Study to Estimate Seedchrony's Predictive Capacity in the Success of Embryo Implantation. (Seedchrony02)

June 1, 2026 updated by: Manina Medtech

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Other (Non US)
      • Barcelona, Other (Non US), Spain, 08035
        • Vall d'Hebron Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • 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:

    1. Not having had a previous embryo transfer.
    2. Have failed only one embryo transfer

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measurement
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.
Device: Seedchrony
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one day
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.
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Pregnancy
Time Frame: 10-14 days after embryo transfer
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.
10-14 days after embryo transfer
Clinical Pregnancy
Time Frame: 4 weeks after embryo transfer
Clinical Pregnancy outcome will be assessed by ultrasound at post-transfer week 4. Results will be record as positive or negative.
4 weeks after embryo transfer
Ongoing Pregnancy
Time Frame: 6 weeks after embryo transfer
Ongoing Pregnancy outcome will be assessed by ultrasound at post-transfer week 6. Results will be record as positive or negative.
6 weeks after embryo transfer
User experience and device safety in the clinical environment
Time Frame: 12 months
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.
12 months
Evaluate the patient's experience during measurements.
Time Frame: two days (day before embryo transfer and on the transfer day)
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.
two days (day before embryo transfer and on the transfer day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manina Medtech

Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Melchor Carbonell, Dr., Hospital Universitario Vall d'Hebron Passeig de la Vall d'Hebron 119-129. 08035 Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Actual)

December 20, 2025

Study Completion (Actual)

April 26, 2026

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-015-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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