Uterine Bleeding and Endometrial Function
Research type
Research Study
Full title
Understanding local mechanisms involved in uterine bleeding and endometrial function (PEtAL)
IRAS ID
268671
Contact name
Hilary Critchley
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 3 months, 31 days
Research summary
Abnormal uterine bleeding (AUB) is a condition where a woman's monthly menstrual blood loss (MBL) changes in amount/frequency of the bleed, often becoming heavier and/or more frequent. This debilitating condition affects 25% of all women before the menopause and significantly impacts them socially, mentally and financially. The mechanisms which cause the lining of the womb (endometrium) to bleed abnormally are not yet known, but may relate to “progesterone resistance” i.e. the endometrium has an altered response to progesterone. This means treatment options are not specific, leading almost a third of patients to resort to major surgery to remove the womb.
This study forms the human part of a national/international collaboration to understand uterine bleeding and endometrial function. It aims to investigate tissue samples from women with AUB. Recruitment will occur from gynaecology services within NHS Lothian. Tissue samples are routinely collected as part of standard clinical care during the investigation/treatment of patients. The majority of samples will therefore be surplus tissue to what is needed for clinical diagnosis. Groups of patients will be carefully categorised according to cause of AUB, e.g. fibroids, adenomyosis and the impact of age. To corroborate this categorisation, objective measurements of MBL may be taken in some women.
Laboratory tests (cellular/molecular) will be conducted at the MRC Centre for Reproductive Health (University of Edinburgh). Tests will aim to understand if the endometrium is different in women with AUB, the impact of age and if there are signs of progesterone resistance. Testing will also investigate if treatments can be better targeted in the future, providing a better outcome for women, improving quality of life and reducing the need for surgery.
Anonymised data will be shared between national/international collaborators as part of the analyses of this study. This study will take approximately five years to complete.REC name
South East Scotland REC 02
REC reference
19/SS/0102
Date of REC Opinion
25 Oct 2019
REC opinion
Further Information Favourable Opinion