Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing in Vitro Fertilisation: a Multicentre Randomized Controlled Trial (PreLiFe-RCT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 211
- 试验地点
- 5
- 主要终点
- Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Statistician is blinded
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PreLiFe-programme
A Mobile Preconception Lifestyle programme
干预措施: PreLiFe-programme (Behavioral)
PreLiFe-programme
A Mobile Preconception Lifestyle programme
干预措施: Attention Control Programme (Behavioral)
Attention Control
Attention Control Programme
干预措施: Attention Control Programme (Behavioral)
结局指标
主要结局
Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation
时间窗: 12 months
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.
次要结局
- Changes in fertility related quality of life assessed with the Fertility Quality of Life Tool (FERTIQOL).(at baseline, 3 months, 6 months, 9 months and 12 months after randomisation)
- Changes in waist circumference measured with a measuring tape(at baseline, 3 months, 6 months, 9 months and 12 months after randomisation)
- Changes in diet assessed with a Food Frequency Questionnaire (FFQ)(at baseline, 3 months, 6 months, 9 months and 12 months after randomisation)
- Changes in symptoms of emotional distress, anxiety and depression (personal wellbeing) assessed with the Depression, anxiety and stress scale (DASS-21)(at baseline, 3 months, 6 months, 9 months and 12 months after randomisation)
- Changes in Body Mass Index (BMI)(at baseline, 3 months, 6 months, 9 months and 12 months after randomisation)
- Number of clinical pregnancies(12 months)
- Changes in physical activity assessed with the International Physical Activity Questionnaire (IPAQ)(at baseline, 3 months, 6 months, 9 months and 12 months after randomisation)
- Time to pregnancy(12 months)