/ml)培养至第 3 天对捐赠人类卵子的二倍体率的影响,该研究纳入了 73 名捐赠 86 个卵子的女性。主要终点是研究培养有或没有 GM-CSF 的人类胚胎的染色体组成(用荧光原位杂交分析染色体 13、16、18、21、22、X 和 Y)。次要终点是优质胚胎(TQE)的数量和第 3 天形态学评估的正常发育胚胎的数量。细胞遗传学分析表明非劣效性,因此在存在 2ng/ml GM-CSF 的情况下体外培养的人类胚胎的染色体组成并不比未培养 GM-CSF 的对照组差。在存在 2ng/ml GM-CSF 的情况下体外培养人类胚胎导致 34.8%(8/23)的胚胎均匀正常。没有 2ng/ml GM-CSF 的培养导致 33.3%(9/27)的胚胎均匀正常。观察到实验组 TQE 数量有增加的趋势;然而,由于对照组缺乏 TQE,这被认为是一个随机发现。