Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility, Female

Intervention / Treatment
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* Device: IMAGE CAPTURE SESSION


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HEALTHY WOMEN IVI VALENCIA<br>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<br>* 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.<br>|

What is the study measuring?
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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 |