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.
Study ID
NCT07396181
Status
Recruiting
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Conditions

  • ART
  • Infertility
  • Infertility (IVF Patients)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 38 Years
Healthy Volunteers
Not accepted

Interventions

  • Embryocase — DEVICE
    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 — DEVICE
    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 — DEVICE
    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 — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Feb 9, 2026
Start date
Jan 1, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • Experimental: TL/AI control group
    CRIO-ET manual without other interventions
  • Experimental: research group 1 TL/AI
    CRIO-ET manual + EMBRYOCASE
  • Experimental: research group 2 TL/AI
    CRIO-ET using EMBRYOPASS
  • Experimental: research group 3 TL/AI
    CRIO-ET using EMBRYOPASS + EMBRYOCASE

Primary Outcome Measure

Percentage of biochemical pregnancies [ Time Frame: From enrollment to 15 days after ET ]

Central Contacts

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