A multicentre randomised controlled trial of induced endometrial trauma in women undergoing first time In Vitro Fertilisation (IVF)

Record ID 32015001234
English
Authors' objectives: Taking a small amount of tissue from the lining of the womb (endometrium) can sometimes improve the chance of achieving a pregnancy in women who have previously had several unsuccessful attempts at In Vitro Fertilisation (IVF). This procedure has been named endometrial scratch (ES). It is not known exactly why performing an Endometrial Scratch may be beneficial, but it is thought that the process of scratching the lining of the womb may release certain chemicals that are important in helping the fertilised egg (embryo) stick to the lining of the womb (implantation). The use of Endometrial Scratch has not yet been fully tried in women who are about to have IVF for the first time. If found to be beneficial then it could be used to improve the chance of achieving a pregnancy for a large group of women without the need for repeated IVF attempts. Our study aims to explore the use of performing an Endoemtrial Scratch in younger women (37yrs of age or younger) about to start their first IVF treatment cycle. The study will involve 1044 participants over the course of two & half years. Women taking part in the study will be selected to have either the scratch or not in a random way (like a tossing a coin) so each woman would have a 50/50 chance of having the scratch procedure. Those having the scratch would be known as the study group and those who do not the control group . Both groups would then have their IVF treatment in the usual way and would be followed up to see whether or not they get pregnant and have a healthy baby. Except for one extra visit when the scratch is performed, the study does not involve any other visits or treatments above normal routine care. Participation in this study will be entirely voluntary and the choice not to participate would not have any impact on the woman s care. Performing the emdometrial scratch is a very simple routine outpatient procedure that does not require any anaesthetic. Women are advised to take some simple painkillers beforehand (such as paracetamol) as these should lessen the chance of any discomfort as the procedure can sometimes cause period like cramps. The procedure involves placing a small tube (about the size of a small drinking straw) through the neck of the womb and then the lining of the uterus (the endometrium) is gently scratched . There will be a small sub-study performed in only in Sheffield where consent will be sought to remove a small amount of tissue from the lining of the womb. This tissue will be stored and later examined in the laboratory which could provide helpful information to tell us why some women may respond better than others to the scratch procedure. Performing the Endometrial Scratch has no clear risks although, in theory, inserting any instrument into the womb could carry a risk of infection. However all women having IVF are routinely screened for important vaginal infections before starting their IVF treatment. The Endometrial Scratch procedure is performed about a week before starting IVF treatment. The study will involve collaboration with 10 units across the UK. Each Unit will have a designated person responsible for the safe running of the study(Principle Investigator) but the overall conduct of the study will lie with the Chief Investigator at the lead site. By the end of the study we hope to be able to tell whether or not endometrial scratch should be offered routinely to women having their first IVF treatment cycle.
Details
Project Status: Ongoing
Anticipated Publish Date: 2021
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England
MeSH Terms
  • Endometrium
  • Female
  • Fertilization in Vitro
  • Pregnancy
  • Pregnancy Rate
  • Embryo Transfer
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
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