NCT03908099 2019.

Study name	Fit‐for‐Fertility
Methods	Study design: parallel‐group randomised controlled trial Setting: multi‐centre/hospital (Canada)
Participants	616 women with infertility (BMI ≥ 30 kg/m² or 27 kg/m² for Asian and Latin American), or BMI ≥ 27 kg/m² for women with PCOS
Interventions	Control: routine care Start of usual fertility care immediately after randomisation. No additional information is provided to control participants on the topics of lifestyle habits, other than recommendations given to them by their gynaecologist and physicians working with participating fertility clinics Intervention: weight (diet, alcohol, physical activity, and smoking) First, Fit for Fertility programme for 6 months followed by usual fertility care for an additional 12 months. Individual sessions with dietician and kinesiologist every 6 to 12 weeks + telephone and email follow‐up via motivational counselling + 8 educational group sessions on addressing healthy lifestyle (healthy eating, sleep, alcohol and tobacco use, behaviour modification and motivation) (45 minutes) in combination with supervised exercise classes (walking, strength training, yoga, circuit training, step workout, and zumba) (45 minutes). Aim is to implement progressive and sustainable lifestyle changes
Outcomes	Live birth or ongoing pregnancy (cumulative incidence of live birth after 24 months (primary outcome) and viable pregnancy of ≥ 10 weeks' gestation). Any adverse event such as gestational diabetes, gestational hypertensive disorders, frequency of complications due to MAR procedures; miscarriage (rate of spontaneous miscarriage). Reported behavioural changes in weight (BMI), diet (nutrient intake (measured with FFQ), physical activity (physical activity behaviour measured with IPAQ, daily energy expenditure measured with fit‐bit and physical fitness measured with 6MWT), alcohol, smoking, and other substance abuse; birth weight; clinical pregnancy (pregnancy rate spontaneous and from MAR), and quality of life (measured with anxiety and depression scales)
Starting date	April 2019
Contact information	farrah.jean‐denis.ciusse‐chus@ssss.gouv.qc.ca
Notes	Status of study: ongoing: recruitment started in 1 hospital. Estimated study completion date on Clinicaltrials.gov is October 2023. Study author replied by email on 7 July 2020: "unfortunately, it would be too preliminary at this point to share any data. The trial is still ongoing and we plan to be able to publish the results in 2024‐2025" Other notes: none