Weight Loss on IVF Outcomes in Overweight and Obese Infertile Women: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Rate of participants with live birth
研究概览
简要总结
The aim of this study is to determine whether weight loss prior to in vitro fertilization (IVF) improves live birth outcomes in overweight and obese infertile women. The study prospectively analyzed 158 overweight and obese (BMI ≥ 24 kg/m2) infertile women, age between 20 and 36 years, undergoing their first assisted reproduction treatment at the Reproductive Center of Peking University People's Hospital from January 2019 to December 2020. They were randomly allocated to two groups: one for weight loss intervention(dietary and exercise management) for 3 months prior to IVF and the other for control. All patients underwent standard ovarian stimulation, oocyte retrieval, and embryo transfer according to the local reproductive center protocol. Statistical analyses included descriptive statistics, logistic regression, and ROC curve analysis
详细描述
Background: Elevated body mass index (BMI) is associated with poorer outcomes in infertile women undergoing assisted reproductive technology (ART). However, evidence for effective weight loss interventions and their impact on live birth rates remains limited and inconclusive. The aim of this study is to determine whether weight loss prior to in vitro fertilization (IVF) improves live birth outcomes in overweight and obese infertile women.
Methods: This randomized controlled clinical trial enrolled 158 overweight or obese (BMI ≥ 24 kg/m²) infertile women undergoing their first ART cycle at the Reproductive Center of Peking University People's Hospital. Participants were randomly allocated to either a weight intervention group or a control group using a computer-generated randomization sequence. The intervention group received a structured program consisting of dietary modification and physical exercise for three months prior to the initiation of IVF. In contrast, the control group received standard clinical care and were advised to manage their weight independently. The primary outcome measure was the live birth rate.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Overweight and obese infertile women attending the Reproductive Centre of Peking University People's Hospital for their first ART from January 2019 to December 2020
排除标准
- •Women were excluded from enrolment if they had concomitant endocrine abnormalities, chromosomal abnormalities affecting pregnancy outcome, history of previous ovarian surgery, or malformed uterus.
研究组 & 干预措施
weight loss intervention
The weight loss intervention group received dietary and exercise interventions for 3 months prior to the start of IVF, including: intake of low glycemic index (GI) foods; a daily net energy expenditure of 500-750 Kcal; adherence to a weekly schedule of moderate-intensity exercise 3-5 times. After 3 months, weight maintenance management continued in accordance with the patients' preferences.
干预措施: weight loss (Behavioral)
control
The control group, with standard clinical care, managed their weight independently before undergoing IVF.
结局指标
主要结局
Rate of participants with live birth
时间窗: From Day 0 of the first embryo transfer cycle (cycle length: 28 days) through the entire pregnancy period until delivery, including both preterm and full-term births
Live birth rate in overweight and obese infertile patients undergoing their first embryo transfer cycle, including premature and full-term birth
Rate of participants with live birth
时间窗: From Day 0 of the first embryo transfer cycle (cycle length: 28 days) through the entire pregnancy period until delivery, including both preterm and full-term births
Live birth rate in overweight and obese infertile patients undergoing their first embryo transfer cycle, including premature and full-term birth
次要结局
未报告次要终点
研究者
Fu Min
Principal Investigator
Peking University People's Hospital