Bariatric surgery for spontaneous ovulation in women living with polycystic ovary syndrome: the BAMBINI multicentre, open-label, randomised controlled trial.

Autor:	Samarasinghe SNS; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK; Department of Diabetes & Endocrinology, Imperial College Healthcare NHS Trust, London, UK., Leca B; Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK; Warwick Medical School, University of Warwick, Warwick, UK., Alabdulkader S; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK; Department of Health Sciences, College of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia. Electronic address: saalabdulkader@pnu.edu.sa., Dimitriadis GK; Obesity, Type 2 Diabetes and Immunometabolism Research Group, Faculty of Cardiovascular and Metabolic Medicine & Sciences, King's College London, London, UK., Davasgaium A; Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK; Warwick Medical School, University of Warwick, Warwick, UK., Thadani P; Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK; Warwick Medical School, University of Warwick, Warwick, UK., Parry K; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK., Luli M; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK., O'Donnell K; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK., Johnson B; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK., Abbara A; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK., Seyfried F; Department of Surgery, University of Würzburg, Würzburg, Germany., Morman R; Verity-The UK PCOS Charity, London, UK., Ahmed AR; Department of Surgery, Imperial College London, London, UK., Hakky S; Brunel University, Division of Life Sciences, London, UK., Tsironis C; Department of Surgery, Imperial College London, London, UK., Purkayastha S; Imperial Weight Centre, Imperial College Healthcare NHS Trust, London, UK; Brunel University, Division of Life Sciences, London, UK., le Roux CW; Diabetes Control And Complications Centre, University College Dublin, Dublin, Ireland., Franks S; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK., Menon V; Department of Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK; Warwick Medical School, University of Warwick, Warwick, UK., Randeva H; Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK; Warwick Medical School, University of Warwick, Warwick, UK., Miras AD; Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK; School of Medicine, Ulster University, Derry, UK.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2024 Jun 08; Vol. 403 (10443), pp. 2489-2503. Date of Electronic Publication: 2024 May 20.
DOI:	10.1016/S0140-6736(24)00538-5
Abstrakt:	Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility. Obesity exacerbates the reproductive complications of PCOS; however, the management of obesity in women with PCOS remains a large unmet clinical need. Observational studies have indicated that bariatric surgery could improve the rates of ovulatory cycles and prospects of fertility; however, the efficacy of surgery on ovulation rates has not yet been compared with behavioural modifications and medical therapy in a randomised trial. The aim of this study was to compare the safety and efficacy of bariatric surgery versus medical care on ovulation rates in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. Methods: In this multicentre, open-label, randomised controlled trial, 80 women older than 18 years, with a diagnosis of PCOS based on the 2018 international evidence-based guidelines for assessing and managing PCOS, and a BMI of 35 kg/m 2 or higher, were recruited from two specialist obesity management centres and via social media. Participants were randomly assigned at a 1:1 ratio to either vertical sleeve gastrectomy or behavioural interventions and medical therapy using a computer-generated random sequence (PLAN procedure in SAS) by an independent researcher not involved with any other aspect of the clinical trial. The median age of the entire cohort was 31 years and 79% of participants were White. The primary outcome was the number of biochemically confirmed ovulatory events over 52 weeks, and was assessed using weekly serum progesterone measurements. The primary endpoint included the intention-to-treat population and safety analyses were per-protocol population. This study is registered with the ISRCTN registry (ISRCTN16668711). Findings: Participants were recruited from Feb 20, 2020 to Feb 1, 2021. 40 participants were assigned to each group and there were seven dropouts in the medical group and ten dropouts in the surgical group. The median number of ovulations was 6 (IQR 3·5-10·0) in the surgical group and 2 (0·0-4·0) in the medical group. Women in the surgical group had 2.5 times more spontaneous ovulations compared with the medical group (incidence rate ratio 2·5 [95% CI 1·5-4·2], p<0·0007). There were more complications in the surgical group than the medical group, although without long-term sequelae. There were 24 (66·7%) adverse events in the surgical group and 12 (30·0%) in the medical group. There were no treatment-related deaths. Interpretation: Bariatric surgery was more effective than medical care for the induction of spontaneous ovulation in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. Bariatric surgery could, therefore, enhance the prospects of spontaneous fertility in this group of women. Funding: The Jon Moulton Charity Trust. Competing Interests: Declaration of interests ADM has received research funding from the Medical Research Council (MRC), National Institute for Health and Care Research (NIHR), Jon Moulton Charitable Foundation, Anabio, Fractyl, Boehringer Ingelheim, Gila, Randox, and Novo Nordisk. ADM has received honoraria for lectures and presentations from Novo Nordisk, AstraZeneca, Currax Pharmaceuticals, Boehringer Ingelheim, Screen Health, GI Dynamics, Algorithm, Eli Lilly, Ethicon, and Medtronic. ADM and CWlR are shareholders in the Beyond BMI clinic, which provides clinical obesity care. SA was supported by Princess Nourah bint Abdulrahman University Researchers Supporting Project (PNURSP2024R530), Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia. CWlR reported grants from the Irish Research Council, Science Foundation Ireland, Anabio, and the Health Research Board. CWlR has received honoraria for lectures and presentations from Novo Nordisk, Herbalife, Eli Lilly, Johnson & Johnson, Rhythm Pharmaceuticals, Currax Pharmaceuticals, and Boehringer Ingelheim. CWlR serves on advisory boards of Novo Nordisk, Herbalife, GI Dynamics, Eli Lilly, Johnson & Johnson, Altimmune, Irish Life Health, and Boehringer Ingelheim. CWlR plays a leadership role in the Irish Society for Nutrition and Metabolism. CWlR was the Chief Medical Officer and Director of the Medical Device Division of Keyron in 2021—both of these were unremunerated positions. CWlR was a previous investor in Keyron, which developed endoscopically implantable medical devices that mimic the surgical procedures of sleeve gastrectomy and gastric bypass. CWlR does not have any contracts with other companies to put their products into clinical practice. CWlR continues to provide scientific advice to Keyron for no remuneration. AA was supported by the NIHR Clinician Scientist Award and MRC project grant. AA has received consulting fees from Myovant Sciences and honoraria for a lecture from Merck. AA serves on the public engagement committee of the Society for Endocrinology. FS has received a grant from the Deutsche Forschungsgemeinschaft (2027/5–1). BL, AD, and PT received a grant from the Jon Moulton Charitable Foundation. GKD has received research grants from the NIHR, Novo Nordisk, and Diabetes Digital Media, as well as payment or honoraria for lectures and presentations from Novo Nordisk, Rhythm Pharmaceuticals, Eli Lilly, Ethicon, and Medtronic. GKD is a co-founder and shareholder in the Heracles Project clinic, which provides clinical care for men's health. GKD plays a leadership role in The Association for the Study of Obesity and is a member of the Society for Endocrinology–British Endocrine Society. RM has received a grant from the Waterloo Foundation, as well as payment and support from Roche Diagnostics and the Androgen Excess and Polycystic Ovary Syndrome Society. HR has received a grant from the Jon Moulton Charitable Foundation, as well as payment or honoraria from Novo Nordisk and support from Ipsen. All other authors declare no competing interests. (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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