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Completed

NCT Number: NCT05440019

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Ivi Valencia

Valencia, 46015, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy women
  • Age: 18 - 40, both inclusive
  • Regular menstrual cycles

Exclusion criteria

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

Treatment and study plan

IMAGE CAPTURE SESSION

Device

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.

Primary outcomes

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

    Time frame: 1 month

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

Secondary outcomes

  1. To evaluate the captured image quality (calibration)

    Time frame: 1 month

    Measure the image quality.

  2. To know the opinion/level of satisfaction of the study participants

    Time frame: 1 month

    Measure the satisfaction level of participants using questionaries

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study title

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

Acronym: FERTIGO®

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 30, 2022
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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