Non-invasive metabolomic profiling of Day 2 and 5 embryo culture medium: a prospective randomized trial
Non-invasive metabolomic profiling of Day 2 and 5 embryo culture medium: a prospective randomized trial
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DOI：
10.1093/humrep/der373
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发表时间：
2012-01-01
影响因子：
6.1
通讯作者：
Wikland, M.
中科院分区：
文献类型：
--
作者：
Hardarson, T.;Ahlstrom, A.;Wikland, M.
背景：近红外（NIR）光谱是一项旨在促进非侵入性筛选最适合子宫移植的人类胚胎的技术。有人提出，胚胎用过的培养基的近红外光谱图可用于生成与植入潜力相关的活力评分。由于最初的原理证明研究都是回顾性的，我们的目的是调查在现场、前瞻性环境中对废胚胎培养基进行近红外光谱分析是否可以提高第 2 天和第 5 天移植后正在进行的单胚胎移植 (SET) 妊娠率。 方法：我们进行了一项单中心、双盲、随机对照试验，其中将近红外组与对照组进行了比较。主要结局是每位随机患者妊娠 6-7 周后的临床妊娠率。在对照组中，胚胎选择仅基于传统的形态学评估，而在治疗组中，近红外光谱法被添加到形态学评估中。 结果：由于数据安全监测委员会的分析显示主要结果的条件优越性非常低，因此该研究提前终止。在计算纳入该研究的 752 名患者中，分别有 164 名和 163 名患者被随机分为 NIR 组和对照组。 NIR 组和对照组之间每位随机患者的持续妊娠率没有显着差异，分别为 34.8% 和 35.6%（P = 0.97）。研究组平均值之间的比例差异为 -0.8%（95% 置信区间为 -11.4 至 10.2）。 结论：这项研究表明，在胚胎形态学中添加目前形式的近红外光谱并不会提高进行 SET 时可行妊娠的机会。近红外技术似乎需要进一步发展才能用作胚胎活力的客观标记。
BACKGROUND: Near infrared (NIR) spectroscopy is a technology proposed to facilitate non-invasive screening for the most optimal human embryo for uterine transfer. It has been proposed that the NIR spectral profile of an embryo's spent culture medium can be used to generate a viability score that correlates to implantation potential. As the initial proof of principle studies were all retrospective, our aim was to investigate whether NIR spectroscopy on spent embryo culture medium in an on-site, prospective setting could improve the ongoing single embryo transfer (SET) pregnancy rate after Day 2 and 5 transfers.METHODS: We conducted a single-centre, double-blinded, randomized controlled trial in which the NIR group was compared with a control group. The primary outcome was the clinical pregnancy rate after 6-7 weeks of gestation per randomized patient. In the control group embryo selection was based only on traditional morphological evaluation while in the treatment group NIR spectroscopy was added to the morphological evaluation.RESULTS: The study was terminated early as the analysis of the Data Safety Monitoring Board showed a very low conditional power of superiority for the primary outcome. Of the 752 patients calculated to be included in the study, 164 and 163 patients were randomized into the NIR and control groups, respectively. No significant difference in the ongoing pregnancy rate per randomized patient was found between the NIR and the control group, 34.8 versus 35.6%, (P = 0.97). The proportional difference between the study groups mean was -0.8% (95% confidence interval -11.4 to 10.2).CONCLUSIONS: This study shows that adding NIR spectroscopy, in its present form, to embryo morphology does not improve the chance of a viable pregnancy when performing SET. The NIR technology appears to need further development before it can be used as an objective marker of embryo viability.