Study to evaluate if the uterus is ready for embryo implantation in in vitro fertilization treatments

Clinical research to estimate the predictive capacity of SEEDCHRONY on the success of the cryotransfer with a single euploid blastocyst: Seedchrony03

Registry ID
ISRCTN11352119
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Manina Medtech
Enrollment
62
Start date
2025-10-27
Completion date
2026-10-31
Last update
2026-08-17

Conditions

Summary

Uterine readiness for embryo transfer in IVF patients undergoing euploid blastocyst transfer

Detailed description

An intrauterine measurement of a biomarker dissolved in endometrial fluid will be conducted on the day of embryo transfer using the investigational device Seedchrony (RUO). This device incorporates a microsensor within a guiding catheter to quantify biomarker levels in uterine fluid entering the catheter. The measurement procedure lasts approximately 2 minutes. A blood sample will also be collected on the day of embryo transfer for biomarker analysis.

Interventions

Inclusion criteria

1. Patients who have signed the informed consent form 2. Patients with a body mass index (BMI) ≤30 kg/m² 3. Patients undergoing their first transfer cycle with a vitrified euploid blastocyst selected according to PGT-A 4. Patients eligible for a modified natural transfer cycle with ovulation trigger and luteal phase support 5. Patients with an endometrial thickness ≥ 7 mm and a trilaminar pattern on the day of the trigger visit 6. Patients scheduled for a single embryo transfer of a day 5 euploid blastocyst 7. Patients scheduled to undergo embryo transfer after 120 hours of progesterone exposure

Exclusion criteria

1. Patients with a prior history of repeated pregnancy loss (two or more miscarriages). 2. Patients with a prior history of recurrent implantation failure (RIF), defined as failure of three or more transfers with A/B-quality embryos from at least two different cycles, or failure of one or more transfers with a euploid embryo. 3. Use of sperm obtained from a testicular biopsy. 4. Patients diagnosed with at least one of the following medical conditions: insulin-dependent diabetes mellitus, Cushing’s syndrome, uncorrected thyroid dysfunction, liver and/or kidney failure, or antiphospholipid syndrome. 5. Patients currently taking any anti-inflammatory drugs that may influence prostaglandin production (e.g., ibuprofen, naproxen, indomethacin, mesalazine). 6. Lack of adequate understanding, oral or written, of the clinical research protocol and informed consent form.

Locations

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