Clomiphene Citrate Stair-step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Occurrence of the ovulation by transvaginal ultrasound
研究概览
简要总结
A RCT will be conducted to compare the traditional clomiphene citrate regimens for ovulation induction with the stair-step protocol. Sixty women will be included after obtaining their written informed consent and will be randomized into either of the 2 groups.
详细描述
This study is a randomized clinical trial (RCT) will be conducted in Ain Shams University maternity hospital at infertility clinic within a period of 6-8 months.
All patient are previously diagnosed as PCOs according to the Rotterdam conference of 2003.
All patients will be devided according to computer based program into two groups First group: Patients with traditional protocol
Traditional protocol:
Clomiphene citrate (clomid) (50mg) will be given for 5 days (days 3-7). Transvaginal ultrasound from 9th-20th every other day if ovulation occur the patient will be excluded if no ovulation, we will wait for the next menses and increase the dose to (100mg). if no ovulation occurred increase the dose to (150mg) in the next cycle if no ovulation increase the dose to (200mg) TVUS from 9th-20th ovary other day. If no ovulation we will wait for next cycle and increase the dose to (250mg) and so till 6 cycles .
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
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 20-35 years.
- •Body mass index (BMI/m2) 26-35 kg/m2
- •Normal hystrosalpingogram (HSG).
- •Normal Prolactin level.
- •Normal semen analysis.
排除标准
- •- They underwent ovarian drilling.
- •Other factors infertility.
- •AUTOimmune diseases as thyroid disorders and systemic lupus erythematosus.
研究组 & 干预措施
Traditional
Clomiphene citrate (50mg) will be given for 5 days (days 3-7). Transvaginal ultrasound from 9th-20th every other day if ovulation occur the patient will be excluded. If no ovulation, we will wait for the next menses and increase the dose to (100mg). if no ovulation occurred increase the dose to (150mg) in the next cycle if no ovulation increase the dose to (200mg) TVUS from 9th-20th ovary other day. If no ovulation we will wait for next cycle and increase the dose to (250mg) and so till 6 cycles.
干预措施: Clomiphene Citrate 50mg (Drug)
Stair step protocol
If there is no response (no follicle >10mm), so, (100mg) clomiphene will be initiated immediately for 5 days and ultrasound will be repeated 1 week after the first ultrasound. If there is no response, (150mg) clomiphene will be initiated immediately for another 5 days and TV/US will be performed 1 week after the second TV/US
干预措施: Clomiphene Citrate 50mg (Drug)
结局指标
主要结局
Occurrence of the ovulation by transvaginal ultrasound
时间窗: 20 days
* Follicle suddenly disappears or regresses in size. * Irregular margins. * Intra follicular echos. Follicle suddenly becomes more echogenic. * Free fluid in pouch of douglas.
次要结局
- time to achieve ovulation(20 days)
- dose of clomiphene to achieve ovulation(20 days)
研究者
ADEL SHAFIK SALAH EL-DIN
Assistant professor
Ain Shams Maternity Hospital