Uterine readiness for embryo transfer in IVF patients undergoing euploid blastocyst transfer Pregnancy and Childbirth
Conditions
Interventions
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
Sponsors
Manina Medtech
Vall d'Hebron Institut de Recerca
Eligibility
Sex/Gender
Female
Age
18 Years to 42 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/08/2026: 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 or second transfer cycle with a vitrified euploid blastocyst selected according to PGT-A 4. Patients eligible for a natural cycle or modified natural transfer cycle with ovulation trigger and, both with 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 +/- 3 of progesterone exposure Previous 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
Exclusion criteria: Current exclusion criteria as of 25/08/2026: 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 two 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. Previous 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Concentration of a biomarker dissolved in the endometrial fluid measured using the medical device Seedchrony (RUO 02) during 2 minutes on the embryo transfer day. 2. Clinical pregnancy outcome assessed by ultrasound at post-transfer week 4. Results will be record as positive or negative. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biochemical pregnancy outcome assessed using a serum ß-hCG (pregnancy) test conducted 10–14 days after embryo transfer. The result will be recorded as positive or negative 2. Seedchrony algorithm accuracy calculated as the proportion of correct predictions (true positives + true negatives) by the total number of predictions 3. Seedchrony algorithm sensitivity calculated as the number of true positives divided by the total number of actual positives (true positives + false negatives) 4. Seedchrony algorithm specificity calculated as the number of true negatives divided by the total number of actual negatives (true negatives + false positives) 5. Pain measured using the visual analogue score (VAS) after intrauterine biomarker measurement 6. End-user experience assessed through a short questionnaire administrated after every intrauterine measurement 7. Seedchrony performance evaluated by recording and reporting any erroneous readings, device malfunctions or software failures observed during the trial 8. Seedchrony safety monitored by reporting adverse events and serious adverse events related to the investigational device during the trial, as well as any operational or safety incidents not previously identified in earlier studies or risk analyses | — |
Countries
Spain
Contacts
Public ContactGina Abelló
Outcome results
None listed