Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Total resistance rate under CC for ovulation induction in patients with PCOS.
研究概览
简要总结
The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Wishing pregnancy,
- •Having PCOS defined by the Rotterdam criteria: high antral follicle count (AFC) (> 19 per ovary) and/or a disorder of the cycle and/or hyperandrogenism (at least two of the three criteria),
- •Having never been treated with CC (or previous treatment with CC interrupted for > 3 months).
- •Having received complete information and having signed consent.
- •Covered by social security
排除标准
- •Intolerance to CC in previous treatment,
- •BMI > 35,
- •Other associated cause of oligoanovulation requiring specific treatment (eg., Hyperprolactinemia or functional hypothalamic anovulation),
- •Ongoing pregnancy at the time of CC initiation,
- •Other male or female cause of hypo-fertility,
- •History of ovarian drilling,
- •Negative rubella serology.
研究组 & 干预措施
Myo-Inositol + Levomefolic acid
The experimental group will receive the dietary supplement: 4 g of MYO + 0.736 mg of 5-MTHF, glucosamine salts per day per os (in 2 bags per day) in addition to the standard therapy (Clomiphene Citrate).
干预措施: Myo-Inositol + Levomefolic acid (Dietary Supplement)
Placebo
The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
干预措施: placebo (Dietary Supplement)
Myo-Inositol + Levomefolic acid
The experimental group will receive the dietary supplement: 4 g of MYO + 0.736 mg of 5-MTHF, glucosamine salts per day per os (in 2 bags per day) in addition to the standard therapy (Clomiphene Citrate).
干预措施: Clomiphene Citrate (Drug)
Placebo
The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
干预措施: Clomiphene Citrate (Drug)
结局指标
主要结局
Total resistance rate under CC for ovulation induction in patients with PCOS.
时间窗: At each cycle during 4 months
The total resistance to CC is defined by failure to ovulate at least one time during 4 subsequent cycles in women requiring 150 mg/day from D2 to D6.
次要结局
- Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)(During one year)
- Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC(At each cycle during one year)
- Rate of drop out(at each cycle during one year)
- Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study(At each cycle during one year)