Effects of the microfluidic chip technique in sperm selection for intracytoplasmic sperm injection for unexplained infertility: a prospective, randomized controlled trial

Abstract

Purpose: The new-generation spermatozoon selection method, microfluidic technique called Fertile Chip® gives the chance to select spermatozoa with lower DNA fragmentation indexes. We aimed to determine the effect of microfluidic techniques for spermatozoon selection in ICSI treatment in patients with unexplained infertility.

Methods: This prospective randomized controlled study was conducted at a university hospital. One hundred twenty-two couples with unexplained infertility were included, in which 61 of them were treated with conventional swim-up techniques (control group) and another 61 with the microfluidic technique (study group) for spermatozoon selection in IVF treatment. The fertilization rates and the quality of embryos were the primary outcomes, and clinical pregnancy (CPR) and live birth rates (LBR) were the secondary outcomes of our study.

Results: CPR in the study group and control group were 48.3% and 44.8% (p = 0.35) and LBR were 38.3% and 36.2% (p = 0.48), respectively. The fertilization rates were similar (63.6% and 57.4%, p = 0.098). A total number of grade 1 embryos were significantly higher in microfluidic technique group than in control group (1.45 ± 1.62 vs. 0.83 ± 1.03, p = 0.01). There were more surplus top quality embryos leftover to freeze in the study group (0.71 ± 1.48 vs. 0.22 ± 0.69, p = 0.02).

Conclusion: Our study showed that the microfluidic technique does not change fertilization, CPR, and LBR during IVF treatment for couples with unexplained infertility. Despite the fact that the total number of grade 1 embryos after ICSI treatment and the surplus number of grade 1 embryos after embryo transfer were higher in the microfluidic technique group, the study was not powered to detect this difference.

Trial registration: NCT02488434.

Keywords: Embryo; ICSI; Microfluidic technique; Unexplained infertility.

Conflict of interest statement

The study protocol was approved by the Clinical Research and Ethics Committee (Project No: KA15/132) and from the Turkish Drug and Medical Device Institution of the Turkish Ministry of Health.

Figures

Fig. 1

The patient selection flowchart

Fig. 2

(a) schematic illustration of fertile chip channel systems. (b) Microscopic image of channel inlet under a 2X objective. (c) Image of swimming sperm cells inside a microchannel under a 10X objective. (d) Microscopic image of channel outlet under a 2X objective [16]