Saint Mary’s staff recruit first participant to national fertility trial
A national fertility study investigating whether removing small growths from the womb improves women’s fertility has launched at Saint Mary’s Hospital.
The HELP Fertility? trial is for women who have been diagnosed with infertility or recurrent miscarriage and have small non-cancerous growths – called fibroids or polyps – in their womb.
Current practice is to remove these growths, however, more scientific evidence is needed to determine whether removal, or leaving them alone, gives women the best chances of having a baby.
The Gynaecology Research Team at Saint Mary’s, which is part of Manchester University NHS Foundation Trust (MFT), recently recruited their first participant to this national study.
Dr Lamiya Mohiyiddeen, Consultant Gynaecologist and Subspecialist in Reproductive Medicine and Surgery, at Saint Mary’s Hospital, is the co-applicant for this study. She is leading the study locally as Principal Investigator (PI) along with Dr Mariam Lokman as the Associate PI. Dr Lokman is a Consultant in Reproductive Medicine at Saint Mary’s Hospital. This study is the first to introduce the new National Institute for Health and Care Research (NIHR) Associate PI scheme at Saint Mary’s Hospital.
Dr Mohiyiddeen said: “Fertility research is essential in order to improve reproductive health and treatment. The fertility journey is a significant and often emotional time in the life of our patients.
“The HELP Fertility? Trial addresses the question of whether hysteroscopic removal of small submucosal fibroids and endometrial polyps is evidenced by improved fertility outcomes. Many women are currently waiting for these procedures before undergoing fertility treatment, and we hope this research will help address whether this improves their chances of conceiving.
The trial has been designed by researchers at Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield, with funding from the NIHR Health Technology Assessment (NIHR HTA) Programme.
Nationally the study is led by Chief Investigator Dr Mostafa Metwally, Sheffield Teaching Hospitals NHS Foundation Trust.
During the study, women will be randomised to either the control group, where growths are left alone, or the intervention group, and undergo surgery (called a hysteroscopic resection) to remove them. Researchers will then monitor whether women become pregnant in the 24 months after signing up, alongside information from their medical notes.
The lead trial team in Sheffield has also produced a video explaining the trial.