Embryo transfer represents the most critical step in IVF; however, this highly operator-dependent procedure has not evolved significantly since the first description of its use. In this study, Premium Fertility investigators propose a new method of embryo transfer using high-precision automated injection of embryos into the uterus to minimize expulsion, facilitate implantation, and minimize inter- and intra-operator variability. If successful, TDS will provide for safe and consistent embryo transfer and will be transformative in the most critical procedure of fertility treatments, potentially increasing the success rates of such therapies.
The TDS is a medical device used in embryo transfer processes in patients undergoing ART, and it's a semi-automated piece of medical equipment designed to inject an embryo or a fertilized ovum into the maternal uterine endometrium through the lumen of the female reproductive system. The system is made up of two instruments and different consumables:
* CEC device: an instrument embryologists use to collect the human embryo for transfer and performs the functions of wetting the needle and collecting the embryo. This instrument does not interact with the patient.
* CET device: an instrument gynecologists use to inject an embryo into the maternal uterine endometrium. This instrument is placed in the embryo transfer room and has an umbilical cable controlling the TD needle that ultimately injects the embryo in the endometrial tissue. None of the CET components come into direct or indirect contact with the patient.
* Consumables:
* TD needle: Performs embryo collection in the embryology laboratory and embryo injection into the maternal uterine endometrium.
* TD catheter: Used to introduce the TD needle and TD camera through the lumen of the female reproductive system during the transfer; the TD catheter is fixed using the TD speculum lock to keep the needle in stable position during the automatic injection of the embryo. It has a membrane tip at the distal end.
* TD speculum lock: Fixing the TD catheter to the speculum allows TD catheter placement; manual blocking when it contacts the endometrium ensures a fixed position of the catheter and needle for embryo injection.
* TD camera: Video and lighting using fiber optics improve the visibility of the vaginal mucosa and the location of the endometrium surface for correct implantation.
The aim of the study is to assess whether the medical device - Transfer Direct System (TDS) - is a safe and effective method for embryo transfer.
This is a prospective, open-label, controlled, non-randomized, multi-center, intervention clinical trial with a Class IIA medical device. The trial has a single assignment group aimed at patients of reproductive age who attend the clinic with a desire for a child and undergo Assisted Reproduction Treatment (ART) with an euploid single embryo transfer (SET) after corresponding hormone replacement therapy (HRT) has been carried out. The inclusion of 80 patients in the study group is expected and will be recruited in at least 2 reference IVF clinics.
Anonymized data from patients receiving euploid single embryo transfer will be used as a control group. For this purpose, data of patients that accomplished the same inclusion criteria will be analysed.
The total expected duration of the study is estimated to be approximately 12 months:
* Six months of recruitment period.
* Three months of approximate total duration of the treatment for each patient.
* Four months to analyze the results, make conclusions, and prepare the final report (overlapped with previous phase).
The study consists of 5 visits:
V1. Starting visit: the Informed Consent Form will be obtained for those patients who come to the clinic to undergo Assisted Reproduction Treatment with Single Embryo Transfer and meet the selection criteria.
V2. Ultrasound and blood test monitoring: the patients will undergo endometrial preparation according to usual clinical practice, preferably with HRT.
V3. Transfer visit: during this visit, embryo transfer will be performed with TDS. Next, the patient will be specifically asked to assess the degree of pain or discomfort from the procedure using an EVA chart, and uterine contractions will be assessed with ultrasound before and after embryo transfer.
V4. Beta performance visit: once the embryo transfer is complete, β-hCG levels will be measured on a blood sample between 10 and 12 days after transfer.
V5. Final visit: in the event of an ongoing pregnancy, a gestational control will be carried out between weeks 8-10 of gestation.
Data will be registered in an electronic Case Report Form (eCRF) specifically designed for this study. Monitoring activities and data verification will be performed during the whole study to ensure data quality, integrity and transparency.
