Fit-for-Fertility Multicenter Randomized Controlled Trial

1. BACKGROUND

Infertility affects approximately 10-15% of couples and costs associated with medically assisted reproduction (MAR) are growing, such that equitable access to high quality reproductive care is a challenge for the Canadian health care system. This is especially true for women with obesity. A modifiable risk factor for infertility is obesity (body mass index (BMI) \>= 30 kg/m2), which accounts for as many as 19% of Canadian women of reproductive age. Moreover, obesity increases the costs of fertility treatments, reduces their effectiveness and predisposes to several pregnancy and neonatal complications. As important, maternal pre-pregnancy BMI and excessive gestational weight gain were consistently associated with early development of obesity and diabetes in the offspring. Childhood obesity is closely linked to adult obesity, which perpetuates the intergenerational cycle of obesity. Accordingly, we strongly believe that targeting women with obesity prior to conception may be essential to reduce the burden of infertility and MAR costs in Canada, as well as obesity and cardiometabolic diseases.

To prevent these adverse effects, many organizations have recommended that obese women should be assisted to adopt a healthy lifestyle prior to conception and maintain it during pregnancy. In a recent survey, all women who were obese or overweight and considering pregnancy were interested in adopting a healthy lifestyle pre-conception and 91% reported their willingness to participate in a lifestyle program. However, most Canadian women with obesity do not have access to such targeted lifestyle programs integrated with their fertility care. Our solution is therefore to give these women access to the Fit-for-Fertility Program, an interdisciplinary lifestyle intervention, integrated into the fertility clinic care pathway. This program supports participants in their adoption of sustainable healthy behaviours, prior conception and during pregnancy.

To fill these gaps, in 2010 Dr. Baillargeon set up the Canadian network on reproductive and maternal health of women with obesity and infertility. Through this network, our team has conducted a CIHR-funded RCT evaluating the impact of the Fit-for-Fertility Program, which was implemented at the fertility clinic of the Centre hospitalier universitaire de Sherbrooke (CHUS), on 130 obese women randomized to 1) Control group: standard fertility treatments right away; or 2) Intervention group: follow the Fit-for-Fertility program alone for 6 months, then in combination with fertility treatments if not pregnant. The analysis of the 108 women who completed at least 6 months in the study (83%) shows that after a maximum follow-up of 18 months and in comparison with the standard fertility treatments (n = 57), the Fit-for-Fertility program (n = 51) significantly increased the rates of total pregnancy (61% vs. 39%, p = 0.02) and spontaneous pregnancy (31% vs. 12%, p = 0.01), as well as a tendency to increase live birth (51% vs. 37%, p = 0.14). Such results from the pilot study are highly clinically significant. The total cost of this intervention was only $870 per participant, as compared to standard fertility care costs averaging $4,400 per woman with obesity in the above-mentioned trial. As such, these preliminary results thus suggest that our low-cost lifestyle intervention for women who are obese and infertile may significantly improve their fertility and reduce the need for expensive MAR. These promising findings provide strong justification for further validation in diverse Canadian populations using a multicenter trial.