The Effect of Liraglutide on Pregnancy Rates in Obese Women With PCOS Undergoing in Vitro Fertilization: a Pilot Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- IVF pregnancy rates
研究概览
简要总结
The aim of this study was to evaluate the impact of low dose liraglutide in combination with metformin compared to metformin alone on IVF pregnancy rate (PR) and cumulatively PR (IVF and spontaneous) in infertile obese women with PCOS who had been previously poor responders regarding weight reduction with lifestyle modification and resistant to first line reproductive treatments.
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 novel medical therapy (combination of metformin and liraglutide (COMBI)) in the specific infertile obese PCOS population. GLP-1 has been investigated in regulation of reproductive system in animal models. Current observations suggest that it directly regulates kisspeptin and GnRH expression and that ovaries express GLP-1 mRNA. In obese PCOS, GLP-1 receptor agonist liraglutide provided positive effects on weight reduction and glucose homeostasis
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 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old to 38 years old
- •polycystic ovary syndrome (rotterdam criteria)
- •BMI of 30 kg/m² or higher
- •Infertility
- •Before IVF
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 MEN 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 no other ovarian pathology normal male semen
研究组 & 干预措施
Metfrormin group (MET)
Drug: Metformin
干预措施: MET (Drug)
COMBI group (COMBI)
Drug: liraglutide
干预措施: COMBI (Drug)
结局指标
主要结局
IVF pregnancy rates
时间窗: 14 days
Clinical pregnancy rate defined as the presence of a fetal heart beat by ultrasound
BMI
时间窗: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial. ]
Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
Cumulative pregnancy rates
时间窗: The pregnancies were collected by phone interview after one year
Number of all pregnancies (IVF pregnancies and spontaneous pregnancies) per patient
次要结局
- Oocyte nuclear maturation(2 days)
- Embryo quality(6 days)
研究者
Vesna Salamun
MD
University Medical Centre Ljubljana