Clomiphene Citrate Co-treatment With Low Dose HP Urinary FSH vs. HP Urinary FSH Step-up Protocol for Clomiphene-citrate Resistant PCOS Anovulatory Infertility: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- ovulation rate
研究概览
简要总结
To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary FSH in these cases.
详细描述
To test whether CC co- treatment with chronic low dose HP uFSH vs chronic low dose HP uFSH in CC resistant PCOS will yield better results in terms of ,ovulation rate, lower follicle number,lower HP uFSH dose ,better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates,lower cycle cancellation.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •CC resistant PCOS
- •Infertile
- •Age 18-38
排除标准
- •Hyperprolactinaemia
- •Cushing syndrome
- •Adult onset adrenal hyperplasia
- •Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis
研究组 & 干预措施
Clomiphene Citrate plus HP uFSH
Starting from the 2nd day of the cycle Clomiphene Citrate( CC)50 mg tablets are given in 100 mg daily dose for 5 days together with an low dose HP uFSH (half ampoule: 37.5 IU) given im daily for 8-10 days.
干预措施: Clomiphine citrate plus low dose uFSH (Drug)
Step-up HP uFSH
HP uFSH started in doses of half ampole (37.5 )IU daily from the 2nd day of cycle for 7 days ,then dose is stepped-up to one ampoule ( 75 IU) for 7 days then the one and a half amps (112.5) IU /day until follicular diameter reaches 18 mm mean diameter
干预措施: Step-up HP u FSH (Drug)
结局指标
主要结局
ovulation rate
时间窗: 6 months
IF CC Co-treatment with low dose step-up HP urinary(u)FSH results in similar or higher ovulation rate compared with step-up low dose HP uFSH
次要结局
- Live birth rate(6 months)
- number of follicles sized 16 mm or more mean diameter in both ovaries at the time of hCG(3 months)
- Endometrial thickness(3 months)
- serum Estradiol(E2)(3 months)
- incidence of multiple pregnancy(3 months)
- costs per cycle(3 months)
- cost effectiveness ratio(6 months)
- clinical and biochemical predictors of response to treatment(6 weeks)
研究者
Mohamad Elsaid Ghanem
Dr
Mansoura Integrated Fertility Center