Researchers led by Imperial College Healthcare NHS Trust, London, UK, are looking to recruit participants to enrol in the Bariatric surgery vs. Medical care for obesity and polycystic ovarian syndrome related infertility (BAMBINI) randomised clinical trial. The study will examine the effects of bariatric surgery vs. lifestyle intervention in premenopausal women over the age of 18 with a diagnosis of polycystic ovarian syndrome (POCS) with a body mass index ≥35kg/m2 and less than eight menstrual periods a year.
The aim of the trial is to change clinical practice by being the first randomised control trial to compare standard medical care to bariatric surgery in women with PCOS, obesity and oligo (irregular) or amenorrhea (absent periods). The trial will be conducted at two research sites – Hammersmith Hospital, London and University Hospital Coventry & Warwickshire, Coventry, UK.
Participants will be randomly allocated to receive either a vertical sleeve gastrectomy or standard medical care following review by a trained psychologist (part of standard medical care). Following the intervention, follow-up will be for 12 months and involve weekly progesterone blood tests and monthly clinical review. Trial participants are asked to use non-hormonal contraception for the duration of the trial. Follow up includes monthly clinical visits with the research team and weekly progesterone blood tests at either Imperial College Healthcare NHS Trust (Charing Cross/Hammersmith/St Marys Hospitals) phlebotomy department or University Hospital Coventry & Warwickshire. Following completion of the trial, women in the standard care group will be given the option for referral for bariatric surgery.
The primary outcome measure is the number of ovulatory cycles within the 12 months follow-up period, defined as a rise in serum progesterone >20 nmol/L, measured using menstrual diaries and weekly blood progesterone levels. Secondary outcome measures include (but are not limited too):
- Reproductive profile, liver function tests, lipid profile, HbA1C using blood test
- Mental health measured using the Hospital anxiety and depression scale
- Multidimensional health profile: health functioning questionnaire score, social functioning questionnaire score, PCOS health-related quality of life score, modified Ferriman-Galwey hirsuitism score, Ludwig visual score, Savin Alopecia Scale score, Cardiff Acne Disability Index
- Number of medications measured using patient records
- Adverse events measured using patient records
- Pregnancy rates measured using patient records
The BAMBINI trial is hoping to recruit 80 participants, recruitment began in February 2020 and is expected to end in February 2021. The trial is funded by the JP Moulton Charitable Foundation the UK’s National Institute for Health Research (NIHR).