Sodium-Glucose Co-Transporter-2 Inhibitors as Adjuvant Therapy With Letrozole in Induction of Ovulation in Women With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Pregnancy
研究概览
简要总结
The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.
详细描述
The study will be a randomized controlled clinical trial. Once the eligibility from screening visit is determined prior to baseline visit, randomization will be made by computer randomization for women who are admitted to Beni-Suef University Hospital.
- Before initiation of the study, the population will be divided randomly into 4 equal groups: group A, B, C and D. The adjuvant therapy of each group will be group (A) Metformin 1000mg, group (B) Dapagliflozin 10mg, Group(C) Combined Dapagliflozin-Metformin 10/1000mg and group (D) with no adjuvant therapy (control group).
- The adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole. All groups will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.
This treatment regimen will continue for three cycles unless positive pregnancy is achieved. No diet restriction will be recommended during the study or change in the lifestyle. The population will be asked to inform about any side effects that may happen during the study. A written informed consent will be obtained from each woman participating in the study.
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
- •PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met:
- •oilgo and/or anovulation (infrequent or no ovulation),
- •clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels
- •polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml).
排除标准
- •Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
- •Persistent hyperprolactinemia,
- •thyroid dysfunction defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL)
- •patients with menopausal levels of FSH (> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
- •Liver disease is defined as AST or ALT > 2 times normal or total bilirubin >2.5 mg/dL, #kidney disease defined as BUN > 30 mg/dL or serum creatinine> 1.4 mg/dL or significant
研究组 & 干预措施
Dapagliflozin-Metformin 10/1000mg
干预措施: Dapagliflozin/Metformin (Drug)
Metformin 1000mg
干预措施: Metformin (Drug)
Metformin 1000mg
干预措施: Letrozole (Drug)
Dapagliflozin 10mg
干预措施: Dapagliflozin (Drug)
Dapagliflozin 10mg
干预措施: Letrozole (Drug)
Dapagliflozin-Metformin 10/1000mg
干预措施: Letrozole (Drug)
结局指标
主要结局
Pregnancy
时间窗: 3 cycles ( 3 months / one month for each cycle)
Serum HCG positive
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