Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans

NCT07396181 | Recruiting

• 1 other identifier: KB/1546/25
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility; ART; Infertility (IVF Patients)

Keywords

ET; cryo-ET; AI; Embryopass; Embryocase; embryo transfer; device; standardization; efect; controlled; Infertility

Outcome Measures

Primary Outcomes (2)

• 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%

  From enrollment to 15 days after ET

• 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).

  From enrollment to 35 days after ET

Secondary Outcomes (2)

• confirmation of the beneficial impact of standardization of parameters and conditions of the ET procedure on its effectiveness

  From enrollment to 35 days after ET

• 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).

  From enrollment of a patient to the 9 months after labour of the last enrolled patient

Study Arms (4)

TL/AI control group

EXPERIMENTAL

CRIO-ET manual without other interventions

Procedure: Manual cryo transfer without using any devices

research group 1 TL/AI

EXPERIMENTAL

CRIO-ET manual + EMBRYOCASE

Device: Embryocase

research group 2 TL/AI

EXPERIMENTAL

CRIO-ET using EMBRYOPASS

Device: Embryopass

research group 3 TL/AI

EXPERIMENTAL

CRIO-ET using EMBRYOPASS + EMBRYOCASE

Device: Embryocase+Embryopass

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).

research group 1 TL/AI

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).

research group 2 TL/AI

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)

research group 3 TL/AI

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.

TL/AI control group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: Embryo transfer is performed only in females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• The patient's BMI on the day of screening ranges from ≥18 to \< 30.
• Both partners have normal infectious tests performed 6 months before ET and bacteriological tests performed one month before ET.
• The patient has had IVF or ICSI embryo culture performed in an incubator with a Time Lapse monitoring system and an Artificial Intelligence system (or if not, the embryo will be placed in the EmbryoScope after thawing) and has not had a fresh transfer (all embryos after stimulation and puncture have been frozen), and after thawing she has at least 1 good quality blastocyst evaluated before freezing by an embryologist as a good quality blastocyst or bl class. 3.2.2. The embryos have also been evaluated by AI prior to freezing and will be thawed in the future in order of the highest AI-confirmed rating.
• The patient has a normal uterus and endometrium at least 7 mm on ET.
• The patient must be prepared for cryotransfer in the ovulatory cycle with natural or induced letrozole, and after ovulation in the current cycle, take a progesterone preparation at the doses specified above for luteal phase supplementation.
• On the day of transfer (5th day after ovulation), the patient must have at least one thawed, developed embryo of good quality - pre-frozen blastocyst 3.2.2 thawed according to the highest AI rating.
• The patient must be qualified by the doctor for the procedure embryo transfer on day 5 after ovulation.
• Embryo transfer was performed without general anesthesia or other procedures and/or additional antispasmodic drugs prior to transfer (e.g. oxytocin antagonist) with the exception of routine preparation (drotaverine 1 table and 20 mg p.o. per hour prior to transfer).

You may not qualify if:

• 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.
• The patient was diagnosed with fallopian tube hydromas.
• The patient was diagnosed with ≥3 endometriosis.
• The patient or her partner is a carrier of a genetic defect that may have an impact on lowering fertility.
• The patient or her partner is currently or has been undergoing cancer treatment in the past, which may have had a negative impact on fertility.
• The patient has had 1 unsuccessful embryo transfer in the past, which means no clinical pregnancy.
• During the trial transfer in the preceding cycle, difficulties in entering the uterine cavity (the so-called difficult transfer) were found or if the patient had had an embryo transfer in the past and it was described as difficult, even if she became pregnant as a result.
• Embryos are formed from eggs after PBB (polar body biopsy) of oocytes have been examined or have undergone genetic testing of embryos.
• The embryos were formed from oocytes after cryopreservation.
• Semen was obtained for a procedure other than normal ejaculation (retrograde bladder ejaculation, epididymis biopsy, testicular biopsy, M-TESE).
• The patient did not take progesterone for luteal phase supplementation.
• Inability to perform embryo transfer on day 5 after ovulation due to medical or random reasons.
• The patient has indications for general anesthesia or pre-transfer antispasmodic procedure/medication (oxytocin receptor antagonist other than Drotaverine, or others that may affect implantation (intralipid, neupogen, and other significant in the investigator's judgment).

Sponsors & Collaborators

• Fundusze Europejskie dla Mazowsza 2021-2027 (FEMA.01.01-IP.01-04WN/24): collaborator
• Przychodnia Lekarska nOvum Katarzyna Kozioł, Piotr Lewandowski sp.k.: lead

Study Sites (1)

Przychodnia Lekarska nOvum Katarzyna Kozioł, Piotr Lewandowski sp.k.

Warsaw, 02-807, Poland

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Katarzyna Kozioł, MD

CONTACT

(+48) 22 566 80 00; katarzyna.koziol@novum.com.pl

Sylwia Trubacz, mgr inż.

CONTACT

sylwia.trubacz@novum.com.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will be based on a 1:1:1:1 basis. This means that 40 patients will be placed in the control group and each of the three groups of subjects. TL/AI control group - CRIO-ET manual research group 1 TL/AI - CRIO-ET manual + EMBRYOCASE study group 2 TL/AI - CRIO-ET using EMBRYOPASS research group 3 TL/AI - CRIO-ET using EMBRYOPASS + EMBRYOCASE

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: February 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)