New method for embryo transfer using a semi-automated system
Assessment of Transfer Direct System (TDS) as a New Method for Embryo Transfer
NA · Premium Fertility · NCT06744049
This study is testing a new semi-automated system for embryo transfer to see if it can make the IVF process more precise and improve success rates for women trying to conceive.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Premium Fertility (other) |
| Locations | 4 sites (Barcelona, Barcelona and 3 other locations) |
| Trial ID | NCT06744049 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the Transfer Direct System (TDS), a semi-automated device designed to improve the embryo transfer process in assisted reproductive technology (ART). The TDS aims to enhance the precision of embryo implantation, reduce variability among operators, and ultimately increase the success rates of in vitro fertilization (IVF). By utilizing two specialized instruments, the CEC and CET devices, the study seeks to provide a safer and more consistent method for transferring embryos into the uterus. The trial will include women of reproductive age undergoing ART with specific eligibility criteria to ensure the safety and efficacy of the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 50 who are undergoing ART with at least one vitrified euploid blastocyst.
Not a fit: Patients with conditions such as adenomyosis, endometriosis, or other uterine pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly improve the success rates of embryo implantation and overall fertility treatments.
How similar studies have performed: While the approach of using semi-automated systems in embryo transfer is relatively novel, previous studies have indicated that improving precision in this process can lead to better outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients whose written informed consent is obtained, approved by the Ethics Committees for Investigation with Medicinal Products (ECRmp) after being duly informed of the nature of their disease and after voluntarily accepting the treatment program, knowing the potential risks, benefits, and inconveniences. 2. Patients who are going to undergo ART with a SET and have at least one vitrified euploid blastocyst with PGT-A (Preimplantation Genetic Test for the detection of Aneuploidy). 3. Women of reproductive age between 18 and 50 years (both inclusive) 4. Body mass index (BMI): \<30 kg/m2 5. Absence of adenomyosis and endometriosis 6. Uterus without pathologies that can contraindicate the transfer or may hinder implantation (e.g., polyps, fibroids that come into contact with the cavity, or Asherman syndrome) or without a history of thin endometrium or irregular patterns in thin endometrial preparations. 7. Absence of immune pathologies (e.g., lupus) that could endanger the health of the patient. 8. Easy transfer test or history of embryo transfer without difficulty or factors that indicate that the transfer is easy. Exclusion Criteria: 1. Difficult or very painful transfer tests. 2. Pathologies of an oncological nature. 3. The existence of serious or uncontrolled bacterial, fungal, or viral infections that, in the opinion of the principal investigator, may interfere with the patient's participation in the study or the evaluation of its results. 4. Other circumstances or difficulties that, in the opinion of the investigator, may pose a risk to the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, such as a history of severe preeclampsia without assessment by the obstetric team, psychiatric pathologies without prior assessment by the psychiatrist, uncontrolled or destabilized cardiac pathologies.
Where this trial is running
Barcelona, Barcelona and 3 other locations
- Dexeus Mujer Barcelona — Barcelona, Barcelona, Spain (NOT_YET_RECRUITING)
- Clínica FIV Valencia — Valencia, Valencia, Spain (NOT_YET_RECRUITING)
- Clínica Vida Recoletas Sevilla — Seville, Spain (RECRUITING)
- Clínica Next Fertility Valencia — Valencia, Spain (RECRUITING)
Study contacts
- Study coordinator: Érika Ortiz Domingo
- Email: erika.ortiz@mshareservices.es
- Phone: +34 636 260 481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Embryo Transfer, Semi-automatization, Embryo implantation