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

Infertility Clinical Trial

— Seedchrony02  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06259084
• Other study ID #: T-015-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: April 5, 2025

Study information

• Verified date: February 2024
• Source: Manina Medtech
• Contact: Monica Rodriguez de la Vega, PhD
• Phone: +34 934764928
• Email: vigilancia[@]maninamedtech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 5, 2025
• Est. primary completion date: February 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• First IVF cycle patients
• Patients who sign the informed consent form
• Patients between 18 and 35 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.

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Manina Medtech	Hospital Universitari Vall d'Hebron Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one day
Primary	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.	one day
Secondary	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.	10-14 days after embryo transfer
Secondary	Clinical Pregnancy	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
Secondary	Ongoing Pregnancy	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
Secondary	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.	12 months
Secondary	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.	two days (day before embryo transfer and on the transfer day)