Study to Estimate Seedchrony's Predictive Capacity in the Success of Embryo Implantation.
NCT ID: NCT06259084
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-02-28
2025-07-05
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
37 Years
FEMALE
Yes
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Manina Medtech
INDUSTRY
Responsible Party
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Principal Investigators
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Melchor Carbonell, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Vall d'Hebron Passeig de la Vall d'Hebron 119-129. 08035 Barcelona
Locations
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Vall d'Hebron Hospital
Barcelona, Other (Non US), Spain
Countries
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Central Contacts
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Facility Contacts
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Melchor Carbonell, Ph.D.
Role: backup
Anna Teixido, MD
Role: backup
Julio Herrero, PhD
Role: backup
Other Identifiers
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T-015-004
Identifier Type: -
Identifier Source: org_study_id