An unpublished preview of a next-generation embryo transfer system. Classical transfer is operator-dependent and outcome is shaped by injection velocity, intrauterine pressure and medium viscosity — variables the embryologist cannot control once the catheter leaves the cervix. The proposed direct-injection system uses a 2.1 mm catheter with on-board camera, micro-injection needle plunger, capacity sensing for endometrial localisation, and live image guidance to deposit the embryo at a defined intra-endometrial depth.
After classical transfer the embryo position predicts the implantation site only 50% of the time. In 23-57% of cases methylene-blue flows back through the cervix during a standard injection. The system has cleared a primate preclinical safety study (Macaca mulatta, Oregon Primate Center) and a feasibility study in hysterectomised human uteri (Valencia). Regulatory approval from the European Medical Agency has been obtained; first-in-human trials are scheduled to start in two Spanish clinics in October 2024.
Classical embryo transfer technique remains the standard for now. The concept reframes the next bottleneck after embryo selection as the act of transfer itself: 'one euploid embryo, one baby at home'. Follow the first-in-human results expected over the next 2 years before drawing clinical conclusions.
The animal cervix is a poor analogue of the human, so feasibility data in primates needs replication in human trials. Direct intra-endometrial injection raises questions about local trauma, infection risk and how it interacts with HRT versus natural-cycle endometrium. The technology is preclinical-to-investigational; it is not a current treatment option.
How much of IVF failure happens after the transfer catheter leaves the cervix? An unpublished preview of next-generation embryo transfer — robotic microfluidic injection into a defined endometrial pocket under image guidance, on the way to first-in-human trials.
Professor of Obstetrics and Gynecology at the University of Valencia and Founder of the Carlos Simón Foundation for Research in Women's Health. Internationally recognized for his pioneering work on the human endometrium and endometrial receptivity, including the development of the Endometrial Receptivity Array (ERA). Recipient of the ASRM Distinguished Researcher Award and author of more than 500 scientific publications.
Author of the lecture "Direct embryo transfer: a new automated technique"