BAMBINI: Bariatric surgery vs Medical care for obesity and polycystic ovarian syndrome related infertility
| ISRCTN | ISRCTN16668711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16668711 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 269196 |
| Protocol serial number | 1.0, IRAS 269196, CPMS 43641 |
| Sponsor | Imperial College London |
| Funders | JP Moulton Charitable Foundation, National Institute for Health Research |
- Submission date
- 22/01/2020
- Registration date
- 11/02/2020
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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, and 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 April 2023
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
Contact information
Public
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
| Phone | +44 (0)2033138070 |
|---|---|
| suhaniya.samarasinghe@nhs.net |
Scientific
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
| Phone | +44 (0)2033138070 |
|---|---|
| a.miras@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre open-label randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Bariatric surgery vs Medical care for obesity and polycystic ovarian syndrome related infertility |
| Study acronym | BAMBINI |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Current primary outcome measure as of 20/02/2023: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 20/02/2023: |
| Completion date | 17/04/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 80 |
| Total final enrolment | 80 |
| Key inclusion criteria | Current inclusion criteria as of 20/02/2023: 1. Pre-menopausal women 18 years and older 2. BMI more than or equal to 35 kg/m² with obesity-related complications 3. Diagnosis of PCOS based on international evidence-based guidelines for the assessment and management of PCOS 2018 Previous 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 |
| Key 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 |
| Date of first enrolment | 20/02/2020 |
| Date of final enrolment | 01/02/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Du Cane Road
London
W12 0HS
United Kingdom
Coventry
CV2 2DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/05/2024 | 04/06/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 4.0 | 05/10/2021 | 29/09/2022 | No | No |
| Statistical Analysis Plan | 23/11/2022 | 05/04/2023 | No | No |
Additional files
- ISRCTN16668711_PROTOCOL_V4.0_05Oct21.pdf
- Protocol file
- ISRCTN16668711 SAP 23.11.22.pdf
- Statistical Analysis Plan
Editorial Notes
04/06/2024: Publication reference added.
29/08/2023: The intention to publish date was changed from 31/08/2023 to 30/11/2023.
16/06/2023: The intention to publish date was changed from 31/05/2023 to 31/08/2023.
05/04/2023: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The intention to publish date was changed from 01/05/2023 to 31/05/2023.
16/03/2023: The overall end date was changed from 20/03/2023 to 17/04/2023.
21/02/2023: The recruitment start date was changed from 01/02/2020 to 20/02/2020.
20/02/2023: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/02/2023 to 20/03/2023.
2. The primary and secondary outcome measures and inclusion criteria were updated.
29/09/2022: The following changes were made to the trial record:
1. Uploaded protocol (not peer reviewed).
2. Total final enrolment added.
3. The overall trial end date was changed from 01/05/2022 to 01/02/2023.
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
