Non-invasive metabolomic analysis using a commercial NIR instrument for embryo selection

Ioannis A Sfontouris, George T Lainas, Denny Sakkas, Ioannis Z Zorzovilis, George K Petsas, Trifon G Lainas, Ioannis A Sfontouris, George T Lainas, Denny Sakkas, Ioannis Z Zorzovilis, George K Petsas, Trifon G Lainas

Abstract

Context: Metabolomics was introduced in human in vitro fertilization (IVF) for noninvasive identification of viable embryos with the highest developmental competence.

Aims: To determine whether embryo selection using a commercial version of metabolomic analysis leads to increased implantation rates (IRs) with fetal cardiac activity (FCA) compared with morphology evaluation alone.

Setting and design: Randomized controlled trial from April to December 2010 at a private IVF unit. The study was terminated prematurely due to the market withdrawal of the instrument.

Materials and methods: IVF patients ≥18 and ≤43 years with ≥4 × 2PN were randomly allocated to metabolomic analysis combined with embryo morphology (ViaMetrics-E; metabolomics + morphology group) or embryo morphology alone (morphology group). Cycles with frozen embryos, oocyte donations, or testicular biopsy were excluded.

Statistical analysis: Categorical and continuous data were analyzed for statistical significance using 2-tailed Fisher's exact test and t-test, respectively. Statistical significance was accepted when P > 0.05.

Results: A total of 125 patients were included in the study; 39 patients were allocated to metabolomics + morphology group and 86 patients to morphology group. Patients were stratified according to the day of embryo transfer (Days 2, 3, or 5). IRs with FCA were similar for Days 2 and 3 transfers in both groups. For Day 5 transfers, IRs with FCA were significantly higher in the metabolomics + morphology group (46.8% vs. 28.9%; P = 0.041; 95% confidence intervalp [CI]: 1.09-34.18). Pregnancy and live births rates were similar for Days 2, 3, and 5 in both groups. The study was terminated early following the voluntary market withdrawal of ViaMetrics-E in December 2010.

Conclusions: Metabolomic analysis using the commercial near-infrared (NIR) instrument does not appear to have a beneficial effect on pregnancy and live births, with improvement in IR with FCA for Day 5 transfers. However, no solid conclusions can be reached due to the lack of adequate study power.ClinicalTrials.gov Identifier: NCT01490515.

Keywords: Embryo selection; implantation rates; metabolomics; near-infrared; noninvasive.

Conflict of interest statement

Conflict of Interest: None declared.

Figures

Figure 1
Figure 1
Consort diagram of study

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