Standardizing embryo transfer steps for frozen embryo transfers

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

This trial tests whether using specialized transfer devices to keep embryos warm and deliver them with precise, controlled motion can increase pregnancy success for people having frozen embryo transfer after IVF/ICSI.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 38 Years
• Sex: Female
• Sponsor: Przychodnia Lekarska nOvum Katarzyna Kozioł, Piotr Lewandowski sp.k. (other)
• Locations: 1 site (Warsaw)
• Trial ID: NCT07396181 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, controlled, single-center trial comparing dedicated transfer-support devices (Embryocase, Embryopass, and their combination) with standard manual cryo-embryo transfer. All embryos are blastocysts produced by IVF or ICSI, cultured with time-lapse monitoring, and selected using AI-based grading to reduce selection variability. The devices are designed to stabilize temperature during transport and to control aspiration/expulsion speed, fluid volume, and pressure dynamics during transfer to minimize mechanical stress and re-aspiration. Pregnancy outcomes after frozen embryo transfer will be compared across groups to see if procedural standardization improves implantation and clinical pregnancy rates.

Who should consider this trial

Good fit: People aged 18–38 with BMI 18 to <30 undergoing frozen blastocyst transfer after IVF or ICSI who have at least one good-quality blastocyst and agree to time-lapse/AI-supported embryo selection are the intended participants.

Not a fit: Patients having fresh transfers, transfers of non-blastocyst-stage embryos, those outside the age or BMI ranges, or who cannot attend the single center are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the approach could raise implantation and pregnancy rates for patients having frozen embryo transfer by reducing temperature and mechanical stress during transfer.

How similar studies have performed: Some observational and device feasibility reports suggest procedural factors can affect implantation, but randomized data on standardized transfer devices remain limited.

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.
* 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).
* The patient is to have an incision made in the AH areola before the ET procedure.
* The patient wants to have Embryoglue used for transfer.
* The patient takes heparin, Clexane, Acesan, Relanium drugs on and after embryo transfer.

Where this trial is running

Warsaw

• Przychodnia Lekarska nOvum Katarzyna Kozioł, Piotr Lewandowski sp.k. — Warsaw, Poland (RECRUITING)

Study contacts

• Study coordinator: Katarzyna Kozioł, MD

Conditions: Infertility, ART, ET, cryo-ET, AI, Embryopass, Embryocase, embryo transfer