Effects of Supplementation With Myo-inositol, Vitamin D3, Folic Acid and Melatonin on IVF Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- clinical pregnancy
研究概览
简要总结
Administration of a multicomponent dietary supplement (myo-inositol, vitamin D3, folic acid and melatonin) to women undergoing IVF procedures.
The aim of the study is to monitor the effects on the pregnancy, implantation and abortion rates.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI (kg/m2): 18.5 - 24.9
- •basal FSH on day 3 <15 mIU/ml
排除标准
- •presence of insulin resistance (IR)
- •hyperglycaemia, hyperprolactinemia, hypothyroidism or androgen excess
- •diagnosis of PCOS (according to Rotterdam ESHRE-ASRM Sponsored PCOS consensus workshop group)
- •intake of hormones or drugs that can potentially influence the ovulation
- •FSH>15 on day 3
研究组 & 干预措施
Control group
干预措施: control group (Dietary Supplement)
Study group
干预措施: study group (Dietary Supplement)
结局指标
主要结局
clinical pregnancy
时间窗: Single time-point: at 14 days from embryo transfer
Positive beta-hCG test after embryo transfer
Implantation rate
时间窗: Single time-point: at 6 weeks of pregnancy
number of gestational sacs observed at ecographic screening divided by the number of embryos transferred
oocyte and embryo quality
时间窗: Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation
Classification of the morphological aspects under the optical microscope
次要结局
- Gemellarity(Single time-point: at 6 weeks of pregnancy)
- Abortion rate(Single time-point: at 6 weeks of pregnancy)
- Number of FSH IU used for controlled ovarian hyperstimulation(Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation)