Dupont 2020.
Study name | PEPCI |
Methods |
Study design: parallel‐group randomised controlled trial (on the fly) Setting: multi‐centre/hospital (France) |
Participants | 750 heterosexual couples with infertility or couples attending a visit at an ART reproductive centre |
Interventions |
Control: routine care and unstructured minimal preconception lifestyle advice Routine care + a booklet about a French national nutrition and health programme dedicated to pregnancy Intervention: combination Routine care + multi‐disciplinary assessment to establish a baseline periconceptional profile + 2 to 3 tailored objectives on lifestyle negotiated with the couple if necessary: consultation with a psychiatrist, then psychologist follow‐up if required and needed. Addiction specialist physician consultation, then liaison nurse follow‐up if required. Endocrinologist consultation, then dietician follow‐up (3‐month supervised diet programme on web platform) if required. Actiphysician consultation and follow‐up (3‐month personalised PA programme on web platform) if required + personalized follow‐up from the multi‐disciplinary consultation |
Outcomes | Reported behavioural changes in weight (BMI in kg/m²) and physical activity (measured with IPAQ); clinical pregnancy (evidence of gestational sac on ultrasound exam at 6 weeks (primary outcome) measured at the first ART attempt 3 to 12 months after initial visit) |
Starting date | January 2018 |
Contact information | charlotte.dupont@aphp.fr; rachel.levy@aphp.fr |
Notes |
Status of study: ongoing: study author replied by email 19 January 2020 that PEPCI was still ongoing, and that no data are available that can be included in this review at this point. Estimated study completion data on clinicaltrials.gov is November 2021 Other notes: additional outcomes described in the protocol but not on clinical trials.gov, including reported behavioural changes in diet (dietary intake measured with SUVIMAX Questionnaire); quality of life (measured with Duke Questionnaire), and male factor infertility outcomes |