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NCT05440019: FERTIGO®

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

Completed Last updated 24 October 2023
What this trial tests

trial testing IMAGE CAPTURE SESSION in Infertility, Female in 20 participants. Completed in 26 April 2023.

Timeline
14 September 2022
Primary endpoint
26 April 2023
26 April 2023

Quick facts

Lead sponsorInstituto Valenciano de Infertilidad, IVI VALENCIA
StatusCompleted
Study typeOBSERVATIONAL
Enrollment20
Start date14 September 2022
Primary completion26 April 2023
Estimated completion26 April 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA — full company profile →

Who can join

Adults 18 to 40, female only, with Infertility, Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Infertility, Female

Currently open trials in the same condition.

Other Instituto Valenciano de Infertilidad, IVI VALENCIA trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05440019.

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