Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/01/2020
Date assigned
11/02/2020
Last edited
12/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Polycystic ovary syndrome (PCOS) is a common condition that affects how a woman's ovaries work. It is characterised by elevated circulating levels of androgens, problems with ovulation and polycystic ovaries. Difficulty with child bearing is a major cause of emotional distress. Approximately 50% of women with PCOS are overweight or obese and this further impacts on fertility. Weight loss through any means is an effective treatment for improving subfertility in this group of women. Lifestyle modification including healthy eating and increased physical activity is effective in causing short term weight loss but is difficult to maintain long term. Medications also have a positive but modest impact on weight loss. Modern key hole (laparoscopic) surgery is one of the safest operations in the field of surgery and obesity surgery causes significant weight loss. Currently obesity surgery is considered an experimental therapy in women with PCOS for the purpose of having a healthy baby. This study aims to change clinical practice by being the first randomised control trial to compare standard medical care to obesity surgery in women with PCOS, obesity and oligo (irregular) or amenorrhea (absent periods).

Who can participate?
Pre-menopausal women 18 years and older with a BMI ≥ 35 kg/m² with obesity related complications and a diagnosis of PCOS. Participants will need to be within travelling distance of either Imperial College Healthcare NHS trust hospitals (London) or University Hospitals Coventry & Warwickshire NHS Trust (Coventry). This is important due to the need for weekly blood tests and monthly clinical reviews (added 11/03/2020).

What does the study involve?
Participants will be randomly allocated to receive either obesity surgery 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. Following completion of the trial, women in the standard care group will be given the option for referral for obesity surgery.

What are the possible benefits and risks of participating?
Possible benefits: significant weight loss leading to more regular periods. Also regular contact with a specialist.
Risk: obesity surgery sleeve gastrectomy - common risks bleeding, infection, vitamin deficiencies. Will be explained further in detail by the surgical team. Less common risks include a "leak" (leaking of food from the connections made during surgery), a blood clot in the legs or lung, weight regain. Very rare risks include malnutrition and death.
The lifestyle modification programme is safe and risk free

Where is the study run from?
1. Imperial College Healthcare NHS Trust (UK)
2. University Hospitals Coventry and Warwickshire NHS Trust (UK)

When is the study starting and how long is it expected to run for?
February 2020 to November 2021

Who is funding the study?
1. JP Moulton Charitable Foundation, UK
2. National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Dr Suhaniya Samarasinghe (public)
suhaniya.samarasinghe@nhs.net
2. Dr Alexander Miras
a.miras@nhs.net

Trial website

Contact information

Type

Public

Primary contact

Dr Suhaniya Samarasinghe

ORCID ID

Contact details

NIHR Imperial CRF
Imperial Centre for Translational and Experimental Medicine
Imperial College Healthcare NHS Trust
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)2033138070
suhaniya.samarasinghe@nhs.net

Type

Scientific

Additional contact

Dr Alexander Miras

ORCID ID

Contact details

NIHR Imperial CRF
Imperial Centre for Translational and Experimental Medicine
Imperial College Healthcare NHS Trust
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)2033138070
a.miras@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1.0, IRAS 269196, CPMS 43641

Study information

Scientific title

Bariatric surgery vs. Medical care for obesity and polycystic ovarian syndrome related infertility

Acronym

BAMBINI

Study hypothesis

Obesity surgery will be superior to standard medical care in increasing the number of ovulatory cycles in women with PCOS, obesity and oligo or amenorrhoea.

Ethics approval

Approved 10/12/2019, London - Dulwich Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH; +44 (0)207 104 8052; NRESCommittee.London-Dulwich@nhs.net), ref: 19/LO/1540

Study design

Multicentre open-label randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Polycystic ovarian syndrome, obesity

Intervention

Patients will be randomised at a ratio of 1:1, stratified by BMI and trial site (using an online randomisation tool).

Intervention - obesity surgery
Control - standard medical care

Participants will be assessed during a screening visit to check that they meet the inclusion criteria for the trial. They will be provided with further written information at this stage. Successful participants will be randomly allocated to either obesity surgery 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.

Following the completion of the trial, women in the standard care group will be given the option for referral for obesity surgery.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

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

Measured at baseline and then monthly for 12 months (except oral glucose tolerance test):
1. Reproductive profile, liver function tests, lipid profile, HbA1C using blood test
2. Mental health measured using the Hospital anxiety and depression scale
3. 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
4. Arterial blood pressure (mmHg)
5. Oral glucose tolerance test (only baseline and 6 months)
6. Body weight (kg)
7. Waist circumference (cm)
8. Body composition
9. Number of medications measured using patient records
10. Adverse events measured using patient records
11. Pregnancy rates measured using patient records

Overall trial start date

01/11/2019

Overall trial end date

01/05/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Pre-menopausal women 18 years and older
2. BMI more than or equal to 35 kg/m²
3. Obesity-related complications
4. Diagnosis of PCOS based on international evidence-based guidelines for the assessment and management of PCOS 2018
5. Polycystic ovaries on ultrasound

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

1. Type 1 or 2 diabetes mellitus
2. Specific contraindications to obesity surgery
3. Previous obesity surgery
4. Inability to maintain adequate contraception
5. Use of medications affecting reproductive function at screening/3 months prior
6. Other causes of anovulation
7. Current pregnancy/breastfeeding
8. Any medical/psychological/other condition which would potentially either interfere with the study or cause harm to the volunteer
9. Without access at home to a telephone or other factor likely to interfere with the ability to participate reliably in the study

Recruitment start date

01/02/2020

Recruitment end date

01/02/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College Healthcare NHS Trust
Hammersmith Hospital Du Cane Road
London
W12 0HS
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Rd
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Joint Research Compliance Office
Imperial College London and Imperial College Healthcare NHS Trust
Room 215
Level 2
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)207 5949459
jrco@ic.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Charity

Funder name

JP Moulton Charitable Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

All publications and presentations relating to the study will be authorised by the Trial Management Group. The first publication of the trial results will be in the name of the Trial Management Group, if this does not conflict with the journal’s policy. If there are named authors, these will include at least the trial’s Chief Investigator, Statistician and Trial Coordinator. Members of the TMG and the Data Monitoring Committee will be listed and contributors will be cited by name if published in a journal where this does not conflict with the journal’s policy. Authorship of parallel studies initiated outside of the Trial Management Group will be according to the individuals involved in the project. The results are likely to be published within the 12 months following the study in peer-reviewed journals and websites, and presented in medical conferences. Participant confidentiality will be ensured at all times and they will not be identified in any publication as these will be anonymised. A lay summary of the key results from the study will be written and sent and/or presented to them.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/05/2023

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/08/2020: recruitment has resumed. 05/08/2020: The following changes have been made: 1. The recruitment end date has been changed from 01/08/2020 to 01/02/2021. 2. The overall trial end date has been changed from 01/11/2021 to 01/05/2022. 3. The intention to publish date has been changed from 01/11/2022 to 01/05/2023. 09/04/2020: Due to current public health guidance, recruitment for this study has been paused. 11/03/2020: The plain English summary was updated. 06/02/2020: Trial’s existence confirmed by London - Dulwich Research Ethics Committee