Endometrial Receptivity after Surgical Correction of Uterine Anomalies
Research type
Research Study
Full title
Endometrial Receptivity Before and After Surgical Correction of Uterine Anomalies
IRAS ID
315589
Contact name
Stepehen Quinn
Contact email
Sponsor organisation
Imperial College NHS Foundation Trust
Clinicaltrials.gov Identifier
22SM7740, Sponsor's protocol number
Duration of Study in the UK
2 years, 5 months, 3 days
Research summary
Fibroids are benign smooth muscle tumours of the uterus. A uterine septation is where a band of uterine tissue extends into the uterine cavity from the top of the uterus and is present from birth. Both fibroids and uterine septi are common uterine anomalies associated with infertility and recurrent miscarriage. However, the mechanism by which this occurs is not currently understood. One theory is the presence of either fibroids or a septum reduces the levels of certain genes in the lining of the womb that are important to allow an early pregnancy to implant (so called “endometrial receptivity genes”).
Secondly both of these uterine anomalies can be surgically corrected as part of fertility treatment but it is not currently known if surgically correcting the anomaly (either fibroid or septum) will restore the levels of endometrial genes back to normal levels thus providing a mechanism by which fertility is improved.
We plan to perform a cohort study comparing levels of endometrial receptivity genes before and after surgical correct of both fibroids and uterine septi in patients with infertility or recurrent miscarriage. We will also compare baseline endometrial receptivity gene levels in the patients with uterine anomalies and a control group. Finally we will record fertility outcomes following the surgery such as if patients go on to become pregnant following the surgery and the outcome of that pregnancy.
Participants will have a pipelle biopsy (uterine biopsy that is taken without the need for anaesthetic in an outpatient setting) taken before and after their planned surgery. They will be contacted at 6 monthly intervals for 2 years following their surgery to obtain fertility outcomes. The research will be funded by the CHARM and Tommy's charities and will be recruiting at St Mary's Hospital London.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
22/SW/0110
Date of REC Opinion
8 Sep 2022
REC opinion
Further Information Favourable Opinion