Measuring Endometrial Blood Flow Using Laser Doppler: Acceptability & Reproducibility

NCT04906551 | Unknown DMC

• 1 other identifier: 250444
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometrium; Vascularization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Participant acceptability

  5 minutes

Interventions

laser Doppler DEVICE

A direct measure of blood flow

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust: lead

Study Sites (1)

BWC

Birmingham, B4 6NH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neovascularization, Pathologic

Interventions

Laser-Doppler Flowmetry

Condition Hierarchy (Ancestors)

Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Rheology; Investigative Techniques

Study Officials

• Mary Eyo

  Birmingham Women's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Hadfield

CONTACT

0121 472 1377; sarah.hadfield2@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: June 7, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)