Transfer Direct System as a New Method for Embryo Transfer

NCT06744049 | Recruiting

• 1 other identifier: PF-TDS-XS-23-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

Infertility is defined as the inability to conceive within a year of unprotected intercourse. Infertility affects one in six couples and represents a public health problem causing feelings of helplessness, depression, and anxiety in both women and men worldwide. Despite the desire to become parents, up to 50% of infertile couples do not seek medical treatment, and 50-60% abandon treatment after two or three failed in vitro fertilization (IVF) cycles, even when the procedure is covered by insurance or public health. There are multiple reasons for this discontinuation; however, after removing cost considerations, psychological stress and poor prognoses represent the main reasons for stopping treatment. Clinical infertility treatments are generally ineffective. Success remains poor even with IVF, as evidenced by current live birth rates (LBRs) of only \~30% per initiated cycle. The primary challenge in ART lies mainly in the embryo implantation process, which remains the most significant bottleneck in IVF success, accounting for over 50% of ART failures. Embryo transfer (ET), the final step in IVF, has seen little technological advancement since its inception over four decades ago. The procedure is typically performed transcervically and largely relies in tactile sensation and operator's experience. Although a simple procedure, several potential negative factors may be linked to the low number of IVF pregnancies, including variations in catheter placement, the risk of uterine contractions and lack of control of intrauterine pressure and embryo placement can result in up to 15% of the transferred embryos being inadvertently expelled from the uterus. Therfore, ET's success is highly dependent on non-controllable variables as well as the skill and experience of the operator, resulting in significant inter-operator variability. Premium Fertility team has developed a controlled embryo transfer system - the Transfer Direct System (TDS) - that incorporates a visualization system to guide embryo delivery with the help of a fully automated microfluidic system that avoids initial phases of apposition and adhesion of implantation of human embryos. This technique places the embryo directly in the endometrial tissue, thereby minimizing the effects of embryo expulsion and potentially offering significant advantages such as the ability to visualize the uterine cavity through an endoscope at the time of embryo transfer and control the mechanics of the injection procedure to increase precision.

Conditions

Embryo Transfer

Keywords

Semi-automatization; Embryo implantation

Outcome Measures

Primary Outcomes (1)

• Safety of TDS in comparison with conventional transfer

  Incidence, prevalence and frequency of adverse events.

  From enrollment to final study visit at 8-10 weeks of pregnancy

Secondary Outcomes (4)

• Efficacy and non-inferiority of TDS

  up to 8-10 weeks

• pregnancy rate

  From enrollment to final study visit at 8-10 weeks of pregnancy

• ongoing gestation rate

  From enrollment to final study visit at 8-10 weeks of pregnancy

• miscarriage rate

  From enrollment to final study visit at 8-10 weeks of pregnancy

Study Arms (1)

Embryo transfer with Transfer Direct System (TDS)

EXPERIMENTAL

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.

Device: Transfer Direct System (TDS)

Interventions

Transfer Direct System (TDS) DEVICE

Class IIA medical device (according to rule 5 of Annex VIII of Regulation (EU) 2017/745 for medical devices). A semi-automated medical equipment designed to inject an embryo into the maternal uterine endometrium through the lumen of the female reproductive system.

Embryo transfer with Transfer Direct System (TDS)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Patients from 18 to 50 years of age without any disease that will undergo ART.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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).
• Women of reproductive age between 18 and 50 years (both inclusive)
• Body mass index (BMI): \<30 kg/m2
• Absence of adenomyosis and endometriosis
• 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.
• Absence of immune pathologies (e.g., lupus) that could endanger the health of the patient.
• Easy transfer test or history of embryo transfer without difficulty or factors that indicate that the transfer is easy.

You may not qualify if:

• Difficult or very painful transfer tests.
• Pathologies of an oncological nature.
• 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.
• 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.

Sponsors & Collaborators

• Premium Fertility: lead

Study Sites (4)

Dexeus Mujer Barcelona

Barcelona, Barcelona, 08028, Spain

NOT YET RECRUITING

Clínica FIV Valencia

Valencia, Valencia, 46021, Spain

NOT YET RECRUITING

Clínica Vida Recoletas Sevilla

Seville, 41092, Spain

RECRUITING

Clínica Next Fertility Valencia

Valencia, Spain

RECRUITING

Central Study Contacts

Érika Ortiz Domingo

CONTACT

+34 636 260 481; erika.ortiz@mshareservices.es

Xavier Santamaria

CONTACT

xavier.santamaria@ashermantherapy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical research with medical device.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)