Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women
Condition: Female Infertility; Polycystic Ovary Syndrome; Obesity
MeSH terms: Polycystic Ovary Syndrome; Infertility; Infertility, Female
Study type: Interventional

Summary: 
      BACKGROUND: Obesity increases the risk of polycystic ovary syndrome (PCOS), characterized by
      anovulatory cycles, but it is also associated with reduced fertility even in ovulatory women.
      Moreover, obesity increases the costs of assisted human reproduction (AHR) treatments and
      reduces their efficacy. In addition to fertility disorders, obesity increases significantly
      the risks of many complications of pregnancy, delivery and neonatal health. However, a modest
      loss of 5-10% of total body weight can restore ovulation and improve pregnancy rates.

      OBJECTIVES: 1) To design and implement a multidisciplinary program for lifestyle management
      of obese women, or overweight women with PCOS, who seek fertility treatment in a secondary
      AHR center. 2) To evaluate lifestyle benefits of this program and assess its impact on
      fertility, pregnancy and neonatal outcomes, as compared to a randomly assigned control group
      and to similar women seen in tertiary AHR centers. 3) To assess cost per live birth, and
      other measures of cost-effectiveness, of this program compared to the control group and
      tertiary AHR centers. 4) To effectively transfer knowledge obtained through these activities
      to relevant stakeholders in the health care and public health sectors.

      METHODS AND APPROACH: In order to design the program for lifestyle management of obesity in
      infertile women, we will gather a Committee composed of members of our interdisciplinary
      research team and relevant collaborators. Objectives 2 and 3 - In order to achieve these
      objectives, 128 obese women (BMI ≥ 30 kg/m²), or overweight women with PCOS (BMI ≥ 27 kg/m²),
      consulting at the CHUS fertility clinic will be randomized to our lifestyle program, and will
      suspend fertility treatments for six months, or to standard fertility treatments, which are
      directly initiated. The results obtained will also be compared to those of women with the
      same criteria who will consult in 3 tertiary AHR clinics not offering a similar lifestyle
      management program.

      IMPACT: This project is very important as it will generate new knowledge about the
      implementation, impacts and costs of a new lifestyle management program in obese infertile
      women. Our project will obtain valuable data on implementability of such a program; on
      benefits with regard to lifestyle, fertility and maternal and foetal complications during
      pregnancy; as well as on reduction in cost per live birth and other cost-effectiveness ratio.
    


Intervention name(s): Interdisciplinary lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Individual meetings with a dietitian and a kinesiologist at 0, 3, 6 weeks and then every 6 weeks for 18 months or until delivery. A reminder phone call/email will also take place once between each meeting.
The program also includes 12 group sessions discussing subjects about nutrition, psychology and demonstration of physical activity.
Other intervention name(s): Lifestyle program for obese infertile women
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Body Weight; Female; Infertility, Female/therapy; Infertility, Female/physiopathology; Obesity/physiopathology; Polycystic ovary syndrome; Pregnancy; Pregnancy Outcome; Weight Loss