Implantation test for endometrial receptivity v1.0
Research type
Research Study
Full title
Implantation test for endometrial receptivity
IRAS ID
233994
Contact name
Laurentiu Craciunas
Contact email
Sponsor organisation
University of Birmingham
Clinicaltrials.gov Identifier
Local Research Support Group, ERN_17-1228
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Background
Miscarriage is the most frequent complication of pregnancy and represents the spontaneous loss of the embryo or foetus before it is able to survive independently (24 weeks of gestation). It affects up to 50% of pregnancies with the vast majority (80%) occurring at pre-clinical stage before the woman recognises the pregnancy. Up to 5% of couples suffer recurrent miscarriage defined as 2-3 or more miscarriages leading to physical, emotional and financial consequences for couples, doctors and medical systems.
Different maternal health problems (thyroid disease, sticky blood, autoimmune disease, anatomical anomalies of the womb) and embryo defects may be responsible for some of the miscarriages; however, more than 50% of the occurrences have no identifiable cause based on the current diagnostic tests.Aim
The aim of the present research proposal is to understand the role of the lining of the womb in miscarriage and to explore the development of a potential implantation test that is cost-effective and may be implemented in clinical practice.Methods
Over a period of two years, women who suffered recurrent miscarriage will be approached in the advanced miscarriage clinic at Birmingham Women’s Hospital during their routine appointment. They will be invited to participate by undergoing chromohysteroscopy and/or a biopsy from the lining of the womb during an outpatient appointment.
Chromohysteroscopy is based on a routine hysteroscopy which involves visualising the inside of the womb using a narrow telescope passed through the neck of the womb (cervix). “Chromo” comes from the fact that an iodine based dye will be injected to increase the power of the test.
The biopsy will be taken using a narrow plastic tube passed through the cervix. It is a standard diagnostic test for women with abnormal bleeding. As part of the present research, different cells and molecules will be analysed from the biopsy sample.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
17/WM/0382
Date of REC Opinion
30 Oct 2017
REC opinion
Further Information Favourable Opinion