Clinical validation of pinopode as a marker of endometrial receptivity: a randomized controlled trial

Abstract

Objective: To determine the clinical value of pinopodes in the human.

Design: Randomized controlled trial.

Setting: Academic fertility center.

Patient(s): From December 2014 to December 2016, in a phase I trial, 363 patients were recruited in their first IVF cycles. In a phase II trial, 136 patients with at least two previous embryo implantation failures were recruited.

Intervention(s): In the phase I trial, in the midluteal phase, endometrial tissues were obtained for scanning electron microscopy, and their IVF treatment outcomes were followed up. In the phase II trial, participants were allocated into two groups by random number table, and the experimental group had twice the number of the control group. Individual ETs (iETs) were performed in the experimental group, while frozen-thawed embryos were routinely transferred in the control group.

Main outcome measure(s): Clinical pregnancy rate (CPR) and ongoing pregnancy rate (OPR).

Result(s): In the phase I trial, through receiver operation characteristic curve analysis, the optimal pinopode scoring for successful clinical pregnancy was determined to be 85. The CPR (74.29% vs. 19.77%) and OPR (62.86% vs 11.86%) were significantly higher in the patients whose pinopode scoring was >85. In the phase II trial, the CPR was dramatically higher in the iET group (33.82% vs. 8.11%).

Conclusion(s): Pinopode scoring is a reliable marker of endometrial receptivity, and iET based on pinopode scoring is a promising solution for recurrent implantation failure.

Trial registration numbers: ChiCTR-OOC-14005617; ChiCTR-OOC-15005882.

Keywords: Pinopode; individual embryo transfer; window of implantation.