EndometriumEMBeDNCT04906551
Measuring Endometrial Blood Flow Using Laser Doppler: Acceptability & Reproducibility
An observational study of Endometrium and Vascularization, run by Birmingham Women's and Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
35 participants will be recruited from a list of patients who are scheduled, as part of their routine NHS care, to have a clinically-indicated outpatient hysteroscopy for assessment of their uterine cavity. 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, Vascularization
- What is being tested?
- laser Doppler
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jun 2021to 6 Jun 2022
- How long will I take part?
- 1 Year
- 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: Women from the age of 18 up to the age of 40 who have consented to hysteroscopy investigation as part of their standard NHS care.
Who may be able to join
- Women from the age of 18 up to the age of 40 who have consented to hysteroscopy investigation as part of their standard NHS care.
- Women who have had an ultrasound scan, within the preceding 5 years, demonstrating a normal uterine cavity with no gross anatomical abnormalities (e.g. uterine septum).
- Women who have given informed consented to take part in the study
Who cannot join
- Inability to tolerate vaginal examinations
- Women who are pregnant
- Women who do not have regular menstrual cycles
- Women who have not given consent to the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
BWC
Birmingham, B4 6NH
Liz Adey, e.adey@nhs.net
Sarah Hadfield, sarah.hadfield2@nhs.net
About this study
35 participants will be recruited from a list of patients who are scheduled, as part of their routine NHS care, to have a clinically-indicated outpatient hysteroscopy for assessment of their uterine cavity. The participants will be women from the age of 18 up to the age of 40 who are undergoing hysteroscopy investigation. All participants included in the study require at least one ultrasound scan, within the preceding 5 years, demonstrating the presence of a normal uterine cavity devoid of uterine anomalies such as a septate uterus or intrauterine fibroids (which may affect endometrial blood flow measurements). It is usual for a patients to have an ultrasound assessment prior to hysteroscopy therefore we do not anticipate this requirement limiting the number of eligible participants available.
Read the detailed description
Patient registry: Recruited patients will be registered on 'Edge', a secure, password-protected, database for study participants.
All the investigators will comply with the requirements of the GDPR 2018 with regards to the storage, processing and disclosure of personal information and will uphold the Act's core principles.
Access to patient-identifiable data will be restricted to the core patient-facing members of the research team at Birmingham Women's and Children's Hospital. The patient-facing members will be the Chief Investigator (ME), the Principal Investigator (JC), and co-investigator (HH).
The study involves depersonalised data and the data will be maintained within secure servers. The Birmingham Women's Hospital Research and Development department will hold an archived copy of the study data.
The Chief Investigator (ME) and the Principal Investigator (JC) will act as data custodians and keep the site file locked away securely with restricted access to study data for 25 years. Only the aforementioned members of the research team will have access to the site file for the purpose of quality control, audit and analysis.
Coded, depersonalised data will be created and used for study documents, in place of participant-identifying information. The participant data within the study and the code linking this data to the individual's true identity and identifiable data will be kept in separate locations using encrypted digital files within password-protected folders and storage media
- Conditions
- Endometrium, Vascularization
- Being tested
- laser Doppler
- Medical subject headings
- Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser DopplerDevice
A direct measure of blood flow
What is being measured
The primary outcome is the main question the study is designed to answer.
The intra-operator variability
The intra-operator variability of the 3 endometrial blood flow values taken for each participant, by a given operator.
Measured: 1 minute
The inter-operator variability
The inter-operator variability, standard deviation, standard error and the variability of measurements taken between participants.
Measured: 1 minute
Secondary outcomes (1)
Participant acceptability
Participant acceptability of undergoing laser Doppler measurement of endometrial tissue blood flow
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start7 Jun 2021
- Primary completion6 Jun 2022 (estimated)
- Study completion6 Jun 2022 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Eyo, Birmingham Women's and Children's NHS Foundation Trust
- Investigators
- Mary Eyo, Principal investigator, Birmingham Women's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906551
- Sponsor's protocol ID
- 250444
- Acronym
- EMBeD
- Status last verified
- Aug 2021
- First submitted
- 25 May 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Endometrial Blood Flow Using Laser Doppler: Acceptability & Reproducibility
- ClinicalTrials.gov ID
- NCT04906551
- Acronym / sponsor ID
- EMBeD / 250444
- Conditions
- Endometrium, Vascularization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 6 Jun 2022 (estimated)
- Study completion
- 6 Jun 2022 (estimated)
- First posted
- 28 May 2021 (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.
35 participants will be recruited from a list of patients who are scheduled, as part of their routine NHS care, to have a clinically-indicated outpatient hysteroscopy for assessment of their uterine cavity. The participants will be women from the age of 18 up to the age of 40 who are undergoing hysteroscopy investigation. All participants included in the study require at least one ultrasound scan, within the preceding 5 years, demonstrating the presence of a normal uterine cavity devoid of uterine anomalies such as a septate uterus or intrauterine fibroids (which may affect endometrial blood flow measurements). It is usual for a patients to have an ultrasound assessment prior to hysteroscopy therefore we do not anticipate this requirement limiting the number of eligible participants available.
Detailed description
Patient registry: Recruited patients will be registered on 'Edge', a secure, password-protected, database for study participants.
All the investigators will comply with the requirements of the GDPR 2018 with regards to the storage, processing and disclosure of personal information and will uphold the Act's core principles.
Access to patient-identifiable data will be restricted to the core patient-facing members of the research team at Birmingham Women's and Children's Hospital. The patient-facing members will be the Chief Investigator (ME), the Principal Investigator (JC), and co-investigator (HH).
The study involves depersonalised data and the data will be maintained within secure servers. The Birmingham Women's Hospital Research and Development department will hold an archived copy of the study data.
The Chief Investigator (ME) and the Principal Investigator (JC) will act as data custodians and keep the site file locked away securely with restricted access to study data for 25 years. Only the aforementioned members of the research team will have access to the site file for the purpose of quality control, audit and analysis.
Coded, depersonalised data will be created and used for study documents, in place of participant-identifying information. The participant data within the study and the code linking this data to the individual's true identity and identifiable data will be kept in separate locations using encrypted digital files within password-protected folders and storage media
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women from the age of 18 up to the age of 40 who have consented to hysteroscopy investigation as part of their standard NHS care.
Key inclusion criteria (3 listed)
- Women from the age of 18 up to the age of 40 who have consented to hysteroscopy investigation as part of their standard NHS care.
- Women who have had an ultrasound scan, within the preceding 5 years, demonstrating a normal uterine cavity with no gross anatomical abnormalities (e.g. uterine septum).
- Women who have given informed consented to take part in the study
Key exclusion criteria (4 listed)
- Inability to tolerate vaginal examinations
- Women who are pregnant
- Women who do not have regular menstrual cycles
- Women who have not given consent to the study.
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 |
|---|---|---|
| laser DopplerA direct measure of blood flow | Device | – |
Primary outcome
The intra-operator variability
Time frame: 1 minute
The intra-operator variability of the 3 endometrial blood flow values taken for each participant, by a given operator.
The inter-operator variability
Time frame: 1 minute
The inter-operator variability, standard deviation, standard error and the variability of measurements taken between participants.
1 secondary outcome
Participant acceptability
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Mary Eyo principal investigator
Birmingham Women's NHS Foundation Trust
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 Endometrium and Vascularization, run by Birmingham Women's and Children's NHS Foundation Trust at 1 site in United Kingdom.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Aug 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Hadfield (0121 472 1377, sarah.hadfield2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intra-operator variability (time frame: 1 minute). The study lists 2 primary outcomes in all. 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 Aug 2021.