Measuring Endometrial Blood Flow Using Laser Doppler: Acceptability & Reproducibility (EMBeD)

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrium; Vascularization
• Intervention / Treatment: Device: laser Doppler

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 Type: Observational
• Enrollment (Anticipated): 35

Contacts and Locations

• Study Contact: Name: Sarah Hadfield; Phone Number: 0121 472 1377; Email: sarah.hadfield2@nhs.net

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Recruiting
    • BWC
    • Contact: Liz Adey; Email: e.adey@nhs.net
    • Contact: Sarah Hadfield; Email: sarah.hadfield2@nhs.net
    • Principal Investigator: Mary Eyo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The intra-operator variability	The intra-operator variability of the 3 endometrial blood flow values taken for each participant, by a given operator.	1 minute
The inter-operator variability	The inter-operator variability, standard deviation, standard error and the variability of measurements taken between participants.	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant acceptability	Participant acceptability of undergoing laser Doppler measurement of endometrial tissue blood flow	5 minutes

Collaborators and Investigators

• Sponsor: Birmingham Women's and Children's NHS Foundation Trust
• Investigators: Principal Investigator: Mary Eyo, Birmingham Women's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2021
• Primary Completion (ANTICIPATED): June 6, 2022
• Study Completion (ANTICIPATED): June 6, 2022

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (ACTUAL): May 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Neovascularization, Pathologic
• Other Study ID Numbers: 250444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No