The EFECT study is a clinical trial designed to determine whether improving the consistency of embryo transfer procedures can increase pregnancy success in patients undergoing frozen embryo transfer (cryoET). While laboratory techniques for fertilization, embryo culture, and selection have advanced significantly, the process of transferring embryos to the uterus remains variable and depends on small procedural differences, such as temperature changes, mechanical forces, timing, and individual operator techniques. These variations may affect embryo survival and implantation, ultimately influencing pregnancy outcomes.
This study tests whether using specialized devices to standardize key aspects of embryo transfer-specifically temperature stability during transport and controlled, precise embryo aspiration and expulsion speed, optimal fluid volume, programmed injection time, elimination of pressure fluctuations and plunger backflow, prevention of embryo re-aspiration and detection of transfer catherer oclusion-can improve pregnancy rates. All embryos in the study are cultured using time-lapse monitoring and selected using artificial intelligence-supported grading, ensuring uniform quality for all participants. The study compares standard manual embryo transfer with transfer using one or both of the devices: Embryocase, which maintains a stable temperature during transport, and Embryopass, which standardizes the procedure and eliminates human factor.
A total of 160 participants are randomly assigned to one of four groups: manual transfer without device support, manual transfer with Embryocase, transfer with Embryopass, or transfer with both devices. Participants and outcome assessors are blinded to group assignment, while the staff performing the transfer are aware due to the nature of the devices. All participants receive standard luteal phase support with progesterone following routine clinical practice.
The study's main goal is to evaluate whether these procedural improvements lead to higher rates of biochemical pregnancy (positive pregnancy test) and clinical pregnancy (confirmed by ultrasound). Secondary outcomes include implantation rate, live birth rate, device safety, and ease of use as reported by staff. Pregnancy outcomes, including delivery, pregnancy loss, or ectopic pregnancy, are followed until the end of pregnancy.
By investigating the impact of procedural standardization, this study aims to determine whether technological improvements during embryo transfer can increase the effectiveness of assisted reproductive treatments. If successful, the results could support the broader adoption of standardized, device-assisted embryo transfer protocols in fertility clinics, helping more patients achieve successful pregnancies.
The patient and her partner gave written, informed consent to participate in the clinical trial.
The patient underwent a medically assisted procreation procedure using IVF or ICSI in accordance with the applicable law, did not have a fresh transfer, has all frozen embryos in the blastocyst stage, of which at least 1 is of good quality
You and your partner are not currently taking part in or have not participated in any other clinical trial in the last 6 months.
The patient's age on the day of screening ranges from ≥18 to ≤38 years.
Failure to meet the inclusion criteria.
The patient was found to have abnormalities in the anatomical structure of the uterus and reproductive tract, which, according to the researcher, could reduce the chances of getting pregnant.
The patient was diagnosed with endometrial polyp(s).
The patient was diagnosed with submucosal or intramural uterine fibroids.
Factorial
Embryocase
DeviceThe embryologist will collect embryos into the transfer catheter in a manual manner, according to the above scheme adopted at the center. After collecting the embryos into the catheter, the embryologist will transfer the catheter to the transfer room after placing the catheter with the embryo in the Embryocase device to protect the catheter from the suboptimal environmental conditions . The doctor will administer embryos from the transfer catheter into the uterine cavity in manual maner without using any other devices (group 1).
Embryopass
DeviceThe embryologist will collect embryos into the transfer catheter with the help of the Embryopass applicator, in accordance with its instructions for use. After collecting the embryos into the catheter, the embryologist will transfer the catheter to the transfer room without additional protection. The doctor will administer embryos from the transfer catheter into the uterine cavity using the Embryopass applicator, according to its instructions for use (study group 2).
Embryocase+Embryopass
DeviceThe embryologist will collect embryos into the transfer catheter with the help of the Embryopass applicator, in accordance with its instructions for use. After collecting the embryos into the catheter, the embryologist will transfer the catheter to the transfer room after placing the catheter with the embryo in the Embryocase device to protect the catheter from the suboptimal environmental conditions. The doctor will administer embryos from the transfer catheter into the uterine cavity using the Embryopass applicator, according to its instructions for use (group 3)
Manual cryo transfer without using any devices
Procedure/SurgeryThe embryologist will collect embryos into the transfer catheter in a manual manner, according to the scheme adopted at the center without any devices. After collecting the embryos into the catheter, the embryologist will transfer the catheter to the transfer room without additional protection. The doctor will administer embryos from the transfer catheter into the uterine cavity in a manual manner without using any devices.
Percentage of biochemical pregnancies
1. confirmation of the positive impact of standardization of the environmental conditions in which the embryo is located outside the incubator during the peritransfer time will be an increase in the percentage of pregnancies (βhCG result indicating pregnancy 10-15 days after embryo transfer) in the group of patients in whom ET was performed with the help of the Embryocase by 10% compared to the control; 2. confirmation of the effectiveness of the Embryopass - achieving at least the same percentage of pregnancies in the group of patients in whom ET was performed with the help of the Embryopass applicator in relation to the control 3. confirmation of the effectiveness of standardization of variable conditions in the ET procedure (environmental changes and the human factor) will be an increase in the percentage of pregnancies in the group of patients in whom ET was performed with the help of the Embryocase in combination with the Embryopass applicator compared to control by 15%
Percentage of clinical pregnancies in all groups of patients
Percentage of clinical pregnancies in all groups of patients (visible gestational follicle at 25 - 35 days after ET).
confirmation of the beneficial impact of standardization of parameters and conditions of the ET procedure on its effectiveness
Confirmation of the beneficial impact of standardization of parameters and conditions of the ET procedure on its effectiveness achieved thanks to the use of the Embryocase case and the Embryopass applicator - an electronically controlled device for controlled embryo transfer by: obtaining an increased percentage of implantation (percentage of implanted embryos) - visible pregnancy follicle in ultrasound 25-35 days after ET in the group of patients in whom ET was performed with the help of the Embryocase case, Embryopass applicator, and Embryocase in combination with Embryopass compared to a control group in which ET was performed according to the standard procedure adopted at the center (manually).
Estimating the impact of using the Embryocase case and the Embryopass applicator separately and in combination on the percentage of live births - LBR (after completion of the study).
Estimating the impact of using the Embryocase case and the Embryopass applicator separately and in combination on the percentage of live births - LBR (after completion of the study).
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Przychodnia Lekarska nOvum Katarzyna Kozioł, Piotr Lewandowski sp.k.
Lead sponsor
Fundusze Europejskie dla Mazowsza 2021-2027 (FEMA.01.01-IP.01-04WN/24)
Collaborator
