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Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans
Sponsor: Przychodnia Lekarska nOvum Katarzyna Kozioł, Piotr Lewandowski sp.k.
Summary
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.
Official title: A Randomized, Prospective, Single-center, Controlled, Single-blind Study to Evaluate the Impact of Standardization of Variable Embryo Transfer Conditions in a Medically Assisted Procreation Procedure in Humans on the Effectiveness of the Procedure, by Using: Standardization of Culture Conditions and Selection of Embryo for Transfer Through the Use of an Incubator With a Time-lapse Observation System and AI, an Embryopass-electronically Controlled Device for Controlled ET, and the Embryocase Device Maintaining Optimal Environmental Conditions for the Embryo Outside the Incubator During ET Time
Key Details
Gender
FEMALE
Age Range
18 Years - 38 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-01-01
Completion Date
2027-10
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Embryocase
The 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
The 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
The 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
The 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.
Locations (1)
Przychodnia Lekarska nOvum Katarzyna Kozioł, Piotr Lewandowski sp.k.
Warsaw, Poland