Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jul 30;9(7):e029665.
doi: 10.1136/bmjopen-2019-029665.

Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT)

Tessy Boedt  1   2 , Eline Dancet  2   3 , Sharon Lie Fong  2 , Karen Peeraer  2   3 , Diane De Neubourg  4 , Sofie Pelckmans  5 , Arne van de Vijver  6 , Jan Seghers  7 , Katleen Van der Gucht  8   9 , Ben Van Calster  3   10 , Carl Spiessens  2   3 , Christophe Matthys  1   11
Affiliations

Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT)

Tessy Boedt et al. BMJ Open. .

Abstract

Introduction: Infertility and in vitro fertilisation (IVF; with or without intracytoplasmic sperm injection) result in considerable emotional and financial burden. Increasing evidence suggests that lifestyle factors, including diet, physical activity and personal well-being, are associated with IVF-success rates. Currently, IVF is not routinely combined with a lifestyle programme. The preconception lifestyle (PreLiFe) randomised controlled trial (RCT) assesses the effects of a new mobile PreLiFe programme in couples undergoing IVF.

Methods and analysis: A multicentre RCT including 460 heterosexual couples starting IVF in Belgian fertility clinics. IVF couples are randomised between an attention control group or the PreLiFe programme for a period of 12 months or until an ongoing pregnancy is confirmed by ultrasound. The attention control programme includes a mobile application with treatment information (ie, appointments and medication instructions) in addition to standard care. The PreLiFe programme includes a mobile application with the same treatment information in combination with a lifestyle programme. This new lifestyle programme includes tailored advice and skills training on diet, physical activity and mindfulness in combination with text messages and telephone interaction with a healthcare professional trained in motivational interviewing. The primary outcome of this RCT is the cumulative ongoing pregnancy rate within 12 months after randomisation. Secondary outcomes include changes in diet, physical activity, emotional distress, body mass index, waist circumference, quality of life and other reproductive outcomes including IVF discontinuation, clinical pregnancy rate and time to pregnancy. Additionally, partner support and the feasibility (use and acceptability) of the PreLiFe programme will be evaluated in the intervention group. Analysis will be according to intention to treat.

Ethics and dissemination: This study has been approved by the Medical Ethical Committee of the Leuven University Hospital (Belgium) and the other recruiting clinics. The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications.

Trial registration number: NCT03790449; Pre-results.

Keywords: IVF; diet; fertility treatment; infertility; lifestyle; mHealth; mindfulness; physical activity; reproductive outcome.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Overview of PreLiFe-RCT. BMI, body mass index; IVF, in vitro fertilisation; QOL, quality of life; RCT, randomised controlled trial.
See this image and copyright information in PMC

References

    1. Boivin J, Bunting L, Collins JA, et al. International estimates of infertility prevalence and treatment-seeking: potential need and demand for infertility medical care. Hum Reprod 2007;22:1506–12. 10.1093/humrep/dem046 - DOI - PubMed
    1. Wu AK, Elliott P, Katz PP, et al. Time costs of fertility care: the hidden hardship of building a family. Fertil Steril 2013;99:2025–30. 10.1016/j.fertnstert.2013.01.145 - DOI - PMC - PubMed
    1. Gameiro S, Boivin J, Peronace L, et al. Why do patients discontinue fertility treatment? A systematic review of reasons and predictors of discontinuation in fertility treatment. Hum Reprod Update 2012;18:652–69. 10.1093/humupd/dms031 - DOI - PMC - PubMed
    1. De Neubourg D, Bogaerts K, Blockeel C, et al. How do cumulative live birth rates and cumulative multiple live birth rates over complete courses of assisted reproductive technology treatment per woman compare among registries? Hum Reprod 2016;31:93–9. 10.1093/humrep/dev270 - DOI - PubMed
    1. Peeraer K, Debrock S, Laenen A, et al. The impact of legally restricted embryo transfer and reimbursement policy on cumulative delivery rate after treatment with assisted reproduction technology. Hum Reprod 2014;29:267–75. 10.1093/humrep/det405 - DOI - PubMed

Publication types

Associated data

LinkOut - more resources