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Clinical Trial Protocol Journal Article Epublish 9 citations

PubMed: 32456614 DOI: 10.1186/s12884-020-2855-9

Effectiveness of a therapeutic multiple-lifestyle intervention taking into account the periconceptional environment in the management of infertile couples: study design of a randomized controlled trial - the PEPCI study.

BMC Pregnancy Childbirth 20(1):322

Authors: Charlotte Dupont, Philippe Aegerter, Aude-Marie Foucaut, Aymeric Reyre, François J Lhuissier, Marie Bourgain, Nathalie Chabbert-Buffet, Isabelle Cédrin-Durnerin, Lise Selleret, Emmanuel Cosson, Rachel Lévy

Affiliations

  • Saint Antoine Research Center, INSERM équipe Lipodystrophies génétiques et acquises, Service de biologie de la reproduction-CECOS, AP-HP, Hôpital Tenon, Sorbonne Université, 4 rue de la Chine, F-75020, Paris, France.
  • Unité de Recherche Clinique et Département de Santé Publique, Assistance Publique - Hôpitaux de Paris, Hôpital Ambroise Paré, Boulogne, France.
  • UVSQ, UMR-S 1168 Université de Versailles Saint Quentin Paris Saclay, INSERM VIMA Aging and Chronic diseases, Epidemiological and Public Health approaches, Paris, France.
  • Université Sorbonne Paris Nord, Laboratoire Educations et Pratiques de Santé, LEPS, UR 3412, F-93017, Bobigny, France.
  • Département STAPS, Université Sorbonne Paris Nord, Bobigny, France.
  • Department of Addiction Medicine and Psychiatry, APHP Avicenne University Hospital, Bobigny, France.
  • CESP-INSERM U1178, Villejuif, France.
  • Université Sorbonne Paris Nord, UMR INSERM 1272 Hypoxie et poumon, Bobigny, France.
  • Assistance Publique - Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Jean Verdier, Médecine de l'exercice et du sport, Bondy, France.
  • Service de Gynécologie-Obstétrique et Médecine de La Reproduction, APHP Hôpital Tenon, 4 Rue de La Chine, 75020, Paris, France.
  • APHP Hôpital Jean verdier Service de médecine de la reproduction et préservation de la fertilité, avenue du 14-Juillet, 93143, Bondy, France.
  • Paris 13 University, Sorbonne Paris Cité, Assistance Publique - Hôpitaux de Paris, Avicenne Hospital, Department of Endocrinology-Diabetology-Nutrition, CRNH-IdF, CINFO, Bobigny, France.
  • Paris 13 University, Sorbonne Paris Cité, UMR U557 INSERM/U11125 INRA/CNAM/Université Paris13, Unité de Recherche Epidémiologique Nutritionnelle, Bobigny, France.
  • Saint Antoine Research Center, INSERM équipe Lipodystrophies génétiques et acquises, Service de biologie de la reproduction-CECOS, AP-HP, Hôpital Tenon, Sorbonne Université, 4 rue de la Chine, F-75020, Paris, France.

Abstract

BACKGROUND

Infertility is defined as the inability to conceive after 12 months of unprotected intercourse. It affects approximately one in six couples seeking pregnancy in France or western countries. Many lifestyle factors of the couples' pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee, drugs, physical activity, stress, sleep…) have been identified as risk factors for infertility in both males and females. The high prevalence rates of unhealthy diets and lifestyles in the reproductive population of industrialized countries are worrisome. Nevertheless, adoption of a healthy lifestyle may improve fertility but lifestyle changes are difficult to achieve and to maintain due notably to behavioral factors.

METHODS

Consequently, we decided to propose an interventional study aimed at improving the quality of life of infertile couples before the start of assisted reproductive technology treatment. It is a randomized controlled multicentre trial. Both members of the couples are involved in an integrated global care program (PEPCI for "Parcours Environnement PériConceptionnel en Infertilité") vs. usual care. This global intervention not only considers diet and/or physical activity but follows a holistic approach, including a multidisciplinary assessment to address complete physical, psychological and social well-being. According to patient needs, this includes interventions on weight, exercise, diet, alcohol and drugs, mental and social health.

DISCUSSION

The main objective of trial is to demonstrate that periconceptional multidisciplinary care has a positive impact on reproductive functions. We will also focus on feasibility, acceptance, compliance and conditions of success of a multifaceted lifestyle intervention.

TRIAL REGISTRATION

The trial was registered at ClinicalTrials.gov, Identifier: NCT02961907 on November 11, 2016.

MeSH

Exercise, Pregnancy, Life Style, Fertility, Pharmaceutical Preparations, Diet, Therapeutics, Environment

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