InfertilitySeedchrony02NCT06259084
Study to Estimate Seedchrony's Predictive Capacity in the Success of Embryo Implantation.
A study testing Seedchrony in people with Infertility, run by Manina Medtech at 1 site in Spain.
Trial summary
In Vitro Fertilization (IVF) success is below 40%, with Embryo Transfer the leading cause of IVF failure. This clinical investigation aims to evaluate if the levels of an intrauterine biomarker dissolved in the uterine fluid (alone or as a complex biological marker) can predict the outcome of embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Seedchrony
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2024to 26 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- First IVF cycle patients
- Patients who sign the informed consent form
- Patients between 18 and 37 years old.
- Patients BMI ≤ 30
- Patients who have frozen blastocysts of good quality (grade A or B)
- Patients with negative vaginal and endocervical cultures
Show all 11Show fewer
- Patients with an antimullerian hormone level greater than 1 ng/mL.
- IVF patients with an endometrial thickness greater than 7mm with trilaminar pattern on the day of the pre-progesterone visit.
- And who meets one of these conditions:
- Not having had a previous embryo transfer.
- Have failed only one embryo transfer
Who cannot join
- Patients with seminal data of the couple with severe oligozoospermia (sperm concentration <1 million sperm per ml) or azoospermia (absence of sperm in the ejaculate)
- Patients diagnosed with at least one of the following uterine pathologies: endometriosis, cancer, malformations, untreated polyps, or submucous fibroids.
- Patients diagnosed with at least one of the following medical pathologies: Polycystic ovary syndrome (PCOS), insulin-dependent diabetes mellitus, Cushing's syndrome, uncorrected thyroid dysfunction, hepatic and/or renal insufficiency, a pathology that contraindicates ovarian stimulation and/or gestation, antiphospholipid syndrome, and autoimmune disease.
- Patients who are currently taking any medication other than contraceptive treatments, which may interfere with fertility or menstrual cycle regulation.
- Evidence of drug, tobacco, or alcohol abuse or dependence according to medical history or information provided by the patient.
- Inadequate understanding (oral and written) of the Spanish language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Detect the Predictive Capacity of a Composite Biological Marker in the Success of Embryonic Implantation in Fertilization Treatments In Vitro (IVF): Seedchrony Pilot.
In Vitro Fertilization (IVF) success is below 40%, with Embryo Transfer the leading cause of IVF failure. This clinical investigation aims to evaluate if the levels of an intrauterine biomarker dissolved in the uterine fluid (alone or as a complex biological marker) can predict the outcome of embryo transfer.
Read the detailed description
Seedchorny02 is an exploratory study, with blind evaluation by third parties, in a single center and without influencing clinical practice. The goal of this investigation is to evaluate if the levels of an intrauterine biomarker that is dissolved in the endometrial fluid can predict the outcome of embryo transfer, when measured the day before or on the day of embryo transfer.
80 IVF volunteers in a frozen embryo transfer cycle with high-quality day-five blastocysts are expected to be recruited. For intrauterine measurement, the investigational device Seedchrony RUO 02 will be used. Seedchorny RUO 02 has a microsensor integrated into the transfer catheter to measure the biomarker level in the uterine fluid entering the transfer catheter. Other patients' clinical variables and IVF cycle parameters (hormonal levels, ultrasound parameters, embryo quality grades, and transfer protocol) will also be collected.
Primary variable: Relationship between intrauterine dissolved biomarker concentration (alone or as a complex biological marker) and the outcome of the embryo transfer.
Notes: The intrauterine biomarker concentration is measured twice: the day before the transfer and on the transfer day. Complex biological marker refers to combining the concentration of the biomarker on both days and/or with other clinical variables of the patient/embryo.
The outcome of the embryo transfer is evaluated as:
Chemical pregnancy: positive pregnancy test (blood hGC detection); Clinical pregnancy confirmed by ultrasound at week six (detected gestational sac); Ongoing pregnancy at week eight, confirmed by ultrasound at week eight (detected gestational sac and heartbeat).
- Conditions
- Infertility
- Being tested
- Seedchrony
- Keywords
- embryo transfer, embryo implantation, endometrial preparation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeedchronyDevice
The seedchrony probe is coupled to the transfer catheter. When the transfer catheter is placed inside the uterus, the probe measures the biomarker concentraction in the fluid entering the catheter. The measurements last two minutes.
| Study group | Role | What they receive |
|---|---|---|
| Measurement | Experimental | Intrauterine biomarker will be measured twice in all enrolled patients during the frozen embryo transfer cycle: on the day before embryo transfer and on the day of embryo transfer. Receives: Device: Seedchrony |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrauterine biomarker concentration on the day before embryo transfer
The Seedchrony probe is coupled to the transfer catheter and placed in the uterine cavity. The probe measures the biomarker concentration in the fluid entering the catheter.
Measured: one day
Intrauterine biomarker concentration on the embryo transfer day
The Seedchrony probe is coupled to the transfer catheter and placed in the uterine cavity. The probe measures the biomarker concentration in the fluid entering the catheter.
Measured: one day
Secondary outcomes (5)
Biochemical Pregnancy
Biochemical Pregnancy outcome will be measured using a serum pregnancy test at 10-14 days after embryo transfer. Results will be record as positive or negative.
Measured: 10-14 days after embryo transfer
Clinical Pregnancy
Clinical Pregnancy outcome will be assessed by ultrasound at post-transfer week 4. Results will be record as positive or negative.
Measured: 4 weeks after embryo transfer
Ongoing Pregnancy
Ongoing Pregnancy outcome will be assessed by ultrasound at post-transfer week 6. Results will be record as positive or negative.
Measured: 6 weeks after embryo transfer
User experience and device safety in the clinical environment
End-user experience and feedback with clinicians' satisfaction questionnaire. Report of events regarding incorrect device handling, dropping, sensor breakage, erroneous readings, and device and software failures.
Measured: 12 months
Evaluate the patient's experience during measurements.
Visual Analog Scale (VAS) will be used to measure patients' pain and discomfort during measurements. Patients will be asked to rate their experience by making a mark along a line from 1 "no pain" to 10 "worst imaginable pain or discomfort". The distance from the starting point to the mark provides a quantitative measurement of the patient's experience.
Measured: two days (day before embryo transfer and on the transfer day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start28 Feb 2024
- Primary completion20 Dec 2025
- Study completion26 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manina Medtech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melchor Carbonell, Dr., Principal investigator, Hospital Universitario Vall d'Hebron Passeig de la Vall d'Hebron 119-129. 08035 Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259084
- Sponsor's protocol ID
- T-015-004
- Acronym
- Seedchrony02
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Detect the Predictive Capacity of a Composite Biological Marker in the Success of Embryonic Implantation in Fertilization Treatments In Vitro (IVF): Seedchrony Pilot.
- ClinicalTrials.gov ID
- NCT06259084
- Acronym / sponsor ID
- Seedchrony02 / T-015-004
- Conditions
- Infertility
- Keywords
- embryo transfer, embryo implantation, endometrial preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Manina MedtechIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitari Vall d'Hebron Research Institute
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 26 Apr 2026 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Vitro Fertilization (IVF) success is below 40%, with Embryo Transfer the leading cause of IVF failure. This clinical investigation aims to evaluate if the levels of an intrauterine biomarker dissolved in the uterine fluid (alone or as a complex biological marker) can predict the outcome of embryo transfer.
Detailed description
Seedchorny02 is an exploratory study, with blind evaluation by third parties, in a single center and without influencing clinical practice. The goal of this investigation is to evaluate if the levels of an intrauterine biomarker that is dissolved in the endometrial fluid can predict the outcome of embryo transfer, when measured the day before or on the day of embryo transfer.
80 IVF volunteers in a frozen embryo transfer cycle with high-quality day-five blastocysts are expected to be recruited. For intrauterine measurement, the investigational device Seedchrony RUO 02 will be used. Seedchorny RUO 02 has a microsensor integrated into the transfer catheter to measure the biomarker level in the uterine fluid entering the transfer catheter. Other patients' clinical variables and IVF cycle parameters (hormonal levels, ultrasound parameters, embryo quality grades, and transfer protocol) will also be collected.
Primary variable: Relationship between intrauterine dissolved biomarker concentration (alone or as a complex biological marker) and the outcome of the embryo transfer.
Notes: The intrauterine biomarker concentration is measured twice: the day before the transfer and on the transfer day. Complex biological marker refers to combining the concentration of the biomarker on both days and/or with other clinical variables of the patient/embryo.
The outcome of the embryo transfer is evaluated as:
Chemical pregnancy: positive pregnancy test (blood hGC detection); Clinical pregnancy confirmed by ultrasound at week six (detected gestational sac); Ongoing pregnancy at week eight, confirmed by ultrasound at week eight (detected gestational sac and heartbeat).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement | Experimental | Device: SeedchronyIntrauterine biomarker will be measured twice in all enrolled patients during the frozen embryo transfer cycle: on the day before embryo transfer and on the day of embryo transfer. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- First IVF cycle patients
- Patients who sign the informed consent form
- Patients between 18 and 37 years old.
- Patients BMI ≤ 30
- Patients who have frozen blastocysts of good quality (grade A or B)
Key exclusion criteria (6 listed)
- Patients with seminal data of the couple with severe oligozoospermia (sperm concentration <1 million sperm per ml) or azoospermia (absence of sperm in the ejaculate)
- Patients diagnosed with at least one of the following uterine pathologies: endometriosis, cancer, malformations, untreated polyps, or submucous fibroids.
- Patients diagnosed with at least one of the following medical pathologies: Polycystic ovary syndrome (PCOS), insulin-dependent diabetes mellitus, Cushing's syndrome, uncorrected thyroid dysfunction, hepatic and/or renal insufficiency, a pathology that contraindicates ovarian stimulation and/or gestation, antiphospholipid syndrome, and autoimmune disease.
- Patients who are currently taking any medication other than contraceptive treatments, which may interfere with fertility or menstrual cycle regulation.
- Evidence of drug, tobacco, or alcohol abuse or dependence according to medical history or information provided by the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeedchronyThe seedchrony probe is coupled to the transfer catheter. When the transfer catheter is placed inside the uterus, the probe measures the biomarker concentraction in the fluid entering the catheter. The measurements last two minutes. | Device | Measurement |
Primary outcome
Intrauterine biomarker concentration on the day before embryo transfer
Time frame: one day
The Seedchrony probe is coupled to the transfer catheter and placed in the uterine cavity. The probe measures the biomarker concentration in the fluid entering the catheter.
Intrauterine biomarker concentration on the embryo transfer day
Time frame: one day
The Seedchrony probe is coupled to the transfer catheter and placed in the uterine cavity. The probe measures the biomarker concentration in the fluid entering the catheter.
5 secondary outcomes
Biochemical Pregnancy
Time frame: 10-14 days after embryo transfer
Clinical Pregnancy
Time frame: 4 weeks after embryo transfer
Ongoing Pregnancy
Time frame: 6 weeks after embryo transfer
User experience and device safety in the clinical environment
Time frame: 12 months
Evaluate the patient's experience during measurements.
Time frame: two days (day before embryo transfer and on the transfer day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melchor Carbonell, Dr. principal investigator
Hospital Universitario Vall d'Hebron Passeig de la Vall d'Hebron 119-129. 08035 Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seedchrony in people with Infertility, run by Manina Medtech at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrauterine biomarker concentration on the day before embryo transfer (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.