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Completed

NCT Number: NCT06259084

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

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.

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Key information

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vall d'Hebron Hospital

Barcelona, Other (Non US), 08035, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Not having had a previous embryo transfer.
  • 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.

Treatment and study plan

Seedchrony

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Manina Medtech

Industry

Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Registry information

Official study 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.

Acronym: Seedchrony02

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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