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

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05440019
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Device: IMAGE CAPTURE SESSION

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the Safety and Usability of the M3T FERTIGO® System and Its Calibration
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. To evaluate the safety and usability of the M3T for endometrium image capture [1 month]

   Measure of frequency and severity of all treatment-related adverse events, and physicians' satisfaction questionnaire

Secondary Outcome Measures

1. To evaluate the captured image quality (calibration) [1 month]

   Measure the image quality.

2. To know the opinion/level of satisfaction of the study participants [1 month]

   Measure the satisfaction level of participants using questionaries

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ivi Valencia	Valencia		Spain	46015

Sponsors and Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Instituto Valenciano de Infertilidad, IVI VALENCIA
• ClinicalTrials.gov Identifier: NCT05440019
• Other Study ID Numbers: 2010-VLC-086-FC
• First Posted: Jun 30, 2022
• Last Update Posted: Jul 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Infertility, Female

Study Results

No Results Posted as of Jul 6, 2022