Fertilitetscentrum, Göteborg, Sweden.
Hum Reprod. 2012 Jan;27(1):89-96. doi: 10.1093/humrep/der373. Epub 2011 Nov 7.
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.
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.
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).
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.
ISRCTN23817363.
近红外（NIR）光谱学是一种旨在促进非侵入性筛选最适合子宫转移的人类胚胎的技术。有人提出，胚胎废弃培养液的 NIR 光谱特征可用于生成与植入潜力相关的活力评分。由于最初的原理验证研究都是回顾性的，我们的目的是研究在现场、前瞻性环境中对胚胎废弃培养液进行 NIR 光谱分析是否可以提高第 2 天和第 5 天转移后的单胚胎转移（SET）妊娠率。
我们进行了一项单中心、双盲、随机对照试验，将 NIR 组与对照组进行比较。主要结局是每个随机患者的 6-7 周妊娠后的临床妊娠率。在对照组中，胚胎选择仅基于传统的形态评估，而在治疗组中，NIR 光谱分析被添加到形态评估中。
该研究因数据分析安全监测委员会的分析显示主要结局的优越性的条件效力非常低而提前终止。在计算的 752 名患者中，164 名和 163 名患者分别被随机分配到 NIR 组和对照组。NIR 组和对照组随机患者的持续妊娠率无显著差异，分别为 34.8%和 35.6%（P=0.97）。研究组间平均差异的比例为-0.8%（95%置信区间-11.4 至 10.2）。
本研究表明，在进行 SET 时，以目前的形式将 NIR 光谱分析添加到胚胎形态学中并不能提高活产妊娠的机会。NIR 技术似乎需要进一步开发，才能作为胚胎活力的客观标志物。
ISRCTN23817363。
