Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Infertile Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cummulative rate of pregnancy
研究概览
简要总结
The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and dapagliflozin as monotherapies and the effect of both of them as a combined therapy in infertile women with PCOs.
详细描述
It is a Prospective randomized controlled trial .The study will include 200 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), according to Rotterdam criteria (BMI≥ 24kg/m, Homeostatic model assessment of insulin resistance (HOMA-IR with cutoff ≥ 2.5 biochemical hyperandrogenism, as indicated by a free androgen index (FAI) >4, and self-reported oligomenorrhea (cycle length >35 days and 9 or fewer periods per year) or amenorrhoea (absence of menses for a period ≥3 months) will be included for the study.
I The study will include four groups; each group consists of 50 patients:-
- Group I (n=50) will be treated by metformin monotherapy.
- Group II (n=50) will be treated by Dapagliflozin monotherapy .
- Group III (n=50) will be treated by metformin and dapagliflozin combined therapy
- Group IV (n=50) will be a control group.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women are aged between 18 and 45 years
- •no pregnancy plan within the next 6 months
- •polycystic ovarian syndrome (PCOS), according to Rotterdam criteria
排除标准
- •congenital adrenal hyperplasia
- •poorly controlled thyroid disease
- •Taking antidiabetic drugs which can affect insulin resistance
- •chronic kidney disease and history of recurrent urinary tract infections
- •liver dysfunction (AST or ALT > 3 times the upper limit of normal or GFR<30 ml/min/1.73m2)
- •documented use of oral hormonal contraceptives and hormone-releasing implants
研究组 & 干预措施
metformin and dapagliflozin combined therapy
Xigduo once daily
干预措施: Dapagliflozin/Metformin (Drug)
metformin monotherapy
Glucophage 1000 once daily
干预措施: Metformin Hydrochloride 1000 MG (Drug)
Dapagliflozin monotherapy .
Farxiga once per day
干预措施: Dapagliflozin 5 MG (Drug)
结局指标
主要结局
Cummulative rate of pregnancy
时间窗: 3 months
HCG test
ovulation
时间窗: 3 cycles ( 3 months / one month for each cycle)
folliculometry by ultrasound
次要结局
- Body weight changes(3 months)
- Fasting blood sugar (FBS)/ 2 hpp(3 months)
- FSH*LH*E2(3 months)
- Total Testosterone (TT)(3 months)
- lipid profile(3 months)
- side effects(3 months)
- Free Androgen Index (FAI)(3 months)
- ALT(3 months)
- changes of Menstrual cycle(3 months)
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University