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NCT05440019: FERTIGO®
Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
trial testing IMAGE CAPTURE SESSION in Infertility, Female in 20 participants. Completed in 26 April 2023.
26 April 2023
Quick facts
| Lead sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 14 September 2022 |
| Primary completion | 26 April 2023 |
| Estimated completion | 26 April 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- IMAGE CAPTURE SESSION
Conditions studied
- Infertility, Female — all drugs for Infertility, Female →
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.
Verify or expand the search:
- PubMed search for NCT05440019
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Instituto Valenciano de Infertilidad, IVI VALENCIA trials
Trials by the same sponsor.
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- NCT05184777 — Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05440019 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto Valenciano de Infertilidad, IVI VALENCIA
- Last refreshed: 24 October 2023
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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