Clinical trial NCT04906551: Measuring Endometrial Blood Flow Using Laser Doppler: Acceptability & Reproducibility
Official title: Measuring Endometrial Blood Flow Using Laser Doppler: Acceptability & Reproducibility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrium
Vascularization
Lead sponsor: Birmingham Women's and Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The intra-operator variability
timeFrame: 1 minute
measure: The inter-operator variability
timeFrame: 1 minute
Secondary outcomes:
measure: Participant acceptability
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: BWC
Study officials:
affiliation: Birmingham Women's NHS Foundation Trust
name: Mary Eyo
role: PRINCIPAL_INVESTIGATOR
References: