Clinical trial NCT03790449: Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing In Vitro Fertilisation
Official title: Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing in Vitro Fertilisation: a Multicentre Randomized Controlled Trial (PreLiFe-RCT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Lifestyle
mobile health
Diet
Physical Activity
Mindfulness
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: KU Leuven
name: University Hospital, Antwerp
First posted: 2018-12-31
Enrollment: 211
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (1:1)
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the PreLiFe RCT is to assess the effects of a new mobile preconception lifestyle programme (PreLiFE-programme) for couples undergoing IVF. Couples about to start IVF will be randomized between an attention control programme or the PreLiFe-programme for 12 months or until an ongoing pregnancy is confirmed by ultrasound.This study will examine whether the PreLiFe-programme results in a higher cumulative ongoing pregnancy rate within 12 months as compared to an attention control programme. Secondary outcomes include changes in diet, physical activity, personal wellbeing, body mass index, waist circumference, quality of life and other reproductive outcomes including clinical pregnancy and time to pregnancy. Additionally, the partners' support and the feasibility of the PreLiFe-programme will be evaluated.

Detailed description: Introduction: Infertility and in vitro fertilization (IVF; with or without intracytoplasmic sperm injection, ICSI) result in considerate emotional and financial burden. Increasing evidence suggests that lifestyle factors, including diet, physical activity and personal wellbeing, are associated with IVF-success rates. So far, IVF is not routinely combined with a lifestyle programme. The PreLiFe randomized controlled trial (RCT) will assess the effects of a new mobile preconception lifestyle programme (PreLiFe-programme) in couples undergoing IVF.

Methods and analysis: A multicentre RCT will include heterosexual couples about to start IVF (with or without ICSI) in Belgian fertility clinics. IVF-Couples will be randomized between an attention control programme or the PreLiFe-programme for 12 months or until an ongoing pregnancy is confirmed by ultrasound. The attention control programme includes a mobile application with treatment information (i.e. 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 on diet and physical activity and mindfulness exercises in combination with text messages and telephone interaction with a lifestyle coach. 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, personal wellbeing, body mass index, waist circumference and quality of life measured with self-reported questionnaires and physical assessments and changes in other reproductive outcomes including clinical pregnancy and time to pregnancy. Additionally, the partners' support and the feasibility (use and acceptability) of the PreLiFe-programme will be evaluated using self-reported questionnaires and app-based tracking. 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 of the other recruiting clinics. The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications.

Due to the worldwide Covid-19 pandemic, we had to stop recruiting new patients and stop studying patients who were in the midst of their 12 months study period. This was inevitable as all Belgian fertility clinics stopped offering IVF as of March 13th 2020 for a (not predefined) period. Patients who had been randomized, but were still ongoing in the trial at that time needed to be censored. Based on statistical advise, we changed therefore our primary outcome analysis from cumulative ongoing pregnancy rate within 12 months after randomisation to time to ongoing pregnancy in order to be able to use the data of the many study patients who were in the midst of their 12 months study period.

Eligibility criteria: Inclusion Criteria:

* Infertile heterosexual couples about to start a first IVF-cycle (with or without ICSI) with infertility defined as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse
* Women of couples aged ≤ 38 years
* Both partners possess a smartphone
* Both partners understand and speak Dutch
* Written informed consent after been informed on all aspects of the study

Exclusion Criteria:

* Couples with previous IVF/ICSI treatment cycles
* Couples where one of the partners has special dietary requirements including but not limited to patients that underwent bariatric surgery, patients with coeliac disease or renal disease
* Couples where one of the partners has specific movement's constraints including but not limited to patients with cerebral palsy or hemiparesis
* Couples starting IVF/ICSI with preimplantation genetic diagnosis (PGD)
* Couples using donor gametes or donor embryos

Primary outcomes:
measure: Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation
timeFrame: 12 months
Secondary outcomes:
measure: Changes in diet assessed with a Food Frequency Questionnaire (FFQ)
timeFrame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation
measure: Changes in physical activity assessed with the International Physical Activity Questionnaire (IPAQ)
timeFrame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation
measure: Changes in symptoms of emotional distress, anxiety and depression (personal wellbeing) assessed with the Depression, anxiety and stress scale (DASS-21)
timeFrame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation
measure: Changes in fertility related quality of life assessed with the Fertility Quality of Life Tool (FERTIQOL).
timeFrame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation
measure: Changes in Body Mass Index (BMI)
timeFrame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation
measure: Changes in waist circumference measured with a measuring tape
timeFrame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation
measure: Number of clinical pregnancies
timeFrame: 12 months
measure: Time to pregnancy
timeFrame: 12 months
Other outcomes:
measure: Use of the PreLiFe-programme assessed with app based tracking
timeFrame: at 3 months, 6 months, 9 months and 12 months after randomisation
measure: Acceptability of the PreLiFe-programme assessed with a subscale of the Mobile App Rating Scale (MARS)
timeFrame: 12 months
measure: Partners' support assessed with a questionnaire
timeFrame: at 3 months, 6 months, 9 months and 12 months after randomisation
measure: Occurrence of adverse events
timeFrame: 12 months
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Bonheiden
country: Belgium
facility: Imelda Hospital Bonheiden
city: Bruges
country: Belgium
facility: Academic Hospital Sint Jan Bruges-Ostend
city: Diest
country: Belgium
facility: Academic Hospital Diest
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: KU Leuven, UZ Leuven
name: Sharon Lie Fong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boedt T, Matthys C, Lie Fong S, De Neubourg D, Vereeck S, Seghers J, Van der Gucht K, Weyn B, Geerts D, Spiessens C, Dancet EAF. Systematic development of a mobile preconception lifestyle programme for couples undergoing IVF: the PreLiFe-programme. Hum Reprod. 2021 Aug 18;36(9):2493-2505. doi: 10.1093/humrep/deab166.
citation: Boedt T, Dancet E, Lie Fong S, Peeraer K, De Neubourg D, Pelckmans S, van de Vijver A, Seghers J, Van der Gucht K, Van Calster B, Spiessens C, Matthys C. Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT). BMJ Open. 2019 Jul 30;9(7):e029665. doi: 10.1136/bmjopen-2019-029665.