Short Term Weight Loss With Liraglutide and Metformin Before IVF in Infertile Obese PCOS Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The main outcome was change in BMI
研究概览
简要总结
The aim of this study was to evaluate the impact of short-term weight reduction achieved with 12-week intervention with metformin alone or in combination with liraglutide on oocyte maturity and embryo quality in infertile obese PCOS population.
详细描述
Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in particular when PCOS is linked to obesity. Obese PCOS has poor IVF outcomes associated with impaired oocyte and embryo parameters and morphology. The purpose of this pilot prospective study was to investigate the effect of the antiobesity medical therapy (combination of metformin and liraglutide (COMBI)) on short time weight loss in the specific infertile obese PCOS population. Additionally, we analyzed eventual impact of the short term weight loss 5% or more before IVF on oocyte maturity and embryo quality in infertile obese PCOS population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •polycystic ovary syndrome (rotterdam criteria)
- •BMI of 30 kg/m² or higher
- •Infertility for IVF with normal male sperm
排除标准
- •type 1 or type 2 diabetes mellitus
- •history of carcinoma
- •Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
- •personal or family history of multiple endocrine neoplasia 2
- •significant cardiovascular, kidney or hepatic disease
- •the use of medications known or suspected to affect reproductive or metabolic functions
- •the use of statins, within 90 days prior to study entry
研究组 & 干预措施
COMBI group
Drug: liraglutide + metformin
干预措施: Metformin (Drug)
metformin group
Drug: metformin
干预措施: Metformin (Drug)
COMBI group
Drug: liraglutide + metformin
干预措施: Liraglutide + metformin (Drug)
结局指标
主要结局
The main outcome was change in BMI
时间窗: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial.
次要结局
- Impact of the short term weight loss 5% or more before IVF on oocyte maturity in infertile obese PCOS population.(patients were introduced to IVF one month after completed weight loss therapy)
- Impact of the short term weight loss 5% or more before IVF on oocyte number of blastocysts in infertile obese PCOS population.(patients were introduced to IVF one month after completed weight loss therapy)
研究者
Andrej Janez
professor, MD, PhD
University Medical Centre Ljubljana