Women with infertility or recurrent miscarriage and with a diagnosis of submucous fibroids and/or endometrial polyps Pregnancy and Childbirth Female infertility, polyp of endometrium, submucous leiomyoma of uterus
Conditions
Interventions
Eligible participants will be randomised to one of two groups. One group will have their fibroids of polyps removed by a procedure called hysteroscopic resection. The second group will have their fib
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. History of primary or secondary infertility. Defined as being: 1.1. Of reproductive age who has not conceived after 1 year of unprotected vaginal sexual intercourse, in the absence of any known cause of infertility 1.2. Of reproductive age who is using artificial insemination to conceive (with either partner or donor sperm) who has not conceived after 6 cycles of treatment, in the absence of any known cause of infertility) 1.3. Recurrent miscarriage (defined as the loss of two or more pregnancies before 24 weeks gestation). 2. Diagnosed endometrial polyp or submucosal fibroid =3 cm in size
Exclusion criteria
Exclusion criteria: 1. Submucous fibroids or endometrial polyps >3 cm in size or the presence of additional medical morbidity as a result of the submucous fibroid or endometrial polyps such as anaemia due to heavy periods or significant pain which necessitates surgical intervention 2. Multiple endometrial polyps or submucous fibroids that together amass to >3 cm in total (for example a 2.5 cm fibroid and 1 cm polyp) 3. Asherman’s syndrome 4. Suspected malignancy of endometrial polyp or submucous fibroid 5. Taking part in any other interventional infertility trial 6. Pregnancy or suspected pregnancy 7. Previously randomised into another other HELP Fertility? trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate measured from participant records at 15 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Live birth rate measured from participant records at 24 months post-randomisation 2. Time from randomisation to live birth measured from participant records at 15 and 24 months post-randomisation 3. Time from randomisation to pregnancy measured from participant records at 6, 15, and 24 months post-randomisation 4. Clinical pregnancy, miscarriage, and ectopic pregnancy rates measured from participant records at 6, 15, and 24 months post-randomisation 5. Incidence of premature labour, multiple births and still birth measured from participant records at 15 and 24 months post-randomisation 6. Detail of hysteroscopy received, including the number of hysteroscopic procedures received, duration of time post-surgery abstaining from sexual intercourse, and type of resection performed, collected from participant records within two weeks post-hysteroscopy 7. Patient satisfaction measured using a bespoke questionnaire at 6, 15, and 24 months post-randomisation 7. Details of fertility treatments received, including details of medications received, collected from participant records at 6, 15, and 24 months post-randomisation 8. Details of correct diagnosis/absence of abnormalities at surgery are collected from participant records within two weeks post-hysteroscopy 9. Type of submucous fibroid (type 0, 1, or 2) collected from participant records within two weeks post-hysteroscopy 10. Number of participants in the control arm who undergo resection collected from participant records at 6, 15, and 24 months post-randomisation | — |
Countries
England, United Kingdom
Outcome results
None listed