Automated Embryo Transfer Using the Transfer Direct System for Women Undergoing IVF Treatment A Prospective Clinical Trial Evaluating Safety and Efficacy

What this Trial Is About

Infertility affects many couples worldwide, causing emotional distress and challenges in conception. This study evaluates a new embryo transfer method using the Transfer Direct System TDS, a semi-automated medical device designed to improve embryo placement during in vitro fertilization IVF. The goal is to address the main difficulty in assisted reproductive treatments, which is the embryo implantation process, and reduce variability caused by manual techniques. The TDS system includes instruments used by embryologists and gynecologists to collect and inject embryos directly into the uterine lining with high precision. It features a camera for real-time visualization and tools to stabilize the catheter and needle during transfer. This controlled method aims to reduce embryo expulsion and enhance implantation. Participants receive hormone replacement therapy before undergoing a single embryo transfer using TDS. Participants attend five clinic visits, including initial consent, ultrasound and blood monitoring, the embryo transfer procedure, pregnancy hormone testing, and gestational follow-up. Researchers will collect data on safety, pregnancy rates, ongoing gestation, and miscarriage rates. Data quality is ensured through continuous monitoring, and the study is expected to last about 12 months, with analysis and reporting after treatment completion.

Transfer Direct System as a New Method for Embryo Transfer