Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations
研究概览
简要总结
The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.
The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients PCOS (Rotterdam ESHRE / ASRM criteria)
- •Combination of at least two of the following three criteria:
- •Cycle disorder
- •Clinical hyperandrogenism and / or biological
- •Account antral follicles> 24
- •Age ≤ 18 ≤ 38 years
- •BMI <35 kg / m²
- •Able to understand the protocol and signed informed consent
排除标准
- •Patients not having the Rotterdam criteria
- •Patients> 38 years and / or BMI> 35 kg / m²
- •Woman enjoying a measure of legal protection
- •Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid, glycerol, gelatin, coloring E171)
- •Participation in another interventional biomedical research with treatment administered may disrupt ovarian stimulation
研究组 & 干预措施
Inofolic®
standard ovarian stimulation and Inofolic®
干预措施: Inofolic® (Dietary Supplement)
Inofolic®
standard ovarian stimulation and Inofolic®
干预措施: Gonadotropins; Folic Acid (Other)
Gonadotropins;Folic Acid
standard ovarian stimulation without Inofolic®
干预措施: Gonadotropins; Folic Acid (Other)
结局指标
主要结局
Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations
时间窗: 3 month
次要结局
未报告次要终点