Study to evaluate if the uterus is ready for embryo implantation in in vitro fertilization treatments
| ISRCTN | ISRCTN11352119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11352119 |
| Secondary identifying numbers | R010203_PG20-01_Seedchrony03_PIC, CPP2022-009720 |
- Submission date
- 06/10/2025
- Registration date
- 09/10/2025
- Last edited
- 09/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
In vitro fertilization (IVF) success rates remain below 40%, with embryo transfer being a leading cause of failure. This study aims to evaluate whether the concentration of a biomarker dissolved in uterine fluid (alone or in combination with other clinical data) can predict the outcome of embryo transfer to improve success rates.
Who can participate?
Female IVF patients aged 18-42 years undergoing frozen embryo transfer
What does the study involve?
A measurement of a biomarker dissolved in endometrial fluid is conducted on the day of embryo transfer using the investigational device Seedchrony (RUO 02). The measurement results are hidden to both investigators and participants and do not influence clinical decision-making.
What are the possible benefits and risks of participating?
Participation offers no direct personal benefit, but it may help develop a device to assess uterine readiness for embryo implantation on transfer day, informing whether to proceed or defer the transfer to improve IVF success and reduce attempts. Risks are similar to standard embryo transfer: possible mild discomfort from the catheter (reduced by arriving with a full bladder) and a small risk of bleeding or infection, kept less than 0.1% with sterile technique.
Where is the study run from?
Vall d’Hebron Research Institute (VHIR) and Manina Medtech SL (Spain)
When is the study starting and how long is it expected to run for?
July 2025 to July 2026
Who is funding the study?
In addition to private funding from Manina Medtech, this study is supported by the project CPP2022-009720, funded by the Spanish State Research Agency (AEI), and co-financed by the European Union through NextGenerationEU/PRTR.
Who is the main contact?
Dr Gina Abello Sumpsi, gina.abello@maninamedtech.com
Contact information
Principal investigator
Pg. de la Vall d'Hebron, 119
Barcelona
08035
Spain
| Phone | +34 (0)934893177 |
|---|---|
| melchor.carbonell@vallhebron.cat |
Public
Carrer de la Llacuna, 162-164
Barcelona
08018
Spain
| Phone | +34 (0)934 34 11 69 |
|---|---|
| gina.abello@maninamedtech.com |
Scientific
Carrer de la Llacuna, 162-164
Barcelona
08018
Spain
| Phone | +34 (0)934 34 11 69 |
|---|---|
| monica.delavega@maninamedtech.com |
Study information
| Study design | Exploratory open-label single-arm multicenter study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Open-label, single-arm |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Clinical research to estimate the predictive capacity of SEEDCHRONY on the success of the cryotransfer with a single euploid blastocyst: Seedchrony03 |
| Study acronym | Seedchrony03 |
| Study objectives | The objective of this investigation is to assess whether the concentration of an intrauterine biomarker (alone or in combination with other embryo and patient clinical variables), measured on the day of embryo transfer, can predict embryo transfer outcomes. |
| Ethics approval(s) |
Approved 18/07/2025, Ethics board from the University Hospital Vall d'Hebron (VHIR Edifici Central, Pg. de la Vall d'Hebron, 129, Horta-Guinardo, Barcelona, 08035, Spain; +34 (0)934893000; ceic@vhir.org), ref: PS(AG)029/2025(6480) |
| Health condition(s) or problem(s) studied | Uterine readiness for embryo transfer in IVF patients undergoing euploid blastocyst transfer |
| Intervention | 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Seedchrony RUO 02 |
| Primary outcome measure | 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 outcome measures | 1. Biochemical pregnancy outcome assessed using a serum β-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 |
| Overall study start date | 18/07/2025 |
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 42 Years |
| Sex | Female |
| Target number of participants | 62 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 27/10/2025 |
| Date of final enrolment | 23/03/2026 |
Locations
Countries of recruitment
- Spain
Study participating centres
Barcelona
08021
Spain
Barcelona
08006
Spain
Barcelona
08006
Spain
Palma Mallorca
07006
Spain
Sponsor information
Industry
C/ Llacuna, 162-164
Barcelona
08018
Spain
| Website | https://www.maninamedtech.com/ |
|---|
Research organisation
VHIR Edifici Central
Pg. de la Vall d'Hebron, 129
Horta-Guinardo
Barcelona
08035
Spain
| Website | https://vhir.vallhebron.com/en |
|---|---|
"ROR" |
https://ror.org/01d5vx451 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Spanish State Research Agency, Spanish Agencia Estatal de Investigación, AEI
- Location
- Spain
No information available
No information available
Results and Publications
| Intention to publish date | 01/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analyzed during this clinical investigation will remain confidential and will not be publicly shared, as they contain proprietary information subject to intellectual property protection. Following publication of the study findings, summary analyses and integrated data will be made available, but access to raw datasets will be restricted to ensure data integrity and protection of trade secrets. |
Editorial Notes
07/10/2025: Study's existence confirmed by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).
