Weight Management Interventions for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 317
- 试验地点
- 11
- 主要终点
- Live birth
研究概览
简要总结
The primary aim of the study is to evaluate if weight management intervention for obese women (BMI≥30<35 kg/m2) prior to IVF improves the outcome assessed as live birth per participating woman, as compared to women where no intervention was made.
详细描述
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There will be two groups of patients.
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The first group (n=167) will receive weight management intervention during up to four months prior to IVF treatment.The group randomized to intervention will start an intensive weight reduction plan. The aim of the weight reduction is to reach as close to normal BMI (<25.0 kg/m2) as possible during a time of approximately 4 months. The purpose of the dietary intervention is to create a negative energy balance to induce weight loss. The intervention starts with 12 weeks of a low calorie liquid formula diet (LCD) and thereafter, diet re-introduction and weight control stabilization until IVF treatment begins. Should the patient for some reason be unable to fulfil the LCD-treatment, she will anyhow have an individualized dietary counselling to help her loose weight until the time for her IVF-treatment.
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The second group (n=167) will start their IVF-treatment directly without other intervention than written advice about the benefits of weight reduction and exercise. The group randomized directly to IVF-treatment will start the treatment as soon as possible after randomization, preferably within that menstrual cycle.
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Tertiary aim is a follow-up 2 years after randomization to the study with questionnaires to the couple in both the intervention and the control groups. A special questionnaire will cover the weights of the couple and if the woman has had any pregnancies or live births after concluding the study. For the women having achieved a live birth in the index-cycle of IVF the number of children and also follow-up of the children will be performed by assessing medical records from pediatric clinic (if applicable) and child health care centres covering birth data, general health and weight of the children at birth and at the assessment date. Eating -habits and -patterns and quality of life parameters will be assessed with the same three questionnaires that were filled in after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Indication for IVF/ICSI for the couple
- •Woman's age >18< 38 years at randomization
- •First, second or third IVF/ICSI treatment
- •BMI > or = 30.0 <35.0 kg/m2
- •Willing to participate and to sign informed consent
排除标准
- •Diabetes mellitus treated with insulin
- •Oocyte or sperm donation planned
- •Preimplantation genetic diagnosis (PGD) treatment planned
- •Azoospermia known at randomization
- •Patient not having adequate knowledge of Swedish (to understand patient information and questionnaires)
- •QEWP-R questionnaire indicating binge eating disorder for the woman
- •Previous participation in the study
结局指标
主要结局
Live birth
时间窗: Approximately 10-16 months after randomization, depending on study group.
Live birth per participating woman
次要结局
- obstetric outcomes(Approximately 10-16 months after randomization, after delivery)
- compliance to intervention(Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment)
- Husband data(before IVF-treatment)
- embryology(After theIVF-treatment, approximately 1-6 months after randomization)
研究者
Ann Thurin Kjellberg
MD, PhD
Sahlgrenska University Hospital