Actively Recruiting
Assessment of Transfer Direct System (TDS) as a New Method for Embryo Transfer
Led by Premium Fertility · Updated on 2026-03-05
80
Participants Needed
4
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Infertility affects many couples worldwide and is defined as the inability to conceive after one year of unprotected intercourse. This trial evaluates a new method for embryo transfer in assisted reproductive technology (ART) to improve success rates. The study focuses on overcoming limitations of traditional embryo transfer techniques, which rely heavily on the operator's skill and can result in embryo expulsion and implantation failure. The Premium Fertility team developed the Transfer Direct System (TDS), a device designed to enhance precision and control during embryo transfer. The TDS is a semi-automated medical device that allows high-precision injection of embryos directly into the uterine lining under visual guidance. It consists of two main instruments: one used by embryologists to collect embryos and another used by gynecologists for embryo injection. The system includes a camera for better visualization and various consumables to stabilize the procedure and improve accuracy. The trial is a prospective, open-label, controlled, non-randomized study involving 80 women undergoing ART with euploid single embryo transfer after hormone replacement therapy. Participants will attend five visits throughout the study: consent and screening, endometrial preparation monitoring, embryo transfer using TDS with pain and uterine contraction assessment, blood testing for pregnancy confirmation, and final gestational control if pregnancy continues. Data will be collected electronically and monitored for quality. The study aims to assess the safety and effectiveness of TDS compared to conventional embryo transfer methods, measuring outcomes such as pregnancy rates and miscarriage rates up to 8 to 10 weeks of pregnancy.
CONDITIONS
Brief Title
Transfer Direct System as a New Method for Embryo Transfer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have provided written informed consent after understanding the study details
- Undergoing assisted reproduction treatment with single euploid embryo transfer after hormone replacement therapy
- Women aged between 18 and 50 years inclusive
- Body mass index (BMI) less than 30 kg/m2
- No adenomyosis or endometriosis
- Uterus free of pathologies that could hinder embryo transfer or implantation (e.g., polyps, fibroids, Asherman syndrome)
- No immune system diseases that could risk patient health
- History of easy or uncomplicated embryo transfer procedures
You will not qualify if you...
- Difficult or very painful embryo transfer procedures
- Oncological diseases
- Serious or uncontrolled bacterial, fungal, or viral infections
- Other medical or psychiatric conditions posing risk or interfering with study outcomes, such as severe preeclampsia, uncontrolled heart diseases, or psychiatric disorders without specialist assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration as per clinical practice
Participants undergo endometrial preparation according to usual clinical practice, preferably with hormone replacement therapy (HRT).
Ultrasound and blood test monitoring visits
Duration - Single day procedure
Participants receive embryo transfer performed using the Transfer Direct System. After the procedure, pain or discomfort is assessed and uterine contractions are monitored by ultrasound.
1 transfer visit (in-person)
Duration - 1 day
Participants have blood drawn to measure β-hCG levels between 10 and 12 days after embryo transfer to assess pregnancy status.
1 visit (in-person)
Duration - Up to 2 weeks
In the event of an ongoing pregnancy, participants undergo gestational control between weeks 8 and 10 of pregnancy.
1 visit (in-person)
Trial Site Locations
Total: 4 locations
1
Dexeus Mujer Barcelona
Barcelona, Barcelona, Spain, 08028
Not Yet Recruiting
2
Clínica FIV Valencia
Valencia, Valencia, Spain, 46021
Not Yet Recruiting
3
Clínica Vida Recoletas Sevilla
Seville, Spain, 41092
Actively Recruiting
4
Clínica Next Fertility Valencia
Valencia, Spain
Actively Recruiting
Research Team
É
Érika Ortiz Domingo
X
Xavier Santamaria
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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