Comparison of the Effect of a Combination of Myoinositol:D-chiro-inositol With Low Proportion of DCI (40:1) Versus a Combination With a Higher Proportion of DCI (3.6:1) in the Oocyte Quality and Pregnancy Rates in Women With PCOS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Pregnancy rate
研究概览
简要总结
The aim of the present study is to evaluate the effect of increasing the proportion of D-chiro-inositol (DCI) in a combination with myo-inositol (MYO) in improving fertility in women with polycystic ovarian syndrome (PCOS). Sixty women diagnosed with PCOS will randomly take twice a day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol or capsules containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.
详细描述
Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy in women of childbearing age. It affects 4-8% of the population and of them, approximately 74% present anovulatory cycles and, therefore, fertility problems.
Both myo-inositol and D-chiro-inositol are 2 natural substances that have been shown to improve ovarian function and metabolism in women with polycystic ovarian syndrome.
The aim of the present study is to compare the effect of 2 ratios of myo-inositol /D-chiro-inositol on parameters related to the fertility of women with PCOS.
It is a multicenter, controlled, randomized, double-blind, parallel-group, 12-week clinical trial which will be conducted in 13 public and private hospitals from Spain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with PCOS according to Rotterdam criteria.
- •Being in in vitro fertilization treatment.
- •Body mass index less than 30 kg/m
- •Accept freely to participate in the study and sign the informed consent document.
排除标准
- •Contraindication to perform techniques of assisted reproduction or stimulation of ovulation.
- •Advanced state of endometriosis (III or IV).
- •Classified as poor responder in fertility treatment.
- •Premature ovarian failure.
- •Severe male factor (cryptozoospermia).
- •Few expectations of compliance and/or collaboration.
研究组 & 干预措施
550 mg of MYO and 150 mg of DCI
Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol.
干预措施: Myoinositol (Drug)
550 mg of MYO and 150 mg of DCI
Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol.
干预措施: D-chiro-inositol (Drug)
550 mg of MYO and 13.8 mg of DCI
Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.
干预措施: D-chiro-inositol (Drug)
550 mg of MYO and 13.8 mg of DCI
Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.
干预措施: Myoinositol (Drug)
结局指标
主要结局
Pregnancy rate
时间窗: 12 weeks
Number of pregnancies
次要结局
- IM/VG oocytes(12 weeks)
- Grade I, II, III embryos(12 weeks)
- Gestational sacs(12 weeks)
- Total testosterone(12 weeks)
- Mature MII oocytes(12 weeks)
- Days of stimulation(12 weeks)
- Glucose(12 weeks)
- Insulin(12 weeks)
- Transferred embryos(12 weeks)