A blended preconception lifestyle programme for couples undergoing IVF: lessons learned from a multicentre randomized controlled trial.
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ABSTRACT:
SUBMITTER: Boedt T
PROVIDER: S-EPMC10918763 | biostudies-literature | 2023
REPOSITORIES: biostudies-literature
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A blended preconception lifestyle programme for couples undergoing IVF: lessons learned from a multicentre randomized controlled trial.
Boedt Tessy T Dancet Eline E De Neubourg Diane D Vereeck Sofie S Jan Seghers S Van der Gucht Katleen K Van Calster Ben B Spiessens Carl C Lie Fong Sharon S Matthys Christophe C
Human reproduction open 20230929 4
<h4>Study question</h4>What is the effect of a blended preconception lifestyle programme on reproductive and lifestyle outcomes of couples going through their first 12 months of IVF as compared to an attention control condition?<h4>Summary answer</h4>This randomized controlled trial (RCT) was stopped prematurely because of the coronavirus disease 2019 (Covid-19) pandemic but the available data did not suggest that a blended preconception lifestyle programme could meaningfully affect time to ongo ...[more]
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Project description:IntroductionInfertility and in vitro fertilisation (IVF; with or without intracytoplasmic sperm injection) result in considerable emotional and financial burden. Increasing evidence suggests that lifestyle factors, including diet, physical activity and personal well-being, are associated with IVF-success rates. Currently, IVF is not routinely combined with a lifestyle programme. The preconception lifestyle (PreLiFe) randomised controlled trial (RCT) assesses the effects of a new mobile PreLiFe programme in couples undergoing IVF.Methods and analysisA multicentre RCT including 460 heterosexual couples starting IVF in Belgian fertility clinics. IVF couples are randomised between an attention control group or the PreLiFe programme for a period of 12 months or until an ongoing pregnancy is confirmed by ultrasound. The attention control programme includes a mobile application with treatment information (ie, appointments and medication instructions) in addition to standard care. The PreLiFe programme includes a mobile application with the same treatment information in combination with a lifestyle programme. This new lifestyle programme includes tailored advice and skills training on diet, physical activity and mindfulness in combination with text messages and telephone interaction with a healthcare professional trained in motivational interviewing. The primary outcome of this RCT is the cumulative ongoing pregnancy rate within 12 months after randomisation. Secondary outcomes include changes in diet, physical activity, emotional distress, body mass index, waist circumference, quality of life and other reproductive outcomes including IVF discontinuation, clinical pregnancy rate and time to pregnancy. Additionally, partner support and the feasibility (use and acceptability) of the PreLiFe programme will be evaluated in the intervention group. Analysis will be according to intention to treat.Ethics and disseminationThis study has been approved by the Medical Ethical Committee of the Leuven University Hospital (Belgium) and the other recruiting clinics. The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications.Trial registration numberNCT03790449; Pre-results.
| S-EPMC6678004 | biostudies-literature
Project description:ObjectiveTo study implications of psychological distress on in vitro fertilization (IVF) outcome of an infertile couple.MethodsProspective study in an academic infertility practice setting. Couples undergoing embryo transfer (ET) following IVF were offered participation. Female patient (n = 89) and partner (n = 77) completed questionnaires reflecting dysphoria (POMS) and pessimism (LOT) after undergoing ET. Relationship between dysphoria and pessimism and implications of individual and couple's psychological distress on IVF cycle parameters and outcomes were assessed using multivariable analyses.ResultsStatistically significant correlations between dysphoria and pessimism were observed within the individual and between partners, (p < 0.01). Higher couple pessimism correlated with longer duration of controlled ovarian hyperstimulation (COH, p = 0.02); higher partner psychological distress related to lower fertilization rate (FR, p = 0.03). On adjusted analyses, partner's depression score was an independent predictor of reduced likelihood of clinical pregnancy (p = 0.03).ConclusionsOur data validate the concept of a "stressed couple". Adverse implications of a couple's psychological distress for gamete biology (longer duration of COH and lower FR with increasing distress) are suggested. Partner's depressive scores negatively correlated with IVF success. These findings suggest the importance of including partner's evaluation in studies that focus on effects of psychological stress on IVF outcome; future studies should examine whether interventions aimed at reducing psychological stress for the infertile couple may improve IVF cycle success.
| S-EPMC3879930 | biostudies-literature
Project description: Not available
| S-EPMC11272172 | biostudies-literature
Project description:BackgroundType 2 diabetes mellitus is preventable through lifestyle intervention. Diabetes prevention programmes (DPPs) aim to deliver prevention-based behaviour change interventions to reduce incidence. Such programmes vary from usual primary care in terms of where, how, and by whom they are delivered. Implementation is therefore likely to face new commissioning, incentive and delivery challenges. We report on the implementation of a national DPP in NHS England, and identify lessons learned in addressing the implementation challenges.MethodsIn 2017/18, we conducted 20 semi-structured telephone interviews covering 16 sampled case sites with the designated lead(s) responsible for local implementation of the programme. Interviews explored the process of implementation, including organisation of the programme, expectations and attitudes to the programme, funding, target populations and referral and clinical pathways. We drew on constant comparative methods to analyse the data and generate over-arching themes. We complemented our qualitative data with a survey focused on variation in the financial incentives used across sites to ensure usual primary care services recruited patients to new providers.ResultsWe identified five over-arching areas of learning for implementing this large-scale programme: 1) managing new providers; 2) promoting awareness of services; 3) recruiting patients; 4) incentive payments; and 5) mechanisms for sharing learning. In general, tensions appeared to be caused by a lack of clear roles/responsibilities between hierarchical actors, and lack of communication. Both local sites and the national NHS coordination team gained experience through learning by doing. Initial tensions with roles and expectations have been worked out during implementation.ConclusionsImplementing a national disease prevention programme is a major task, and one that will be increasingly faced by health systems globally as they aim to adjust to demand pressures. We provide practical learning opportunities for the wider uptake and sustainability of prevention programmes. Future implementers might wish to define clear responsibilities for each actor prior to implementation, ensure early engagement with new providers, offer mechanisms/forums for sharing learning, generate evidence and provide advice on incentive payments, and prioritise public and professional awareness of the programme.
| S-EPMC6929377 | biostudies-literature
Project description:Continual course correction during implementation of nutrition programmes is critical to address factors that might limit coverage and potential for impact. Programme improvement requires rigorous scientific inquiry to identify and address implementation pathways and the factors that affect them. Under the auspices of "The Micronutrient Powders Consultation: Lessons Learned for Operational Guidance," 3 working groups were formed to summarize experiences and lessons across countries regarding micronutrient powder (MNP) interventions for young children. This paper focuses on how MNP interventions undertook key elements of programme improvement, specifically, the use of programme theory, monitoring, process evaluation, and supportive supervision. Methods included a review of published and grey literature, interviews with key informants, and deliberations throughout the consultation process. We found that although much has been written and published about the use of monitoring and process evaluation to inform MNP interventions at small scale, there has been little formal documentation of lessons for the transition from pilot to scaled implementation. Supervision processes and experiences are not documented, and to our knowledge, there is no evidence of whether they have been effective to improve implementation. Improving the efficiency and effectiveness of interventions requires identification of critical indicators for detecting implementation challenges and drivers of impact, integration with existing programmes and systems, strengthened technical capacity, and financing for implementation of effective monitoring systems. Our understanding of programme improvement for MNP interventions is still incomplete, especially outside of the pilot stage, and we propose a set of implementation research questions that require further investigation.
| S-EPMC5656835 | biostudies-literature
Project description:To answer the question of whether preconception phthalate and phthalate replacements associated with sperm differentially methylated regions (DMRs) among men undergoing in-vitro fertilization, genome-wide DNA-methylation profiles of 48 human sperm samples were generated by bisulfite-based Illumina 450K BeadChip arrays. The sperm DNA methylation is then correlated with urinary phthalate metabolite concentrations.
2017-10-01 | GSE102970 | GEO
Project description:BackgroundClinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early in-bed cycling in the intensive care unit (ICU). In-bed cycling is a novel intervention, not typically available in ICUs. Implementation of this intervention requires personnel with specialized clinical expertise caring for critically ill patients and use of the in-bed cycle. Our objective was to describe the implementation and conduct of our pilot RCT using a project management approach.MethodsWe retrospectively reviewed activities, timelines, and personnel involved in the trial. We organized activities into four project management phases: initiation, planning, execution, and monitoring and controlling. Data sources included Methods Centre documents used for trial coordination and conduct, and the trial data set. We report descriptive statistics as counts and proportions and also medians and quartiles, and we summarize the lessons learned.ResultsSeven ICUs in Canada participated in the trial. Time from research ethics board and contracts submission to first enrolment was a median (first quartile, third quartile) of 185 (146, 209) and 162 (114, 181) days, respectively. We trained 128 personnel on the CYCLE pilot RCT protocol, and 80 (63%) completed trial-related activities. Four sites required additional training after start-up due to staff turnover and leaves of absence. Over 15 months, we screened 864 patients: 256 were eligible and 66 were enrolled. Despite an 85% consent rate, 74% (190/256) of eligible patients were not randomized, largely (80% [152/190]) due to physiotherapist availability. Thirteen percent of recruitment weeks were lost due to physiotherapist staffing shortages. We highlight five key lessons learned: (1) prepare and anticipate site needs; (2) communicate regularly; (3) proactively analyse and act on process measure data; (4) develop contingency plans; (5) express appreciation to participating sites.ConclusionsOur analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation.Trial registrationClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.
| S-EPMC6712681 | biostudies-literature
Project description:IntroductionIn the context of a GP-based care programme, we implemented an admission, discharge and follow-up programme.DescriptionThe VESPEERA programme consists of three sets of components: pre-admission interventions, in-hospital interventions and post-discharge interventions. It was aimed at all patients with a hospital stay participating in the GP-based care programme and was implemented in 7 hospitals and 72 general practices in southwest Germany using a range of strategies. Its' effectiveness was evaluated using readmissions within 90 days after discharge as primary outcome. Questionnaires with staff were used to explore the implementation process.DiscussionA statistically significant effect was not found, but the effect size was similar to other interventions. Intervention fidelity was low and contextual factors affecting the implementation, amongst others, were available resources, external requirements such as legal regulations and networking between care providers. Lessons learned were derived that can aid to inform future political or scientific initiatives.ConclusionStructured information transfer at hospital admission and discharge makes sense but the added value in the context of a GP-based programme seems modest. Primary care teams should be involved in pre- and post-hospital care.
| S-EPMC9881439 | biostudies-literature
Project description:Study questionAre preconception phthalate and phthalate replacements associated with sperm differentially methylated regions (DMRs) among men undergoing IVF?Summary answerTen phthalate metabolites were associated with 131 sperm DMRs that were enriched in genes related to growth and development, cell movement and cytoskeleton structure.What is known alreadySeveral phthalate compounds and their metabolites are known endocrine disrupting compounds and are pervasive environmental contaminants. Rodent studies report that prenatal phthalate exposures induce sperm DMRs, but the influence of preconception phthalate exposure on sperm DNA methylation in humans is unknown.Study design, size, durationAn exploratory cross-sectional study with 48 male participants from the Sperm Environmental Epigenetics and Development Study (SEEDS).Participants/materials, setting, methodsThe first 48 couples provided a spot urine sample on the same day as semen sample procurement. Sperm DNA methylation was assessed with the HumanMethylation 450 K array. Seventeen urinary phthalate and 1,2-Cyclohexane dicarboxylic acid diisononyl ester (DINCH) metabolite concentrations were measured from spot urine samples. The A-clust algorithm was employed to identify co-regulated regions. DMRs associated with urinary metabolite concentrations were identified via linear models, corrected for false discovery rate (FDR).Main results and role of chanceAdjusting for age, BMI, and current smoking, 131 DMRs were associated with at least one urinary metabolite. Most sperm DMRs were associated with anti-androgenic metabolites, including mono(2-ethylhexyl) phthalate (MEHP, n = 83), mono(2-ethyl-5-oxohexyl) phthalate (MEOHP, n = 16), mono-n-butyl phthalate (MBP, n = 22) and cyclohexane-1,2-dicarboxylic acid-monocarboxy isooctyl (MCOCH, n = 7). The DMRs were enriched in lincRNAs as well as in regions near coding regions. Functional analyses of DMRs revealed enrichment of genes related to growth and development as well as cellular function and maintenance. Finally, 13% of sperm DMRs were inversely associated with high quality blastocyst-stage embryos after IVF.Limitations, reasons for cautionOur modest sample size only included 48 males and additional larger studies are necessary to confirm our observed results. Non-differential misclassification of exposure is also a concern given the single spot urine collection.Wider implications of the findingsTo our knowledge, this is the first study to report that preconception urinary phthalate metabolite concentrations are associated with sperm DNA methylation in humans. These results suggest that paternal adult environmental conditions may influence epigenetic reprogramming during spermatogenesis, and in turn, influence early-life development.Study funding/competing interest(s)This work was supported by grant K22-ES023085 from the National Institute of Environmental Health Sciences. The authors declare no competing interests.
| S-EPMC5850785 | biostudies-literature
Project description:BackgroundExpanded carrier screening can provide risk information for numerous conditions. Understanding how individuals undergoing preconception expanded carrier screening value this information is important. The NextGen study evaluated the use of genome sequencing for expanded carrier screening and reporting secondary findings, and we measured participants' willingness to pay for this approach to understand how it is valued by women and couples planning a pregnancy.MethodsWe assessed 277 participants' willingness to pay for genome sequencing reporting carrier results for 728 gene/condition pairs and results for 121 secondary findings. We explored the association between attitudes and demographic factors and willingness to pay for expanded carrier screening using genome sequencing and conducted interviews with 58 of these participants to probe the reasoning behind their preferences.ResultsMost participants were willing to pay for expanded carrier screening using genome sequencing. Willingness to pay was associated with income level and religiosity, but not risk status for a condition in the carrier panel. Participants willing to pay nothing or a small amount cited issues around financial resources, whereas those willing to pay higher amounts were motivated by "peace of mind" from carrier results.ConclusionWomen and couples planning a pregnancy value genome sequencing. The potentially high out-of-pocket cost of this service could result in healthcare disparities, since maximum amounts that participants were willing to pay were higher than a typical copay and related to income.
| S-EPMC6051630 | biostudies-literature