RecruitingNot ApplicableNCT06259084

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

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.

Sponsor

Manina Medtech

Enrollment

80 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

Infertility

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 37 Years

Inclusion Criteria11

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 Criteria6

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.

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Interventions

DEVICESeedchrony

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.