Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Rate of cumulative ongoing pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after 3 treatment cycles with inositol versus clomiphene citrate for ovulation induction.
研究概览
简要总结
Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled: irregular cycle (shorter than 21 days or longer than 35 days); clinical (modified Ferriman-Gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarian volume ≥ 10 ml, measured with a probe >8 MHz) in both ovaries.
- •A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: mild male factor (as defined by each local center) endometriosis AFS score 1 or 2
- •Use of own or donor sperm.
排除标准
- •Tubal factors
- •Uterine factors
- •Endometriosis AFS score 3 or 4
- •Moderate to severe male factor (as defined by each local center)
- •BMI > 35
研究组 & 干预措施
Inositol group
Myo-inositol 4000 mg Dosing: 2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged) during 3 consecutive treatment cycles.
干预措施: Myo-inositol (Drug)
Clomiphene citrate group
Each tablet contains 50 mg of clomiphene citrate Dosing: 1 tablet per day, per os, from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days during 3 consecutive treatment cycles.
干预措施: Clomiphene Citrate (Drug)
结局指标
主要结局
Rate of cumulative ongoing pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after 3 treatment cycles with inositol versus clomiphene citrate for ovulation induction.
时间窗: At 7 - 8 gestational weeks
Recently, a meta-analysis on the use of inositol in PCOS was published. This study showed that inositol leads to a more regular menstrual cycle and recovery of ovarian function. Less data are present on pregnancy rates. No RCT was found on the comparison between inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate. Another advantage of inositol is that it doesn't have side effects compared to metformin and that there is no elevated risk on multiple pregnancies, which is the case with clomiphene citrate.
次要结局
- The number of potential adverse events(During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks))
- The occurrence of ovulation(During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks))
- The number of cancelled treatment cycles(During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks))
- The number of multiple pregnancies(During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks))