Semen samples are commonly processed by a density gradient centrifugation method to isolate the most motile spermatozoa for fertilisation during in vitro fertilisation (IVF). Centrifugation can cause considerable damage to spermatozoa by the reactive oxygen species produced during the process, which has a negative effect on the IVF success. A microfluidic chip is an alternative sperm preparation technique using a miniaturised device containing channels and chambers in the microscale range for nanoparticle preparation. This technology enables the selection of mobile spermatozoa from semen samples without the need of centrifugation, leading to reduced DNA fragmentation. This study aims to compare the cumulative live birth rate of IVF following sperm preparation by a microfluidic chip method versus a density gradient centrifugation method.

This is a randomised double-blind study. Infertile patients attending the Centre of Assisted Reproduction and Embryology, Queen Mary Hospital and Kwong Wah Hospital for IVF will be recruited. With an anticipated 10% increase in live birth rate following the use of a microfluidic chip method, the calculated sample size is 516 women in each group to give a power of 0.8 and type 1 error of 0.05. Assuming a 10% drop-out rate, the total sample size is set to be 1136 or 568 women in each group. They will be randomly assigned on the day of oocyte retrieval by a laboratory staff into one of the following two groups: (1) the microfluidic chip group and (2) the density gradient group for sperm preparation and subsequent use in fertilisation. Other IVF procedures will be the same as our standard practice. Both patients and clinicians were blinded from the group allocation. The primary outcome is the cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation. The cumulative live birth rates between the two groups will be analysed by ² test.

Ethical approval was granted from the Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster (Approval Number: UW 23–293) and the Institutional Review Board of Kwong Wah Hospital (Approval Number: KC/KE-23-0108/FR-4). A written informed consent will be obtained from each woman before any study procedure according to good clinical practice. The results of this randomised trial will be disseminated in a peer-reviewed journal.

NCT06005311.

Common mental disorders (CMDs) are endemic globally. The availability of evidence-based mental health interventions has grown rapidly, with many services focused on psychotherapy. Most psychotherapies require multiple sessions, resulting in lengthy waiting times due to limited provider availability. These delays can lead to higher morbidity, poorer adherence and less favourable outcomes.

Recent research indicates that single-session therapy (SST) can be as effective as multi-session approaches and offers cost savings. This pragmatic, prospective mixed-methods pilot cohort study assesses the uptake, feasibility, acceptability, appropriateness and preliminary clinical effectiveness of SST in individuals receiving the Friendship Bench intervention. The Friendship Bench is a task-shifting mental health intervention for individuals with low to moderate symptoms of CMDs.

We will conduct a pragmatic, prospective, mixed-methods pilot interventional cohort study involving 350 first-time clients of the Friendship Bench intervention in Harare and surrounding periurban areas. We will primarily explore the intervention’s feasibility, uptake, appropriateness and acceptability including the feasibility of a larger follow-up clinical trial. Secondary outcomes include changes in CMDs severity, depression and anxiety symptoms, social connectedness, functional status, hope, resilience, health-related quality of life and therapeutic alliance. Participants will be followed for 6 weeks, with data collected at baseline and at 2, 4 and 6 weeks postintervention time points. A qualitative component will explore participants’ perspectives and experiences with SST. Quantitative data will be analysed using descriptive statistics, bivariate analysis, Cox proportional hazards models and generalised mixed models with maximum likelihood estimation. Qualitative data will be analysed thematically.

Ethical approval was granted by the Medical Research Council of Zimbabwe. Findings from this study will contribute to the evidence base for SST in the management of CMDs and may inform mental health service delivery in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations, social media platforms and policy briefs.

PACTR202605687485459

An affordable heart-healthy dietary approach is essential for the management of familial hypercholesterolaemia (FH); however, the optimal dietary pattern and the role of adjunctive nutrient supplementation remain uncertain. This study aims to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br), adapted from the Portfolio Diet, with or without phytosterol and/or krill oil supplementation in individuals with probable or definite FH according to the Dutch Lipid Clinic Network (Dutch MEDPED) criteria.

The DICA-FH study is a national, multicentre, randomised, factorial, parallel-group, superiority, placebo-controlled clinical trial with a 1:1:1:1 allocation ratio. Participants aged ≥16 years receiving age-appropriate lipid-lowering therapy will be randomised into four groups: (1) adapted cardioprotective diet (DICA-FH) plus phytosterol placebo and krill oil placebo; (2) DICA-FH plus phytosterol 2 g/day and krill oil placebo; (3) DICA-FH plus phytosterol placebo and krill oil 2 g/day or (4) DICA-FH plus phytosterol 2 g/day and krill oil 2 g/day. All participants will undergo whole-genome sequencing and receive appropriate genetic counselling. Primary outcomes will be means of low-density lipoprotein cholesterol and lipoprotein(a) levels after 120 days. Secondary outcomes will include additional lipid biomarkers, adherence to protocol and adverse events. The planned sample size is 300 participants. Follow-up is expected to conclude in July 2026.

This study was registered under CAAE 65549622.2.1001.0060 and received ethical approval from the Hcor Research Ethics Committee (approval number 5.805.072) and the Brazilian National Research Ethics Commission (CONEP; approval number 6.864.951). Written informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through peer-reviewed publications, scientific conferences and channels aimed at the general public.

NCT06331195.

This study aimed to evaluate the impact of a social prescribing intervention (the Central Locality Integrated Care Service (CLICS)) on unplanned hospital usage in the city of Bradford.

A quasi-experimental study applying a dynamic staggered difference-in-differences (DID) analysis on a propensity matched cohort between 2019 and 2023, using data from the Connected Bradford dataset, a pseudonymised linked health dataset on the whole Bradford population.

CLICS was delivered within general practices in deprived and ethnically diverse inner-city areas of Bradford, Yorkshire, UK.

In total, 1304 CLICS patients were matched to 5216 control patients on key characteristics including ethnicity, deprivation, age, gender and health conditions.

A proactive social prescribing intervention that integrates clinical and non-clinical services, including an individualised approach to tailor support based on the patient’s needs, both within primary care services and by linking them to appropriate community-based assets/services.

The primary outcome was the rate of unplanned hospital admissions and the secondary outcome was unplanned accident and emergency (A&E) attendances.

CLICS patients were 2.1% (95% CI –3.8% to –0.4%, p=0.013) less likely to have an unplanned hospital admission and 2.4% (95% CI –4.6% to –0.2%, p=0.03) less likely to have an unplanned A&E attendance compared with the matched control. The DID analysis demonstrated a gradual increase in the association over time. Subanalyses revealed heterogeneity by ethnicity, the reduction in unplanned hospital admissions was observed only in patients of the Pakistani group, whereas the reduction in A&E attendances was statistically significant only in the white British group.

The CLICS intervention was associated with a reduction in unplanned hospital usage. Social prescribing may be a valuable component of strategies to reduce health inequalities in unplanned hospital usage.