The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women.

Autor: Duval K; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada ; Division of Endocrinology, Department of medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001-12e Avenue Nord, Sherbrooke, Québec J1H 5N4 Canada., Langlois MF; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada ; Division of Endocrinology, Department of medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001-12e Avenue Nord, Sherbrooke, Québec J1H 5N4 Canada., Carranza-Mamane B; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada ; Department of Obstetrics and Gynecology, Université de Sherbrooke, Sherbrooke, Québec Canada ; Procrea Cliniques, Montréal, Québec Canada., Pesant MH; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada ; Division of Endocrinology, Department of medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001-12e Avenue Nord, Sherbrooke, Québec J1H 5N4 Canada., Hivert MF; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada ; Division of Endocrinology, Department of medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001-12e Avenue Nord, Sherbrooke, Québec J1H 5N4 Canada., Poder TG; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada ; Department of Economics, Faculty of Administration, Université de Sherbrooke, Sherbrooke, Québec Canada ; UETMIS, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada., Lavoie HB; Procrea Cliniques, Montréal, Québec Canada ; Department of Medicine, Division of Endocrinology, Université de Montréal, Montréal, Québec Canada., Ainmelk Y; Department of Obstetrics and Gynecology, Université de Sherbrooke, Sherbrooke, Québec Canada., St-Cyr Tribble D; Nursing School, Université de Sherbrooke, Sherbrooke, Québec Canada., Laredo S; Department of Medicine, Division of Endocrinology, Women's College Hospital, University of Toronto, Toronto, Ontario Canada., Greenblatt E; Centre for Fertility and Reproductive Health, Mount Sinai Hospital, University of Toronto, Toronto, Ontario Canada., Sagle M; Department of Obstetrics and Gynaecology, University of Alberta, Edmonton, Ontario Canada., Waddell G; Department of Obstetrics and Gynecology, Université de Sherbrooke, Sherbrooke, Québec Canada., Belisle S; Department of Obstetrics & Gynecology, Université de Montréal, Montréal, Québec Canada., Riverin D; Quebec Ministry of Health, Québec, Québec Canada., Jean-Denis F; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada., Belan M; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada ; Division of Endocrinology, Department of medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001-12e Avenue Nord, Sherbrooke, Québec J1H 5N4 Canada., Baillargeon JP; Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada ; Division of Endocrinology, Department of medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001-12e Avenue Nord, Sherbrooke, Québec J1H 5N4 Canada.
Jazyk: angličtina
Zdroj: BMC obesity [BMC Obes] 2015 Dec 01; Vol. 2, pp. 47. Date of Electronic Publication: 2015 Dec 01 (Print Publication: 2015).
DOI: 10.1186/s40608-015-0077-x
Abstrakt: 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.
Databáze: MEDLINE
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