Weight Management Intervention for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF)
2018年9月5日 更新者：Ann Thurin Kjellberg、Sahlgrenska University Hospital, Sweden
Weight Management Interventions for Obese Women and the Live Birth Outcome of in Vitro Fertilization (IVF): a Randomized Controlled Trial
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.
研究概览
详细说明
There will be two groups of patients.
- 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.
- 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.
- 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.
研究类型
介入性
注册 (实际的)
317
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Copenhagen、丹麦
- Rigshospitalet
-
Copenhagen、丹麦
- Herlev Hospital
-
Copenhagen、丹麦
- Hvidovre Hospital
-
Holbaek、丹麦
- Holbaek Hospital
-
-
-
-
-
Reykjavik、冰岛
- ART Medica
-
-
-
-
-
Göteborg、瑞典
- Sahlgrenska University Hospital
-
Malmö、瑞典
- Skånes universitetssjukhus
-
Stockholm、瑞典
- Karolinska Universitetssjukhuset
-
Örebro、瑞典
- Örebro University Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 37年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion criteria
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：IVF only
IVFtreatment
|
|
|
有源比较器：Weight reduction treatment and IVF
Dietary Supplement: Low calorie diet treatment and then IVFtreatment
|
Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Live birth
大体时间：Approximately 10-16 months after randomization, depending on study group.
|
Live birth per participating woman
|
Approximately 10-16 months after randomization, depending on study group.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
embryology
大体时间：After theIVF-treatment, approximately 1-6 months after randomization
|
number of good quality embryos
|
After theIVF-treatment, approximately 1-6 months after randomization
|
|
obstetric outcomes
大体时间：Approximately 10-16 months after randomization, after delivery
|
obstetric and neonatal data
|
Approximately 10-16 months after randomization, after delivery
|
|
compliance to intervention
大体时间：Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment
|
Compliance to intervention assessed as weight loss during intervention, dietary intake and quality of life
|
Assessed in the intervention group 12-16 weeks after randomization, prior to IVF-treatment
|
|
Husband data
大体时间：before IVF-treatment
|
Measurement of the husband for height, weight and dietary intake and eating patterns correlated to sperm count, sperm motility and sperm chromatin fragmentation
|
before IVF-treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Ann Thurin Kjellberg, MD PhD、Sahlgrenska University Hospital, Sweden
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Svensson H, Einarsson S, Olausson D, Kluge L, Bergh C, Eden S, Lonn M, Thurin-Kjellberg A. Inflammatory and metabolic markers in relation to outcome of in vitro fertilization in a cohort of predominantly overweight and obese women. Sci Rep. 2022 Aug 3;12(1):13331. doi: 10.1038/s41598-022-17612-2.
- Kluge L, Bergh C, Einarsson S, Pinborg A, Mikkelsen Englund AL, Thurin-Kjellberg A. Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial. Hum Reprod Open. 2019 Dec 10;2019(4):hoz030. doi: 10.1093/hropen/hoz030. eCollection 2019.
- Einarsson S, Bergh C, Friberg B, Pinborg A, Klajnbard A, Karlstrom PO, Kluge L, Larsson I, Loft A, Mikkelsen-Englund AL, Stenlof K, Wistrand A, Thurin-Kjellberg A. Weight reduction intervention for obese infertile women prior to IVF: a randomized controlled trial. Hum Reprod. 2017 Aug 1;32(8):1621-1630. doi: 10.1093/humrep/dex235.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年10月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2018年4月1日
研究注册日期
首次提交
2012年3月23日
首先提交符合 QC 标准的
2012年3月27日
首次发布 (估计)
2012年3月30日
研究记录更新
最后更新发布 (实际的)
2018年9月7日
上次提交的符合 QC 标准的更新
2018年9月5日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.