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InfertilityPreLiFe-RCTNCT03790449

Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing In Vitro Fertilisation

A study testing PreLiFe-programme in people with Infertility, run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Infertility
What is being tested?
PreLiFe-programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
5 sitesBelgium
Study dates
2 Jan 2019to 13 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Belgium5 sites

  • University Hospital Antwerp

    Antwerp, 2000

  • Imelda Hospital Bonheiden

    Bonheiden, 2820

  • Academic Hospital Sint Jan Bruges-Ostend

    Bruges, 8000

  • Academic Hospital Diest

    Diest, 3290

  • University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing in Vitro Fertilisation: a Multicentre Randomized Controlled Trial (PreLiFe-RCT)

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.

Read the 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.

Conditions
Infertility
Being tested
PreLiFe-programme, Attention Control Programme
Keywords
Infertility, Lifestyle, mobile health, Diet, Physical Activity, Mindfulness
Medical subject headings
Infertility, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PreLiFe-programmeBehavioural

    The intervention group will receive a mobile preconception lifestyle programme (the PreLiFe-programme) in addition to standard care for 12 months or until an ongoing pregnancy is confirmed by ultrasound. The PreLiFe-programme includes a mobile application (PreLiFe-app) with the same treatment information as the attention control group in combination with a lifestyle programme. This new lifestyle programme includes tailored advice and skills training on diet and physical activity and mindfulness exercises. Additionally couples will be offered interaction with a health care provider through text messages and telephone interaction following the concept of blended care.

  • Attention Control ProgrammeBehavioural

    The standard care serving as control for this intervention is fertility treatment i.e. IVF with or without ICSI according to local protocols for infertility patients. This implies no guidance on lifestyle. However, to have attention control the control group will receive an attention control programme. The attention control programme includes a mobile application (app) with treatment information including medication instructions, reminders of injection of human Chorionic Gonadotropin (hCG) and time of fertility treatment appointments for 12 months or until an ongoing pregnancy is confirmed by ultrasound.

Study groups in NCT03790449
Study groupRoleWhat they receive
PreLiFe-programmeExperimentalA Mobile Preconception Lifestyle programme
Receives: Behavioral: PreLiFe-programme; Behavioral: Attention Control Programme
Attention ControlOtherAttention Control Programme
Receives: Behavioral: Attention Control Programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation

    Ongoing pregnancy is defined as a viable intrauterine pregnancy of at least 12 weeks duration confirmed on ultrasound scan. All pregnancies (Spontaneous and IVF pregnancies) conceived within these 12 months are followed up until the 12 weeks ultrasound scan. IVF-discontinuation is described as couples undergoing IVF who do not return for a further IVF cycle in our fertility centres after the failure of a previous cycle. Ongoing pregnancy within 12 months after randomisation is counted as a positive event, whereas IVF discontinuation and absence of pregnancy are counted as a negative event. Differences in COPR will be evaluated between the intervention and attention control group.

    Measured: 12 months

Secondary outcomes (8)

  1. Changes in diet assessed with a Food Frequency Questionnaire (FFQ)

    A validated food frequency questionnaire (FFQ) is used to evaluate changes in dietary pattern and diet quality over time and to evaluate differences in the dietary pattern and diet quality between the intervention and attention control group. The FFQ consists of a finite list of foods and beverages with response categories to indicate usual frequency and portion size of consumption over the last month. Diet quality is calculated from the FFQ by assessing quality, balance and variety of foods and beverages consumed (score 0-100 with the higher the better diet quality). Diet quality is an index to reflect compliance with the Belgian Food Based Dietary Guidelines.

    Measured: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

  2. Changes in physical activity assessed with the International Physical Activity Questionnaire (IPAQ)

    The International Physical Activity Questionnaire Short Form (IPAQ-SF) is used to evaluate changes in physical activity over time and to evaluate differences in physical activity between the intervention and attention control group. The IPAQ-SF assesses the duration (in minutes) and frequency (in days) of walking, moderate-intensity activities, vigorous-intensity activities and sedentary activity (sitting) based on metabolic equivalent (MET) values. Self-reported physical activity is classified as low, moderate or high physically active based on the global recommendations on physical activity for health of the World Health Organisation. The IPAQ-SF is a reliable and validated instrument for monitoring physical activity in population health surveillance systems.

    Measured: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

  3. Changes in symptoms of emotional distress, anxiety and depression (personal wellbeing) assessed with the Depression, anxiety and stress scale (DASS-21)

    The Depression, anxiety and stress scale (DASS-21) is used to evaluate changes in personal wellbeing over time and to evaluate differences in personal wellbeing between the intervention and attention control group. Self-reported symptoms of stress, anxiety and depression (together emotional distress) are measured with this validated scale (score 0-126 with the lower, the higher personal wellbeing).

    Measured: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

  4. Changes in fertility related quality of life assessed with the Fertility Quality of Life Tool (FERTIQOL).

    The Fertility Quality of Life Tool (FERTIQOL) is used to evaluate changes in fertility related quality of life over time and to evaluate differences in fertility related quality of life between the intervention and attention control group. Self-reported fertility related quality of life is measured with this validated scale (score 0-100 with the higher, the better fertility related quality of life).

    Measured: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

  5. Changes in Body Mass Index (BMI)

    Weight and height are measured according to International Standards for Anthropometric Assessment. Weight is measured when wearing light clothes and no shoes on a calibrated scale. Height is measured without shoes on a stadiometer. Weight and height allow body mass index (BMI) calculation. Changes in BMI over time and differences in BMI between the intervention and attention control group are evaluated.

    Measured: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

  6. Changes in waist circumference measured with a measuring tape

    Waist circumference is measured according to International Standards for Anthropometric Assessment with a SECA measuring tape to estimate abdominal fat. Changes in waist circumference over time and differences in waist circumference between the intervention and attention control group are evaluated.

    Measured: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

  7. Number of clinical pregnancies

    Clinical pregnancy defined as evidence of a gestational sac confirmed by ultrasound. Dichotomous outcome (yes-no). Differences in number of clinical pregnancies between the intervention and attention control group are evaluated.

    Measured: 12 months

  8. Time to pregnancy

    Differences in time to pregnancy between the intervention and attention control group are evaluated.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2018
  2. Study start2 Jan 2019
  3. Primary completion13 Jun 2020
  4. Study completion13 Mar 2021

Why it stopped: Due to the worldwide Covid-19 pandemic, all Belgian fertility clinics stopped offering IVF as of March 13th 2020. We had to stop recruitment and follow-up of study subjects. We therefore adjusted our primary outcome to time to ongoing pregnancy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial (1:1)
Masking
None (open label)
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03790449
Sponsor's protocol ID
s61596
Acronym
PreLiFe-RCT
Status last verified
May 2021
First submitted
12 Nov 2018
Last updated
10 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For all the data generated during the course of this project, we will follow the prevailing standards and guidelines in documenting and depositing data sets. The PreLiFe research team will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. Regarding data sharing, ICMJE recommendations will be followed. Individual deidentified participant data will be shared. In particular, individual participant data that underlie the results reported in our articles, after deindentification (text, tables, figures and appendices).

Publications

  • Boedt T, Dancet E, De Neubourg D, Vereeck S, Jan S, Van der Gucht K, Van Calster B, Spiessens C, Lie Fong S, Matthys C. A blended preconception lifestyle programme for couples undergoing IVF: lessons learned from a multicentre randomized controlled trial. Hum Reprod Open. 2023 Sep 29;2023(4):hoad036. doi: 10.1093/hropen/hoad036. eCollection 2023.

    PubMed 38455033

  • 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.

    PubMed 34379119

  • 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.

    PubMed 31366659

Questions about this trial

What is this clinical trial studying?

A study testing PreLiFe-programme in people with Infertility, run by Universitaire Ziekenhuizen KU Leuven at 5 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to the worldwide Covid-19 pandemic, all Belgian fertility clinics stopped offering IVF as of March 13th 2020. We had to stop recruitment and follow-up of study subjects. We therefore adjusted our primary outcome to time to ongoing pregnancy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03790449, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021; AzTrials last refreshed its copy on 2 Nov 2026.

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