Does the removal of small submucous fibroids and endometrial polyps improve the chances of achieving a live birth in women with infertility or recurrent miscarriage?
- Conditions
- Women with infertility or recurrent miscarriage and with a diagnosis of submucous fibroids and/or endometrial polypsPregnancy and ChildbirthFemale infertility, polyp of endometrium, submucous leiomyoma of uterus
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 35
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ive birth rate measured from participant records at 15 months post-randomisation
- Secondary Outcome Measures
Name Time Method