Bariatric surgery for spontaneous ovulation in women living with polycystic ovary syndrome: the BAMBINI multicentre, open-label, randomised controlled trial
Primary result · Number of ovulationsResult — go to the resultIncidence rate ratio 2.5 95% CI 1.5–4.2Authors' conclusion
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.
Study context
- Population
- Women >18 years with polycystic ovary syndrome (PCOS) (2018 international evidence-based guidelines), BMI ≥35 kg/m², and oligomenorrhoea or amenorrhoea; two specialist obesity management centres and social media; median age 31 years, 79% Whiterandomised 1:1
- Participants
- 80 women
- Comparison
- Vertical SG vs behavioural interventions and medical therapy
- Surgicaln = 40
- Medicaln = 40reference
- Primary endpoint
- Number of biochemically confirmed ovulatory events, assessed by weekly serum progesterone
- Follow-up
- 52 weeks
Methodological detailsmulticentre, open-label, Recruited Feb 20, 2020 to Feb 1, 2021, Dropouts: 7 medical, 10 surgical
- Multicentre
- Open-label
- Recruited Feb 20, 2020 to Feb 1, 2021
- Dropouts: 7 medical, 10 surgical
Primary result
Number of ovulations
Incidence rate ratio
2.5
95% CI 1.5–4.2
P < 0.0007
By group
Surgical
6
median · IQR 3.5–10.0
Medical
2
median · IQR 0.0–4.0
Surgicalvs Medical
IRR 2.5 (95% CI 1.5–4.2); P < 0.0007
As reported in the abstract
Safety
Adverse events · per-protocol population
- Adverse events — Treatment-related deaths
- 0
Adverse events
- More complications in the surgical group than the medical group, without long-term sequelae
Original publication
Bariatric surgery for spontaneous ovulation in women living with polycystic ovary syndrome: the BAMBINI multicentre, open-label, randomised controlled trial. Lancet. Published 20 May 2024. doi:10.
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