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. 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 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). 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. 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. The Jon Moulton Charity Trust.

中文翻译：

---

多囊卵巢综合征女性自发排卵的减肥手术：BAMBINI 多中心、开放标签、随机对照试验


多囊卵巢综合征（PCOS）是无排卵性不孕的最常见原因。肥胖会加剧多囊卵巢综合症的生殖并发症；然而，多囊卵巢综合症女性的肥胖管理仍然是一个巨大的未满足的临床需求。观察性研究表明，减肥手术可以改善排卵周期率和生育前景；然而，尚未在随机试验中将手术对排卵率的功效与行为改变和药物治疗进行比较。本研究的目的是比较减肥手术与医疗护理对患有多囊卵巢综合征、肥胖、月经稀发或闭经的女性排卵率的安全性和有效性。在这项多中心、开放标签、随机对照试验中，80 名年龄超过 18 岁的女性根据 2018 年国际 PCOS 评估和管理循证指南诊断为 PCOS，且 BMI 为 35 kg/m 或更高，他们是从两个专业肥胖管理中心通过社交媒体招募的。参与者按 1:1 的比例随机分配至垂直袖状胃切除术或由不参与临床试验任何其他方面的独立研究人员使用计算机生成的随机序列（SAS 中的 PLAN 程序）进行行为干预和药物治疗。整个队列的平均年龄为 31 岁，79% 的参与者是白人。主要结果是 52 周内生化证实的排卵事件数量，并使用每周血清孕酮测量进行评估。主要终点包括意向治疗人群，安全性分析针对符合方案的人群。本研究已在 ISRCTN 注册中心注册 (ISRCTN16668711)。 参与者招募时间为2020年2月20日至2021年2月1日。每组40名参与者，其中医疗组有7名参与者退出，手术组有10名参与者退出。手术组的中位排卵次数为 6 次（IQR 3·5–10·0），而医疗组的中位排卵次数为 2 次（IQR 3·5–10·0）。与药物组相比，手术组女性的自发排卵次数增加了 2.5 倍（发生率比 2·5 [95% CI 1·5–4·2]，p<0·0007）。手术组的并发症多于药物组，但没有长期后遗症。手术组发生24例（66·7%）不良事件，医疗组发生12例（30·0%）。没有出现与治疗相关的死亡。对于患有多囊卵巢综合症、肥胖、月经稀发或闭经的女性来说，减肥手术比药物治疗更能有效诱导自发排卵。因此，减肥手术可以提高这组女性自然生育的前景。乔恩·莫尔顿慈善信托基金。