title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01483612. Registered 25 November 2011.
authors.affiliation: 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.
authors.forename: Karine
authors.initials: K
authors.lastname: Duval
authors.affiliation: 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.
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Langlois
authors.affiliation: 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.
authors.forename: Belina
authors.initials: B
authors.lastname: Carranza-Mamane
authors.affiliation: 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.
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Pesant
authors.affiliation: 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.
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Hivert
authors.affiliation: 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.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Poder
authors.affiliation: Procrea Cliniques, Montréal, Québec Canada ; Department of Medicine, Division of Endocrinology, Université de Montréal, Montréal, Québec Canada.
authors.forename: Hélène B
authors.initials: HB
authors.lastname: Lavoie
authors.affiliation: Department of Obstetrics and Gynecology, Université de Sherbrooke, Sherbrooke, Québec Canada.
authors.forename: Youssef
authors.initials: Y
authors.lastname: Ainmelk
authors.affiliation: Nursing School, Université de Sherbrooke, Sherbrooke, Québec Canada.
authors.forename: Denise
authors.initials: D
authors.lastname: St-Cyr Tribble
authors.affiliation: Department of Medicine, Division of Endocrinology, Women's College Hospital, University of Toronto, Toronto, Ontario Canada.
authors.forename: Sheila
authors.initials: S
authors.lastname: Laredo
authors.affiliation: Centre for Fertility and Reproductive Health, Mount Sinai Hospital, University of Toronto, Toronto, Ontario Canada.
authors.forename: Ellen
authors.initials: E
authors.lastname: Greenblatt
authors.affiliation: Department of Obstetrics and Gynaecology, University of Alberta, Edmonton, Ontario Canada.
authors.forename: Margaret
authors.initials: M
authors.lastname: Sagle
authors.affiliation: Department of Obstetrics and Gynecology, Université de Sherbrooke, Sherbrooke, Québec Canada.
authors.forename: Guy
authors.initials: G
authors.lastname: Waddell
authors.affiliation: Department of Obstetrics & Gynecology, Université de Montréal, Montréal, Québec Canada.
authors.forename: Serge
authors.initials: S
authors.lastname: Belisle
authors.affiliation: Quebec Ministry of Health, Québec, Québec Canada.
authors.forename: Daniel
authors.initials: D
authors.lastname: Riverin
authors.affiliation: Research Center of the Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec Canada.
authors.forename: Farrah
authors.initials: F
authors.lastname: Jean-Denis
authors.affiliation: 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.
authors.forename: Matea
authors.initials: M
authors.lastname: Belan
authors.affiliation: 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.
authors.forename: Jean-Patrice
authors.initials: JP
authors.lastname: Baillargeon
keywords: Fertility; Intervention; Lifestyle; Obesity; Polycystic ovary syndrome; Pregnancy; Randomized controlled trial; Weight loss; Women