Clinical trial NCT05440019: Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
Official title: Evaluation of the Safety and Usability of the M3T FERTIGO® System and Its Calibration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population includes healthy women between 18 and 40 years with regular menstrual cycles.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the safety and usability of the M3T for endometrium image capture
timeFrame: 1 month
Secondary outcomes:
measure: To evaluate the captured image quality (calibration)
timeFrame: 1 month
measure: To know the opinion/level of satisfaction of the study participants
timeFrame: 1 month
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ivi Valencia
Study officials:
References: