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

NCT06259084 | Recruiting DMC

• 1 other identifier: T-015-004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

embryo transfer; embryo implantation; endometrial preparation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Biochemical Pregnancy

  10-14 days after embryo transfer

• Clinical Pregnancy

  4 weeks after embryo transfer

• Ongoing Pregnancy

  6 weeks after embryo transfer

• User experience and device safety in the clinical environment

  12 months

• Evaluate the patient's experience during measurements.

  two days (day before embryo transfer and on the transfer day)

Study Arms (1)

Measurement

EXPERIMENTAL

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

Interventions

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.

Measurement

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manina Medtech: lead
• Hospital Universitari Vall d'Hebron Research Institute: collaborator

Study Sites (1)

Vall d'Hebron Hospital

Barcelona, Other (Non US), 08035, Spain

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Melchor Carbonell, Dr.

  Hospital Universitario Vall d'Hebron Passeig de la Vall d'Hebron 119-129. 08035 Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Rodriguez de la Vega, PhD

CONTACT

+34 934764928; monica.delavega@maninamedtech.com

Luis Artiles, PhD

CONTACT

+34 934764928; vigilancia@maninamedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 14, 2024
• Study Start: February 28, 2024
• Primary Completion: June 5, 2025
• Study Completion: July 5, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)