Embryo TransferTDSNCT06744049
Transfer Direct System as a New Method for Embryo Transfer
A study testing Transfer Direct System (TDS) in people with Embryo Transfer, run by Premium Fertility at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Embryo Transfer
- What is being tested?
- Transfer Direct System (TDS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesSpain
- Study dates
- 21 Oct 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xavier Santamaria contact
Spain4 sites, 4 recruiting
- Not yet recruiting
Dexeus Mujer Barcelona
Barcelona, Barcelona, 08028
Nikolaos Polyzos, +34 932 27 47 00, nikpol@dexeus.com
Nikolaos Polyzos
- Recruiting
Clínica Vida Recoletas Sevilla
Seville, 41092
Manuel Fernández Sánchez, +34 653 65 09 95, manuel.fernandez@gruporecoletas.com
Manuel Fernández Sánchez
- Recruiting
Clínica FIV Valencia
Valencia, Valencia, 46021
Sara Maggi, +34 608 55 68 48, smaggi@fiv-valencia.es
Sara Maggi
- Recruiting
Clínica Next Fertility Valencia
Valencia
Luis Quintero, +34 667631006, luis.quintero@nextfertility.es
Luis Quintero
About this study
Official title: Assessment of Transfer Direct System (TDS) as a New Method for Embryo Transfer
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.
Read more
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 detailed 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.
- Conditions
- Embryo Transfer
- Being tested
- Transfer Direct System (TDS)
- Keywords
- Semi-automatization, Embryo implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transfer Direct System (TDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TDS in comparison with conventional transfer
Incidence, prevalence and frequency of adverse events.
Measured: From enrollment to final study visit at 8-10 weeks of pregnancy
Secondary outcomes (4)
Efficacy and non-inferiority of TDS
Implantation rate
Measured: up to 8-10 weeks
pregnancy rate
Efficacy and non-inferiority of TDS
Measured: From enrollment to final study visit at 8-10 weeks of pregnancy
ongoing gestation rate
Efficacy and non-inferiority of TDS
Measured: From enrollment to final study visit at 8-10 weeks of pregnancy
miscarriage rate
Efficacy and non-inferiority of TDS
Measured: From enrollment to final study visit at 8-10 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start21 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo TransferStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical research with medical device.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Premium Fertility
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744049
- Sponsor's protocol ID
- PF-TDS-XS-23-01
- Acronym
- TDS
- Status last verified
- Jun 2026
- First submitted
- 16 Dec 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Transfer Direct System (TDS) as a New Method for Embryo Transfer
- ClinicalTrials.gov ID
- NCT06744049
- Acronym / sponsor ID
- TDS / PF-TDS-XS-23-01
- Conditions
- Embryo Transfer
- Keywords
- Semi-automatization, Embryo implantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Premium FertilityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical research with medical device.
| Arm | Type | Receives |
|---|---|---|
| Embryo transfer with Transfer Direct System (TDS) | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfer Direct System (TDS)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. | Device | Embryo transfer with Transfer Direct System (TDS) |
Primary outcome
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.
4 secondary outcomes
Efficacy and non-inferiority of TDS
Time frame: up to 8-10 weeks
pregnancy rate
Time frame: From enrollment to final study visit at 8-10 weeks of pregnancy
ongoing gestation rate
Time frame: From enrollment to final study visit at 8-10 weeks of pregnancy
miscarriage rate
Time frame: From enrollment to final study visit at 8-10 weeks of pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xavier Santamaria contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfer Direct System (TDS) in people with Embryo Transfer, run by Premium Fertility at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Érika Ortiz Domingo (+34 636 260 481, erika.ortiz@mshareservices.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of TDS in comparison with conventional transfer (time frame: From enrollment to final study visit at 8-10 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.