Polyendocrine metabolic ovarian syndrome (PMOS), previously termed polycystic ovary syndrome, is a metabolic–endocrine condition affecting approximately 8–13% of women worldwide. Women with PMOS demonstrate an elevated lifetime risk of cardiovascular disease (CVD). In young women, premature CVD may arise from a cluster of risk factors including atherogenic dyslipidaemia, insulin resistance and increased body weight. High-risk, overweight or obese young women with PMOS commonly present with subclinical markers of cardiovascular disease such as early atherosclerotic changes and cardiac hypertrophy.
Current standard therapy for insulin resistance in PMOS is metformin, which is prescribed to prevent progression to type 2 diabetes. However, existing guidelines and available treatments incompletely address atherogenic lipid abnormalities and the progression of premature subclinical CVD in this population. The trial described here aims to determine whether adding fish oil to standard-of-care metformin improves lipid-related drivers of CVD and reduces progression of vascular and cardiac remodelling and dysfunction in high-risk women with PMOS.
The primary objective is to evaluate the efficacy of fish oil as an adjunct to metformin in reducing key vascular and cardiac markers of early CVD in young women with PMOS. The investigators specifically aim to reduce fasting plasma triglycerides and apoB-lipoproteins, and thereby prevent or limit progression of premature atherosclerosis and adverse cardiac remodelling/dysfunction.
Secondary objectives include assessing changes in blood lipids, apoB-lipoproteins, sex hormones, and glucose–insulin measures, as well as evaluating participant-reported quality of life, adherence and satisfaction with the intervention programme.
This is a randomised, double-blind, placebo-controlled, parallel-group clinical trial designed within a superiority framework. The study will be conducted at the University of Alberta Hospital and affiliated laboratories. The planned conduct period is from November 2025 through July 2028.
Eligible participants are women aged 25–45 years who have a clinical diagnosis of PMOS, a body mass index (BMI) >25 kg/m2 (overweight or obese), and elevated fasting plasma triglyceride or apoB levels. The target sample size is 146 participants.
Recruitment strategies include participant self-identification, outreach via PMOS social media websites, distribution of flyers and referral through clinics located in Edmonton and the Greater Edmonton Area.
Participants will be randomised in a 1:1 ratio to one of two parallel arms for a 12-month intervention period. All participants will receive standard-of-care metformin at a dose of 1500 mg/day.
Both participants and study personnel will be blinded to allocation.
Primary outcome measures:
These primary vascular and cardiac endpoints are intended to capture atherosclerotic burden and myocardial function/remodelling.
Secondary outcomes:
Measurement modalities will include standard biochemical laboratory assays, ultrasound and echocardiography for carotid and cardiac imaging, and MRI where applicable. Questionnaires and qualitative interviews assessing programme satisfaction, adherence and compliance will be administered at the start and end of the trial to inform future PMOS management strategies.
The planned enrolment is 146 participants, allocated equally (1:1) between the experimental and control groups. Randomisation will follow standard procedures to ensure balanced allocation and double-blinding; the protocol uses a parallel-group superiority design. Specific randomisation methods and power calculations were reported in the full protocol but are not detailed in the summary presented here.
Clinical and laboratory data will be collected through routine biochemical testing, imaging (ultrasound/echocardiography and MRI), and validated questionnaires. Interviews will be used to gather qualitative information on adherence and programme satisfaction. Outcome comparisons will focus on primary vascular and cardiac endpoints and key biochemical markers such as fasting triglycerides and apoB.
Statistical analysis plans, including handling of missing data and predefined analysis populations, were included in the trial protocol; the summary notes the superiority framework but does not list specific statistical tests or thresholds here.
The study has received approval from the University of Alberta Human Research Ethics Board (ethics file ID: Pro00141704). Written informed consent will be obtained from all participants prior to enrolment.
Trial outcomes will be disseminated to participants, clinicians managing PMOS, and the scientific community. Planned dissemination activities include infographics posted to relevant PMOS websites, presentations in community forums, presentations at scientific meetings, and publication in peer-reviewed journals.
The trial is scheduled to run from November 2025 to July 2028. The study is registered under trial number NCT06424860. Specific operational milestones and interim status updates were not reported in the source summary.