Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration (FERTIGO®)

Evaluation of the Safety and Usability of the M3T FERTIGO® System and Its Calibration

We have developed a new minimally invasive system for endometrial dating, that allows the physician to monitor, capture, project and analyze the actual morphology and maturity of the endometrial surface, at any given time. A time series of such indications provides an assessment regarding the pace of development by which the endometrium is maturing during a relevant cycle.

FERTIGO®'s method for endometrial dating has been validated in swine and ex-vivo human samples, where image analysis of tissues has been compared with traditional endometrial dating techniques. The comparison yielded calibration means and correlation between FERTIGO®'s dating and the traditional dating methods.

Thus, M3T FERTIGO®'s system is designed to enable the determination of the actual physiological cycle date, in good correlation with the indirect (endometrial thickness and hormones level) and delayed known methods (histopathology). To this end, a high quality, low magnification (X2-X4) image of the endometrium surface should be acquired, stored and analyzed.

This trial will evaluate, on the one hand, the safety and usability of the FERTIGO® device and, on the other hand, calibrate it by evaluating image quality. Both safety and usability will be measured through questionnaires answered by the participants (adverse events and satisfaction) and by the physicians (satisfaction), respectively, considering the introduction of the device, its use, and its removal.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Device: IMAGE CAPTURE SESSION

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

• Study Contact: Name: LAURA CARACENA, Mrs.; Phone Number: 11054 034 963.050.900; Email: laura.caracena@ivirma.com
• Study Contact Backup: Name: Ana Saez, Mrs.; Phone Number: 4090 034 963.050.300; Email: ana.saez@ivirma.com

Study Locations

• Spain
  • Valencia, Spain, 46015
    • IVI Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The target population includes healthy women between 18 and 40 years with regular menstrual cycles.

Description

Inclusion criteria:

1. Healthy women
2. Age: 18 - 40, both inclusive
3. Regular menstrual cycles

Exclusion criteria:

1. Simultaneous participation in another clinical study that, at researcher's criteria, could interfere with the results of this study
2. Current pregnancy
3. Women with known existing endometrial pathology
4. Women with known oligo-ovulation or un-ovulation.
5. Women who were diagnosed with Endometriosis or Adenomyosis
6. Women with medical history of malignant tumors in their reproductive system
7. Women with IUD in place
8. Women menstruating on the day of the procedure
9. Women who have signs and symptoms of PID
10. Women who currently use any hormonal medications.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

HEALTHY WOMEN IVI VALENCIA; Participants will be exposed to four sessions of image captures using FERTIGO® device. Prior to the session, a vaginal ultrasound (US) will be performed, for measuring the endometrial thickness as in the usual practice.

Device: IMAGE CAPTURE SESSION; The M3T FERTIGO® is an instrument to be used by a certified gynecologist and in particular by an IVF expert physician in order to observe and monitor the state of the endometrium lining of patients. The M3T device serves as a "mini hysteroscope" capable of magnification, capturing images and optional image processing thereof. The M3T enables to acquire in-vivo, magnified images of the endometrium surface, to identify key morphological parameters, calculate their attributes and statistics thereof and compare those for different acquisition images and to some "standard" tissue state tracks. One may then attempt to predict the Embryo transfer optimal timing, based on this analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and usability of the M3T for endometrium image capture	Measure of frequency and severity of all treatment-related adverse events, and physicians' satisfaction questionnaire	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the captured image quality (calibration)	Measure the image quality.	1 month
To know the opinion/level of satisfaction of the study participants	Measure the satisfaction level of participants using questionaries	1 month

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: 2010-VLC-086-FC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No decided jet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No