Infertility, FemaleFERTIGO®NCT05440019
Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
An observational study of Infertility, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- IMAGE CAPTURE SESSION
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 14 Sep 2022to 26 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: The target population includes healthy women between 18 and 40 years with regular menstrual cycles.
Who may be able to join
- Healthy women
- Age: 18 - 40, both inclusive
- Regular menstrual cycles
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Infertility, Female
- Being tested
- IMAGE CAPTURE SESSION
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMAGE CAPTURE SESSIONDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HEALTHY WOMEN IVI VALENCIA | 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. Receives: Device: IMAGE CAPTURE SESSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (2)
To evaluate the captured image quality (calibration)
Measure the image quality.
Measured: 1 month
To know the opinion/level of satisfaction of the study participants
Measure the satisfaction level of participants using questionaries
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start14 Sep 2022
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440019
- Sponsor's protocol ID
- 2010-VLC-086-FC
- Acronym
- FERTIGO®
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decided jet
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Usability of the M3T FERTIGO® System and Its Calibration
- ClinicalTrials.gov ID
- NCT05440019
- Acronym / sponsor ID
- FERTIGO® / 2010-VLC-086-FC
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEALTHY WOMEN IVI VALENCIA | – | Device: IMAGE CAPTURE SESSIONParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The target population includes healthy women between 18 and 40 years with regular menstrual cycles.
Key inclusion criteria (3 listed)
- Healthy women
- Age: 18 - 40, both inclusive
- Regular menstrual cycles
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMAGE CAPTURE SESSIONThe 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. | Device | HEALTHY WOMEN IVI VALENCIA |
Primary outcome
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
2 secondary outcomes
To evaluate the captured image quality (calibration)
Time frame: 1 month
To know the opinion/level of satisfaction of the study participants
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: Undecided. No decided jet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and usability of the M3T for endometrium image capture (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.