Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope

An alternative strategy for embryo selection based on a multivariable morphokinetic model combined with continuous incubation in an integrated timelapse monitoring system improves the clinical results.

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Authors

Irene Rubio, Ph.D., Arancha Galan, Ph.D., Zaloa Larreategui, Ph.D., Jose Bellver, M.D., Fernando Ayerdi, Ph.D., Javier Herrero, Ph.D., Marcos Meseguer, Ph.D.

Volume 102, Issue 5, Pages 1287-1294

Abstract

Objective:

To determine whether incubation in the integrated EmbryoScope time-lapse monitoring system (TMS) and selection supported by the use of a multivariable morphokinetic model improve reproductive outcomes in comparison with incubation in a standard incubator (SI) embryo culture and selection based exclusively on morphology.

Design:

Prospective, randomized, double-blinded, controlled study.

Setting:

University-affiliated private in vitro fertilization (IVF) setting.

Patient(s):

843 infertile couples undergoing intracytoplasmic sperm injection (ICSI).

Intervention(s):

No patient intervention; embryos cultured in SI with development evaluated only by morphology (control group) and embryos cultured in TMS with embryo selection was based on a multivariable model (study group).

Main Outcome Measure(s):

Rates of embryo implantation, pregnancy, ongoing pregnancy (OPR), and early pregnancy loss.

Result(s):

Analyzing per treated cycle, the ongoing pregnancy rate was statistically significantly increased 51.4% (95% CI, 46.7–56.0) for the TMS group compared with 41.7% (95% CI, 36.9–46.5) for the SI group. For pregnancy rate, differences were not statistically significant at 61.6% (95% CI, 56.9–66.0) versus 56.3% (95% CI, 51.4–61.0). The results per transfer were similar: statistically significant differences in ongoing pregnancy rate of 54.5% (95% CI, 49.6–59.2) versus 45.3% (95% CI, 40.3–50.4) and not statistically significant for pregnancy rate at 65.2% (95% CI, 60.6–69.8) versus 61.1% (95% CI, 56.2–66.1). Early pregnancy loss was statistically significantly decreased for the TMS group with 16.6% (95% CI, 12.6–21.4) versus 25.8% (95% CI, 20.6–31.9). The implantation rate was statistically significantly increased at 44.9% (95% CI, 41.4–48.4) versus 37.1% (95% CI, 33.6–40.7).

Conclusion(s):

The strategy of culturing and selecting embryos in the integrated EmbryoScope time-lapse monitoring system improves reproductive outcomes.

Clinical Trial Registration Number:

NCT01549262.

Read the full text at: http://www.fertstert.org/article/S0015-0282(14)01365-X/fulltext


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Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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