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BACKGROUND: Obesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5-10 % of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study will evaluate clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. We hypothesize that the intervention will: 1) improve fertility, efficacy of fertility treatments, and health of mothers and their children; and 2) reduce the cost per live birth, including costs of fertility treatments and pregnancy outcomes. METHODS/DESIGN: Obese infertile women (age: 18-40 years; BMI ≥30 kg/m(2) or ≥27 kg/m(2) with polycystic ovary syndrome) will be randomised to either a lifestyle intervention followed by standard fertility treatments after 6 months if no conception has been achieved (intervention group) or standard fertility treatments only (control group). The intervention and/or follow-up will last for a maximum of 18 months or up to the end of pregnancy. Evaluation visits will be planned every 6 months where different outcome measures will be assessed. The primary outcome will be live-birth rates at 18 months. The secondary outcomes will be sub-divided into four categories: lifestyle and anthropometric, fertility, pregnancy complications, and neonatal outcomes. Outcomes and costs will be also compared to similar women seen in three fertility clinics across Canada. Qualitative data will also be collected from both professionals and obese infertile women. DISCUSSION: This study will generate new knowledge about the implementation, impacts and costs of a lifestyle management program in obese infertile women. This information will be relevant for decision-makers and health care professionals, and should be generalizable to North American fertility clinics. TRIAL REGISTRATION: ClinicalTrials.gov NCT01483612. Registered 25 November 2011.
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OBJECTIVE: To estimate the societal economic burden of illness caused by surgically confirmed endometriosis in Canada in 2009, including direct health care costs, lost productivity, and lost leisure time costs. METHODS: Using a cross-sectional design, direct health care resource use data were obtained from nine family physicians and nine gynaecologists from across Canada, who were experienced in the treatment of women with surgically confirmed endometriosis. Data on alternative treatments and health care providers, as well as work absenteeism, lost leisure time, and caregiver time were obtained from a convenience sample of 27 women with endometriosis treated at two gynaecology clinics in Alberta and Quebec. Unit costs were assigned to resource use items for treatment-seeking patients, and total costs for each resource use item were aggregated to estimate the societal costs of endometriosis in Canada in 2009, across all prevalent cases of surgically confirmed endometriosis. RESULTS: The estimated mean annual societal cost of endometriosis was $5,200 per patient (95% CI $3,700 to $7,100), with lost productivity and lost leisure time costs accounting for 78%. Extrapolating these figures yields an estimated total annual cost to Canadian society of $1.8 billion (95% CI $1.3 billion to $2.4 billion) attributable to surgically confirmed endometriosis in Canada. CONCLUSION: For some women, surgically confirmed endometriosis has a substantial negative impact that can result in suffering to the individual and her family, and lead to substantial productivity losses. Understanding the interplay between direct costs, lost productivity, and quality of life is critical for accurately identifying and evaluating effective treatments for this condition.