New method for embryo transfer using a semi-automated system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clínica FIV Valencia
  Valencia, Valencia, Spain Recruiting
• Clínica Vida Recoletas Sevilla
  Seville, Spain Recruiting
• Clínica Next Fertility Valencia
  Valencia, Spain Recruiting
• Dexeus Mujer Barcelona
  Barcelona, Barcelona, Spain Not yet recruiting
• Clínica Fertty
  Barcelona, Spain Active not recruiting

Study contacts

• Study coordinator: Érika Ortiz Domingo
• Email: erika.ortiz@mshareservices.es
• Phone: +34 636 260 481

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventing pre-eclampsia with low-dose aspirin in women after frozen embryo transfer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.