BAMBINI
Research type
Research Study
Full title
Bariatric surgery vs. Medical care for obesity and polycystic ovarian syndrome related infertility: The BAMBINI randomised-controlled clinical trial
IRAS ID
269196
Contact name
Alexander Miras
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Research Summary
Polycystic ovarian syndrome (PCOS) affects up to 1 in 5 women and is the most common endocrine disorder in women of reproductive potential. Weight-loss treatments have been shown to be effective in improving the number of periods a woman with PCOS can have and eventually get pregnant. Recent data suggest that bariatric surgery, like the vertical sleeve gastrectomy can be effective in achieving this. However, this has not been proven in a high quality randomised controlled clinical trial. This is what is needed to change national and international guidelines and enable PCOS to become an indication for bariatric surgery
The purpose of this study is to evaluate how effective and safe the sleeve gastrectomy is in the treatment of PCOS, i.e. can it make women start having periods. We want to assess this effectiveness by comparing the procedure to lifestyle modification conducted in a centre of excellence.
Summary of results
The BAMBINI RCT has shown that bariatric surgery was superior to medical care in the treatment of women with PCOS, obesity and oligomenorrhoea or amenorrhea. Surgery was associated with a significant increase in ovulation and most reproductive and metabolic parameters.
REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/1540
Date of REC Opinion
10 Dec 2019
REC opinion
Further Information Favourable Opinion