Transfer Direct System as a New Method for Embryo Transfer
Embryo Transfer
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 50 years
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 80 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Embryo transfer with Transfer Direct System (TDS)
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)
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Safety of TDS in comparison with conventional transfer
Time frame: From enrollment to final study visit at 8-10 weeks of pregnancy
Incidence, prevalence and frequency of adverse events.
Secondary measures
Efficacy and non-inferiority of TDS
Time frame: up to 8-10 weeks
Implantation rate
pregnancy rate
Time frame: From enrollment to final study visit at 8-10 weeks of pregnancy
Efficacy and non-inferiority of TDS
ongoing gestation rate
Time frame: From enrollment to final study visit at 8-10 weeks of pregnancy
Efficacy and non-inferiority of TDS
miscarriage rate
Time frame: From enrollment to final study visit at 8-10 weeks of pregnancy
Efficacy and non-inferiority of TDS
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (5)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
5 locations
Dexeus Mujer BarcelonaBarcelona, Barcelona, SpainNot yet recruiting
Clínica FIV ValenciaValencia, Valencia, SpainRecruiting
Clínica FerttyBarcelona, SpainActive, not recruiting
Clínica Vida Recoletas SevillaSeville, SpainRecruiting
Clínica Next Fertility ValenciaValencia, SpainRecruiting
Study team and timeline
- Lead sponsor
- Premium Fertility
- Study start
- Oct 21, 2024 Actual
- Primary completion
- 2026-12 Estimated
- Study completion
- 2027-03 Estimated
- First posted
- Dec 20, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Assessment of Transfer Direct System (TDS) as a New Method for Embryo Transfer
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026