Chronic endometritis and unexplained recurrent miscarriage, version 1
Research type
Research Study
Full title
The CHronic endometritis ANd unexplained reCurrent miscarriagE (CHANCE) Study: the role of the endometrial microbiome
IRAS ID
266373
Contact name
Islam Gamaleldin
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Background: Many people want to become parents. Unfortunately, 5% of couples experience recurrent miscarriage (RM) – defined as two or more miscarriages in a row. In more than half of these cases no cause is found. This has a significant psychological impact on couples and uses many NHS resources. We do not know how to treat women with unexplained RM and currently only offer supportive care.
A suggested cause of RM is persistent inflammation of the womb lining. This is known as ‘chronic endometritis’. It may result in an unhealthy environment for an embryo. Chronic endometritis cannot be detected using regular tests; it requires examining a sample of the womb lining in a laboratory.
Aim: To identify whether women with RM are more likely to have chronic endometritis than women without RM, and to identify any bacteria that might be responsible for chronic endometritis. Furthermore, we will investigate if RM could be caused by changing the distribution/function of cells in the womb lining as a result of chronic endometritis.
Methods: This study will take place in Southmead Hospital, Bristol. We will collect a sample of the womb lining from 100 women with a history of RM and from 100 women who have had a successful pregnancy and no history of RM (a control group). The control group will be women undergoing planned “key hole” surgery for another reason but which allows easy sampling of their womb lining too. If our study shows that chronic endometritis is a likely cause of RM, we will carry out another study to see if treating chronic endometritis, with targeted antibiotics, increases pregnancy rates. Effective treatment would improve outcomes for our patients and save the NHS and society costs associated with RM.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
19/EM/0229
Date of REC Opinion
9 Sep 2019
REC opinion
Further Information Favourable Opinion