Comparing the Therapeutic Effect of Sitagliptin/Metformin and Metformin on Biochemical Factors and Expression of GDF-9 and BMP-15 Genes in Patients With Classic PCOS Undergoing Intra-cytoplasmic Sperm Injection (ICSI)
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fasting insulin
研究概览
简要总结
Investigators will evaluate and compare the efficacy of Sitagliptin/Metformin to metformin and sitagliptin on gdf9 and bmp15 gene expression on PCOS patients undergoing intracytoplasmic sperm injection(ICSI).
详细描述
This study was conducted in Infertility clinic of Mahdiyeh Educational Hospital, Tehran. Patients in the four groups receive the drug 2 months before the start of the ovulation cycle, and treatment will continue until the day of the oocyte aspiration. The drug provide by midwife to patients and both patient and physician blind to the treatment regimen. The participants randomly divide into four groups.The ovulation induction stimulate with GnRh antagonist.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subject has clinical or biochemical hyperandrogenic symptoms
- •subject has oligo/amenorrhea cycles
排除标准
- •Hypersensitivity to metformin
- •Hypersensitivity to sitagliptin presence of infertility factors other than anovulation,
- •male infertility
- •pelvic organic pathologies
- •congenital adrenal hyperplasia
- •thyroid dysfunction
- •Cushing's syndrome
- •hyper prolactinemia
- •androgen secreting neoplasia
- •diabetes mellitus
- •consumption of medications affecting carbohydrate metabolism
- •consumption hormonal analogues other than progesterone 2 months prior to enrolment in the study
- •severe hepatic
- •pancreatitis
- •kidney diseases
- •gallbladder diseases
研究组 & 干预措施
sitagliptin/metformin
Intervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily
干预措施: Sitagliptin/metformin (Drug)
Placebo
Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
干预措施: placebo (Drug)
Metformin
Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily
干预措施: metformin (Drug)
Sitagliptin
Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Fasting insulin
时间窗: 24 hours after last dose
ELIZA hormone assay
Growth differentiation factor-9(GDF-9) expression
时间窗: 24 hours after last dose
Realtime PCR
Follicle-stimulating hormone(FSH)
时间窗: 24 hours after last dose
ELIZA hormone assay
Bone morphogenetic protein-15(BMP-15) expression
时间窗: 24 hours after last dose
Realtime PCR
Total Testosterone
时间窗: 24 hours after last dose
ELIZA hormone assay
次要结局
未报告次要终点
研究者
Delbar Daneshjou
Principal Investigator
Shahid Beheshti University of Medical Sciences