NCT03395067 2018.

Study name	PRO‐FIV
Methods	Study design: parallel‐group randomised controlled trial Setting: single centre/hospital (Spain)
Participants	104 women with infertility and obesity (BMI ≥ 30 kg/m²) before IVF
Interventions	Control: routine care Start of IVF immediately after randomisation Intervention: weight (weight, diet, and physical activity) "Multidisciplinary lifestyle counselling coupled with psycho therapeutical intervention. The aim is a weight loss of at least 10% in a 16‐week period of treatment based on a multidisciplinary approach and support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this period"
Outcomes	Live birth or ongoing pregnancy (live birth of a healthy baby in a non‐complicated pregnancy measured 10 months after start of IVF treatment = primary outcome); any adverse event (perinatal complications of mother and child); miscarriage (3 months after IVF); reported behavioural changes in weight (weight change in kg and BMI 4 months after intervention); birth weight and clinical pregnancy
Starting date	January 2018
Contact information	gcasals@clinic.cat
Notes	Status of study: ongoing; estimated completion date on clinicaltrials.gov is December 2020 Other notes: none