The Combination of Myoinositol, L-arginine and Chromium With Letrozole for Ovulation Induction in Polycystic Ovarian Syndrome Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- ovulation
研究概览
简要总结
The aim of the study is to compare and assess the efficacy of combined letrozole with myoinositol, chromium, or L-arginine in infertile women with PCOS. This study will help in the investigation of alternative therapeutic modalities for fertility improvement in polycystic ovarian syndrome
详细描述
d prospective Study Trial. We will recruit patients diagnosed with PCOS according to Rotterdam criteria of PCOS and who present to outpatient clinics at Beni-Suef University Hospital. Infertile women will be randomized to receive letrozole (2.5 mg for 5 days from 3rd day of patients' menstrual cycle) combination with myoinositol, chromium or L-arginine
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary infertility associated with PCOS as defined by the revised Rotterdam criteria
- •Normal values of the following laboratory tests: thyroid function, prolactin level, and husband's sperm analysis and hysterosalpingography
排除标准
- •Patients with a history of systemic diseases such as liver, kidney, cardiovascular, diabetes (type I or II) or malignancy.
- •Patients who consumed myoinositol, metformin, SGLT2 or drugs effecting insulin secretion or clomiphene citrate in the previous 2 months.
- •Use of hormonal medications, lipid-lowering agents (statins, etc.), anti-obesity drugs or medications for weight loss in the previous 2 months.
- •Patients with hormonal disorders such as hyperprolactinemia, hypo or hyperthyroidism or Cushing syndrome.
- •Presence of hypersensitivity to any of the study medications.
研究组 & 干预措施
myoinositol
patients will be treated for 12 weeks myoinositol (2gm /day) with ovulation induction by letrazole regimen for 3 consecutive cycl
干预措施: Myoinositol (Drug)
myoinositol
patients will be treated for 12 weeks myoinositol (2gm /day) with ovulation induction by letrazole regimen for 3 consecutive cycl
干预措施: Letrozole 2.5mg (Drug)
chromium
patients will be treated for 12 weeks chromium ( 281.569 mcg/ day) with ovulation induction by letrazole regimen for 3 consecutive cycles
干预措施: Chromium (Drug)
chromium
patients will be treated for 12 weeks chromium ( 281.569 mcg/ day) with ovulation induction by letrazole regimen for 3 consecutive cycles
干预措施: Letrozole 2.5mg (Drug)
L-arginine
: patients will be treated for 12 weeks with L-arginine (500 mg once daily in the morning) with ovulation induction by letrazole regimen for 3 consecutive cycles.
干预措施: l-arginine (Drug)
L-arginine
: patients will be treated for 12 weeks with L-arginine (500 mg once daily in the morning) with ovulation induction by letrazole regimen for 3 consecutive cycles.
干预措施: Letrozole 2.5mg (Drug)
结局指标
主要结局
ovulation
时间窗: 3 cycles ( 3 months / one month for each cycle)
trans-vaginal ultrasound shows dominant follicle more than 18mm
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University