EndometriumNCT04288843
Endometrial Dating by Ex-vivo Imaging of Endometrial Biopsies of In-vitro Fertilization Candidate Participants
An observational study of Endometrium, run by Fertigo Medical Ltd at 2 sites in Israel.
Trial summary
To evaluate the correlation between cycle day determination by clinical signs, study participant testimony, endometrium histopathology biopsy and ex-vivo imaging of the uterus endometrium. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrium
- How many people
- 49 participants
- Where
- 2 sitesIsrael
- Study dates
- 16 Jun 2019to 6 Jun 2021
- 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
- Healthy volunteers accepted
- Adult
Study population: The study will include up to 200 women between the ages of 18 - 40, to be recruited from the general population and medical center patient population, after determination that they are suited to the study according to the inclusion/exclusion criteria, and after having given informed consent to participate in the study. The sample size of the study will be determined such that adequate mapping of the 24 days of the menstrual cycle (putting more weight on luteal phase), excluding menstruation days (assuming a 28 day cycle), and dividing of the cohort into subgroups by age, can be achieved using the study methods described below, while adhering to financial constraints.
Who may be able to join
- Gender: Female
- Age: 18-40
- Belong to one of the three following groups:
- Women undergoing fertility treatment, and are regularly ovulating
- Women whose fertility status is unknown
- Women proved to be fertile (previous spontaneous successful pregnancy)
Who cannot join
- Women with known existing endometrial pathology
- Women with known history of infertility due to oligo-ovulation or anovulation.
- Women with medical history of malignant tumors in their reproductive system
- Women that are on any hormonal medications or treatments (excluding hormonal contraception in previous cycles)
- Women that are on hormonal contraception treatment in their current cycle
- Women with intrauterine device
- Women menstruating on the day of the biopsy collection
Trial locations and contacts
2 sites in 1 country.
About this study
To evaluate the correlation between cycle day determination by clinical signs, study participant testimony, endometrium histopathology biopsy and ex-vivo imaging of the uterus endometrium.
Read the detailed description
In order to assess the efficacy of using ex-vivo endometrial imaging to determine optimal time for embryo transfer, two to four separate analyses, including imaging, and the current standard method of endometrial dating (ultrasound, histological and blood tests) will be performed as well as participant's testimony. Dating by hormonal profile (blood tests) will be contingent on availability of the tests for each subject. So shall be the ultrasound test. During the analysis data will be acquired for subsequent correlation analysis. In addition, a parallel in-vivo analysis, similar in methodology to the ex-vivo analysis, may be performed via imaging by hysteroscopy.
- Conditions
- Endometrium
- Keywords
- Endometrial dating
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between image-based endometrial dating and that of histology
Correlation coefficients and/or P-value levels
Measured: 12 months
Secondary outcomes (1)
Correlation between image-based endometrial dating and other collected data
Collected data: hormonal profile, ultrasound images, subject self-reporting of cycle date
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start16 Jun 2019
- Primary completion31 Dec 2020
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriumStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fertigo Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaplan Medical Center
- Responsible party
- Sponsor
- Investigators
- Tsafrir S Kolatt, Ph.D., Study chair, Fertigo Medical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288843
- Sponsor's protocol ID
- FER-CT-001
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Dating by Ex-vivo Imaging of Endometrial Biopsies of In-vitro Fertilization Candidate Participants
- ClinicalTrials.gov ID
- NCT04288843
- Acronym / sponsor ID
- FER-CT-001
- Conditions
- Endometrium
- Keywords
- Endometrial dating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Fertigo Medical LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kaplan Medical Center
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 28 Feb 2020 (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.
To evaluate the correlation between cycle day determination by clinical signs, study participant testimony, endometrium histopathology biopsy and ex-vivo imaging of the uterus endometrium.
Detailed description
In order to assess the efficacy of using ex-vivo endometrial imaging to determine optimal time for embryo transfer, two to four separate analyses, including imaging, and the current standard method of endometrial dating (ultrasound, histological and blood tests) will be performed as well as participant's testimony. Dating by hormonal profile (blood tests) will be contingent on availability of the tests for each subject. So shall be the ultrasound test. During the analysis data will be acquired for subsequent correlation analysis. In addition, a parallel in-vivo analysis, similar in methodology to the ex-vivo analysis, may be performed via imaging by hysteroscopy.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include up to 200 women between the ages of 18 - 40, to be recruited from the general population and medical center patient population, after determination that they are suited to the study according to the inclusion/exclusion criteria, and after having given informed consent to participate in the study. The sample size of the study will be determined such that adequate mapping of the 24 days of the menstrual cycle (putting more weight on luteal phase), excluding menstruation days (assuming a 28 day cycle), and dividing of the cohort into subgroups by age, can be achieved using the study methods described below, while adhering to financial constraints.
Key inclusion criteria (6 listed)
- Gender: Female
- Age: 18-40
- Belong to one of the three following groups:
Key exclusion criteria (7 listed)
- Women with known existing endometrial pathology
- Women with known history of infertility due to oligo-ovulation or anovulation.
- Women with medical history of malignant tumors in their reproductive system
- Women that are on any hormonal medications or treatments (excluding hormonal contraception in previous cycles)
- Women that are on hormonal contraception treatment in their current cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between image-based endometrial dating and that of histology
Time frame: 12 months
Correlation coefficients and/or P-value levels
1 secondary outcome
Correlation between image-based endometrial dating and other collected data
Time frame: 12 months
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 23 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingObservational study
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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.
Tsafrir S Kolatt, Ph.D. study chair
Fertigo Medical Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrium, run by Fertigo Medical Ltd at 2 sites in Israel.
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 6 inclusion and 7 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Correlation between image-based endometrial dating and that of histology (time frame: 12 months). 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 23 Feb 2024.